[1]
Runciman W, Hibbert P, Thomson R, Van Der Schaaf T, Sherman H, Lewalle P. Towards an International Classification for Patient Safety: key concepts and terms. International journal for quality in health care : journal of the International Society for Quality in Health Care. 2009 Feb:21(1):18-26. doi: 10.1093/intqhc/mzn057. Epub
[PubMed PMID: 19147597]
Level 2 (mid-level) evidence
[2]
Case BC, Kumar S, Yerasi C, Forrestal BJ, Musallam A, Chezar-Azerrad C, Khalid N, Shlofmitz E, Chen Y, Khan JM, Satler LF, Ben-Dor I, Hashim H, Bernardo NL, Rogers T, Waksman R. Real-world experience of suture-based closure devices: Insights from the FDA Manufacturer and User Facility Device Experience. Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions. 2021 Sep:98(3):572-577. doi: 10.1002/ccd.29501. Epub 2021 Feb 4
[PubMed PMID: 33539651]
Level 3 (low-level) evidence
[3]
Case BC, Yerasi C, Forrestal BJ, Kumar S, Musallam A, Chezar-Azerrad C, Khalid N, Shlofmitz E, Khan JM, Satler LF, Ben-Dor I, Rogers T, Waksman R. Real-World Experience of the MANTA Closure Device: Insights From the FDA Manufacturer and User Facility Device Experience (MAUDE) Database. Cardiovascular revascularization medicine : including molecular interventions. 2021 Jun:27():63-66. doi: 10.1016/j.carrev.2020.11.023. Epub 2020 Nov 20
[PubMed PMID: 33402323]
Level 3 (low-level) evidence
[4]
Ensign LG, Cohen KB. A Primer to the Structure, Content and Linkage of the FDA's Manufacturer and User Facility Device Experience (MAUDE) Files. EGEMS (Washington, DC). 2017 Jun 14:5(1):12. doi: 10.5334/egems.221. Epub 2017 Jun 14
[PubMed PMID: 29930960]
[5]
Khalid N, Javed H, Shlofmitz E, Chen Y, Dheendsa A, Musallam A, Khan JM, Wermers JP, Case BC, Forrestal BJ, Chezar-Azerrad C, Yerasi C, Rogers T, Hashim H, Ben-Dor I, Bernardo NL, Satler L, Waksman R. Adverse Events and Modes of Failure Related to Rotational Atherectomy System: The Utility of the MAUDE Database. Cardiovascular revascularization medicine : including molecular interventions. 2021 Jun:27():57-62. doi: 10.1016/j.carrev.2020.08.038. Epub 2020 Aug 27
[PubMed PMID: 33071196]
Level 3 (low-level) evidence
[6]
Case BC, Forrestal BJ, Yerasi C, Khan JM, Khalid N, Shlofmitz E, Chen Y, Musallam A, Chezar-Azerrad C, Satler LF, Ben-Dor I, Rogers T, Waksman R. Real-World Experience of the Sentinel Cerebral Protection Device: Insights From the FDA Manufacturer and User Facility Device Experience (MAUDE) Database. Cardiovascular revascularization medicine : including molecular interventions. 2020 Feb:21(2):235-238. doi: 10.1016/j.carrev.2019.11.014. Epub 2019 Nov 22
[PubMed PMID: 31780421]
Level 3 (low-level) evidence
[7]
Khalid N, Javed H, Ahmad SA, Edelman JJ, Shlofmitz E, Chen Y, Musallam A, Rogers T, Hashim H, Bernardo NL, Waksman R. Analysis of the Food and Drug Administration Manufacturer and User Facility Device Experience Database for Patient- and Circuit-Related Adverse Events Involving Extracorporeal Membrane Oxygenation. Cardiovascular revascularization medicine : including molecular interventions. 2020 Feb:21(2):230-234. doi: 10.1016/j.carrev.2019.11.011. Epub 2019 Nov 20
[PubMed PMID: 31767523]
[8]
Khalid N, Javed H, Rogers T, Hashim H, Shlofmitz E, Wermers JP, Chen Y, Musallam A, Khan JM, Torguson R, Bernardo NL, Waksman R. Adverse events with orbital atherectomy: an analytic review of the MAUDE database. EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology. 2020 Jul 17:16(4):e325-e327. doi: 10.4244/EIJ-D-19-00295. Epub 2020 Jul 17
[PubMed PMID: 31422928]
[9]
Chen Y, Shah AA, Shlofmitz E, Khalid N, Musallam A, Khan JM, Iantorno M, Gajanana D, Rogers T, Hashim H, Bernardo NL, Waksman R. Adverse Events Associated with the Use of Guide Extension Catheters during Percutaneous Coronary Intervention: Reports from the Manufacturer and User Facility Device Experience (MAUDE) database. Cardiovascular revascularization medicine : including molecular interventions. 2019 May:20(5):409-412. doi: 10.1016/j.carrev.2019.02.016. Epub 2019 Feb 18
[PubMed PMID: 31079818]
[10]
Khalid N, Javed H, Rogers T, Hashim H, Shlofmitz E, Chen Y, Khan JM, Musallam A, Torguson R, Bernardo NL, Waksman R. Adverse events and modes of failure related to the FilterWire EZ Embolic Protection System: Lessons learned from an analytic review of the FDA MAUDE database. Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions. 2019 Jul 1:94(1):157-164. doi: 10.1002/ccd.28297. Epub 2019 Apr 15
[PubMed PMID: 30985082]
[11]
Shlofmitz E, Garcia-Garcia HM, Rogers T, Khalid N, Chen Y, Kajita AH, Khan JM, Iantorno M, Gallino RA, Bernardo NL, Hashim H, Torguson R, Waksman R. Techniques to Optimize the Use of Optical Coherence Tomography: Insights from the Manufacturer and User Facility Device Experience (MAUDE) Database. Cardiovascular revascularization medicine : including molecular interventions. 2019 Jun:20(6):507-512. doi: 10.1016/j.carrev.2019.03.009. Epub 2019 Mar 15
[PubMed PMID: 30962083]
[12]
Galper BZ, Beery DE, Leighton G, Englander LL. Comparison of adverse event and device problem rates for transcatheter aortic valve replacement and Mitraclip procedures as reported by the Transcatheter Valve Therapy Registry and the Food and Drug Administration postmarket surveillance data. American heart journal. 2018 Apr:198():64-74. doi: 10.1016/j.ahj.2017.10.013. Epub 2018 Feb 3
[PubMed PMID: 29653650]
[13]
Friedman DC, Lendvay TS, Hannaford B. Instrument Failures for the da Vinci Surgical System: a Food and Drug Administration MAUDE Database Study. Surgical endoscopy. 2013 May:27(5):1503-8. doi: 10.1007/s00464-012-2659-8. Epub 2012 Dec 14
[PubMed PMID: 23242487]
[14]
Khalid N, Rogers T, Shlofmitz E, Chen Y, Musallam A, Khan JM, Iantorno M, Gajanana D, Hashim H, Torguson R, Bernardo N, Waksman R. Adverse Events and Modes of Failure Related to Impella RP: Insights from the Manufacturer and User Facility Device Experience (MAUDE) Database. Cardiovascular revascularization medicine : including molecular interventions. 2019 Jun:20(6):503-506. doi: 10.1016/j.carrev.2019.03.010. Epub 2019 Mar 16
[PubMed PMID: 30922871]
[15]
Khalid N, Rogers T, Shlofmitz E, Chen Y, Khan JM, Musallam A, Iantorno M, Waksman R. Adverse events and modes of failure related to the Impella percutaneous left ventricular assist devices: a retrospective analysis of the MAUDE database. EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology. 2019 May 20:15(1):44-46. doi: 10.4244/EIJ-D-18-01021. Epub
[PubMed PMID: 30803939]
Level 2 (mid-level) evidence
[16]
Heaton J, Okoh AK, Sossou C, Singh S, Sandhu M, Chakrabarti R, Rao R, Waxman S, Tayal R, Wasty N. Adverse Events After Left Atrial Appendage Closure: Lessons Learned From the Manufacturer and User Facility Device Experience (MAUDE) Database. The Journal of invasive cardiology. 2020 Aug:32(8):E216-E218
[PubMed PMID: 32737269]
[17]
Khalid N, Rogers T, Shlofmitz E, Chen Y, Waksman R. Reply to the letter to the editor "Impella device use in high-risk PCI". EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology. 2019 Oct 20:15(8):732. doi: 10.4244/EIJ-D-19-00279R. Epub
[PubMed PMID: 31625917]
Level 3 (low-level) evidence
[18]
Khalid N, Rogers T, Shlofmitz E, Chen Y, Waksman R. Expanding the Treatment of Calcified Lesions. Cardiovascular revascularization medicine : including molecular interventions. 2019 Jul:20(7):622-623. doi: 10.1016/j.carrev.2019.05.010. Epub 2019 May 13
[PubMed PMID: 31109877]