MAUDE Adverse Event Report: ABBOTT MEDICAL MASTERS SERIES MECHANICAL HEART VALVE; HEART-VALVE, MECHANICAL

Catalog Number UNK MASTERS MHV

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); Hemorrhage/Bleeding (1888); Renal Failure (2041)

Event Date 01/01/2011

Event Type  Death  

Manufacturer Narrative

Literature article: valve-in-valve transcatheter aortic valve replacement versus isolated redo surgical aortic valve replacement.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

This article, ¿valve-in-valve transcatheter aortic valve replacement versus isolated redo surgical aortic valve replacement¿, was reviewed.The article presents a retrospective single-center study aimed at to compare outcomes of patients undergoing valve-in-valve transcatheter aortic valve replacement (viv tavr) versus redo surgical aortic valve replacement (savr).Devices used in transcatheter valve replacement procedures included evolut, corevalve, evolut pro, evolut pro plus, portico, sapien 3, sapien 3 ultra, sapien xt.Devices used in surgical valve replacement procedures included st.Jude medical regent, on-x, st.Jude medical masters, carpentier edwards perimount, epic, trifecta, freestyle, sorin mitroflow, inspiris, avalus.The article concluded that viv tavr and redo savr were associated with comparable mortality.Patients who underwent redo savr had lower postoperative mean gradients and greater freedom from heart failure readmissions, but they also had more postoperative complications than the viv group, despite their lower baseline risk profiles.[the primary and corresponding author was ibrahim sultan, division of cardiac surgery, department of cardiothoracic surgery, university of pittsburgh, with corresponding email: sultani@upmc.Edu].The time frame of the study was from 2011-2022 for savr and 2013-2022 for tavr.A total of 198 viv tavrs and 147 redo savrs were included in this study.The average age was 72.3 years (65.0 years = redo savr, 79.5 years = viv tavr) and the average gender was male (66.0% = redo savr, 57.6% = viv tavr).Comorbidities included diabetes, hypertension, peripheral vascular disease, cerebrovascular disease, chronic lung disease, chronic dialysis, aortic stenosis, aortic regurgitation, prior cabg, prior percutaneous coronary intervention.

Manufacturer Narrative

Summarized patient outcomes/complications valve-in-valve transcatheter aortic valve replacement versus isolated redo surgical aortic valve replacement were reported in a research article in a subject population with multiple co-morbidities including diabetes, hypertension, peripheral vascular disease, cerebrovascular disease, chronic lung disease, chronic dialysis, aortic stenosis, aortic regurgitation, prior cabg, prior percutaneous coronary intervention.Some of the complications reported were death, renal failure, stroke, bleeding, surgical intervention, unexpected medical intervention, hospitalization, myocardial infarction these complications are anticipated for the procedure.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device or individual patient information was received for analysis.

• Brand Name: MASTERS SERIES MECHANICAL HEART VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, INC. REG#2648612; 20 b st caguas west park; caguas 00725 ; * 00725
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 17440096
• MDR Text Key: 320195848
• Report Number: 2135147-2023-03337
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK MASTERS MHV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death