MAUDE Adverse Event Report: ST. JUDE MEDICAL PUERTO RICO, INC. SJM® MECHANICAL HEART VALVE; HEART-VALVE, MECHANICAL

Device Problem Backflow (1064)

Patient Problems Atrial Fibrillation (1729); Stroke/CVA (1770); Endocarditis (1834); Hemorrhage/Bleeding (1888); Aortic Valve Insufficiency/ Regurgitation (4450); Renal Impairment (4499)

Event Type  Injury  

Event Description

Related manufacturer reference number: 3014918977-2022-00005.The article, "early and midterm clinical outcomes of transcatheter valve-in-valve implantation versus redo surgical aortic valve replacement for aortic bioprosthetic valve degeneration: two faces of the same medal", was reviewed.This research article is a retrospective observational study to compare early and midterm outcomes of transcatheter valve-in-valve implantation (viv-tavi) and redo surgical aortic valve replacement (re-savr) for aortic bioprosthetic valve degeneration.Edwards sapien, edward sapien 3, edward sapien xt, carpentier edwards, toronto freestyle stentless, hancock 2, mitroflow, st jude portico, trifecta valve, medtronic ultra porcine (mosaic) corevalve evolute, carbomedics mechanical, magna ease, perceval, and st jude mechanical were associated with this study.The article concluded that viv-tavi is a safe, feasible, and reliable procedure.This is supported from the primary and secondary endpoint outcomes obtained from the two cohorts.The primary and correspondence author is aleksander dokollari, md, department of cardiac surgery, (b)(6).

Manufacturer Narrative

As reported in a research article, 88 patient were included in the analysis from january 2010 to july 2018; 31 patients underwent transcatheter valve-in-valve implantation and 57 patients underwent redo surgical aortic valve replacement.Edwards sapien, edward sapien 3, edward sapien xt, carpentier edwards, toronto freestyle stentless, hancock 2, mitroflow, st jude portico, trifecta valve, medtronic ultra porcine (mosaic) corevalve evolute, carbomedics mechanical, magna ease, perceval, and st jude mechanical were associated with this study.Events of postoperative regurgitation, "leak", "readmission to icu", re-intubation, atrial fibrillation, acute kidney insufficiency, "stroke or tia", pacemaker implant, infection, reoperation for bleeding, red blood cell transfusion, platelet transfusion, plasma transfusion, endocarditis, re-intervention, and heart failure were reported.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device was received for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: SJM® MECHANICAL HEART VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725 ; * 00725
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725 ; * 00725
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 13252213
• MDR Text Key: 289014844
• Report Number: 2648612-2022-00006
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/28/2021
• 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): Hospitalization; Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 74 KG