MAUDE Adverse Event Report: ABBOTT MEDICAL SJM TISSUE HEART VALVE (UNKNOWN); HEART-VALVE, NON-ALLOGRAFT TISSUE

Device Problem Off-Label Use (1494)

Patient Problems Atrial Fibrillation (1729); Stroke/CVA (1770); Endocarditis (1834); Renal Failure (2041); Valvular Stenosis (2697); Pulmonary Valve Insufficiency/ Regurgitation (4452)

Event Type  Injury  

Event Description

Related manufacturer reference number: (b)(4).The article, "bioprosthetic pulmonary valve dysfunction in congenital heart disease", was reviewed.This article is a retrospective single study experience that aims to identify the incidence and timing of dysfunction and failure of stented bioprosthetic valves in the pulmonary position in congenital heart disease patients.Perimount magna, magnaease (edwards life sciences) , trifecta, biocor, epic aortic, supra aortic and mitral valves (abbott) and mosaic, mosaic ultra, mosaic ultra cinch valves (medtronic) were associated with this study.The article concluded porcine stented and bovine pericardial stented valves can be implanted in the pulmonary position in all age groups safely.However, despite similar rates of valve failure, bovine pericardial stented valves have a higher incidence of valve dysfunction at mid-term follow-up.[the primary and corresponding author of this article is (b)(6) md, division of cardiothoracic surgery, (b)(6) university school of medicine, (b)(6).

Manufacturer Narrative

As reported in a research article, complications form having a porcine valve implanted included stroke, cardiac arrest, renal failure, bleeding, extracorporeal membrane oxygenation use, reintubation, endocarditis, pacemaker implant, mediastinal reoperation, thromboembolic event, valve failure due to pulmonary stenosis, pulmonary insufficiency, atrial fibrillation, and paravalvular leak.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.Please note, per the instructions for use for a biocor valve arten(b)(4) revision c "precautions:¿ the safety and effectiveness of the biocor¿ and biocor¿ supra valves have not been established for the following specific populations.Patients requiring pulmonic or tricuspid valve replacement" please note, per the instructions for use for a epic valve arten(b)(4) revision a "precautions: the safety and effectiveness of the epic¿ and epic¿ supra valves have not been established for the following specific populations.Patients requiring pulmonic or tricuspid valve replacement.".

• Brand Name: SJM TISSUE HEART VALVE (UNKNOWN)
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 13589070
• MDR Text Key: 286265546
• Report Number: 3005334138-2022-00126
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 02/02/2022
• 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): Required Intervention
• Patient Age: 19 YR
• Patient Sex: Male
• Patient Weight: 61 KG