MAUDE Adverse Event Report: ST. JUDE MEDICAL, BRASIL LTDA. (PAMPULHA) BIOCOR STENTED PORCINE VALVE W/ FLEXFIT SYSTEM; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number B100-33M

Device Problem Backflow (1064)

Patient Problem Mitral Regurgitation (1964)

Event Date 11/17/2020

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

On (b)(6) 2020, the physician sized the mitral valve and a 33mm biocor stented porcine valve was selected for implant in the patient.Upon closure, mitral regurgitation was observed on echo.Initially, it was thought that a wrong size was used now the thought is that it was a faulty valve.The physician resized the mitral valve and selected a 31mm biocor stented porcine valve.The 31mm valve was implanted with better outcomes.

Manufacturer Narrative

An event of regurgitation was reported.No anomalies were found with the valve cusps, and functional testing at the time of manufacturing and upon return to abbott indicated the valve functioned normally.This test ensures proper cuspal coaptation and hemodynamic performance.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.In the absence of any evidence of valve anomaly that may impact valvular function, the reported event is consistent with a non-structural valve dysfunction.Non-structural valve dysfunction (nsvd) is a known potential complication of valve replacement surgery as outlined in the instructions for use.Nsvd is commonly attributed to implant-related technical factors such as inappropriate sizing or positioning, entrapment by suture, stent deformation, or mishandling of the leaflet tissue.In this case, it is possible that the valve was inappropriately sized as a smaller (31mm) valve was successfully implanted.Temporary distortion of the stent due to external forces following closure where the stent is not permanently deformed may also potentially explain the observed intraoperative valvular dysfunction.The exact cause of the observed intra-operative regurgitation cannot be conclusively determined.

• Brand Name: BIOCOR STENTED PORCINE VALVE W/ FLEXFIT SYSTEM
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, BRASIL LTDA. (PAMPULHA); rua professor jose vieira de mendonça 1301; engenho nogueira - belo horizonte - mg; belo horizonte 31310 -260; BR 31310-260
• MDR Report Key: 10999444
• MDR Text Key: 221232712
• Report Number: 3001883144-2020-00123
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• PMA/PMN Number: P040021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 02/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/22/2023
• Device Model Number: B100-33M
• Device Lot Number: BR00022285
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention