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

Model Number	B100-33M-00
Medical Device Problem Codes	Backflow (1064); Incomplete Coaptation (2507)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results, method, and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
It was reported that on (b)(6) 2021, a 33mm biocor stented porcine valve w/ flexfit system was selected for implant.The device was successfully implanted and the patient was taken off of bypass.Post-implant echo was performed and showed more mitral regurgitation than usual and a possible prolapse of the leaflet.The patient was placed back on bypass and the valve was removed and replaced with another 33mm biocor stented porcine valve w/ flexfit system to resolve the event.There was no clinically significant delay in the procedure and the patient remained hemodynamically stable throughout.The patient is stable with no consequences.No additional information was provided.
Additional Manufacturer Narrative
An event of mitral regurgitation and leaflet prolapse was reported.The investigation found that cusp 2 was torn.The tear could have contributed to the reported regurgitation if present prior to explant.How or when the valve became torn could not be conclusively determined as the valve was explanted.The tear in the cusp 2 precluded functional testing.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications, including specifications for leaflet coaptation and valve function.The cause of the reported event could not be conclusively determined.

• Brand Name: BIOCOR STENTED PORCINE VALVE W/ FLEXFIT SYSTEM
• Common Device Name: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, BRASIL LTDA.; rua professor jose vieira de mendonça 1301; engenho nogueira - belo horizonte - mg; belo horizonte 31310 -260; BR 31310-260
• MDR Report Key: 12096699
• Report Number: 3001883144-2021-00104
• Device Sequence Number: 11816691
• Product Code: LWR
• UDI-Device Identifier: 05414734055468
• UDI-Public: 05414734055468
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P040021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/27/2024
• Device Model Number: B100-33M-00
• Device Catalogue Number: B100-33M-00
• Device Lot Number: BR00026870
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/02/2021
• Supplement Date Received by Manufacturer: 07/14/2021
• Initial Report FDA Received Date: 06/30/2021
• Supplement Report FDA Received Date: 07/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR