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

Model Number	B100-33M-00
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Mitral Regurgitation (1964)
Date of Event	04/19/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2017, a 33 mm biocor valve was implanted.The patient was symptomatic and presented with mitral regurgitation.On (b)(6) 2019, the valve was explanted where a tear was observed and replaced with a 31 mm masters valve.
Additional Manufacturer Narrative
The tear seen at explant was confirmed.Perforations were present on cusp 1, and cusps 2 and 3 contained tears.There was fibrous pannus ingrowth on the inflow surface of cusps 2 and 3.All three cusps had thinning and loss of collagen fibers.No acute inflammation or significant calcifications were present.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications at the time of commercialization.The thinning and loss of collagen fibers seen in the tissue could have contributed to the tears, and the fibrous pannus ingrowth noted had the potential to induce increased stress on adjacent leaflets and create an unbalanced stress relief distribution between all leaflets during coaptation, leading to leaflet tears and reduced durability.

• Brand Name: BIOCOR STENTED PORCINE VALVE W/ FLEXFIT SYSTEM
• Common Device Name: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL; rua professor jose vieira de mendonça 1301; engenho nogueira - belo horizonte - mg; belo horizonte 31310 -260; BR 31310-260
• MDR Report Key: 9224801
• Report Number: 3001883144-2019-00109
• Device Sequence Number: 1573240
• 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: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/02/2019
• Device Model Number: B100-33M-00
• Device Catalogue Number: B100-33M-00
• Device Lot Number: BR00004020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/01/2019
• Supplement Date Received by Manufacturer: 11/25/2019
• Initial Report FDA Received Date: 10/23/2019
• Supplement Report FDA Received Date: 12/12/2019
• 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: 59 YR