MAUDE Adverse Event Report: ST. JUDE MEDICAL, BRASIL LTDA. (PAMPULHA) BIOCOR PERICARDIAL HEART VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number B30-31M

Device Problem Biocompatibility (2886)

Patient Problem Thrombosis (2100)

Event Date 06/26/2020

Event Type  Injury  

Manufacturer Narrative

Further information regarding this event has been requested.The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

Reference manufacturing report number 3008452825-2020-00382.On (b)(6) 2017, a 31mm biocor mitral valve and a 23mm trifecta gt valve were implanted.On (b)(6) 2020, both the biocor valve and the trifecta gt valve were explanted due to thrombosis of the valves.A new 29mm edw magna mitral valve and a new 21mm edw magna aortic valve were successfully implanted.The patient is reported to be in stable condition.

Manufacturer Narrative

An event of device thrombosis was reported.A more comprehensive assessment could not be performed as the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: BIOCOR PERICARDIAL HEART VALVE
• 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: 10363351
• MDR Text Key: 201571867
• Report Number: 3001883144-2020-00080
• 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
• Type of Report: Initial,Followup
• Report Date: 10/15/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 11/26/2018
• Device Model Number: B30-31M
• Device Lot Number: BR00005855
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/06/2020
• Initial Date FDA Received: 08/04/2020
• Supplement Dates Manufacturer Received: 10/14/2020
• Supplement Dates FDA Received: 10/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TRIFECTA GT VALVE, SERIAL NUMBER: (B)(6); TRIFECTA GT VALVE, SERIAL NUMBER: (B)(4)
• Patient Outcome(s): Hospitalization; Required Intervention