MAUDE Adverse Event Report: ST. JUDE MEDICAL BRASIL LTDA. SJM TRIFECTA VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number TF-25A

Device Problem Obstruction of Flow (2423)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/06/2020

Event Type  Injury  

Manufacturer Narrative

Further information regarding this event has been requested.Investigation results will be provided in a subsequent submission.

Event Description

On (b)(6) 2011, a 25mm trifecta valve was implanted.On an unknown the patient presented to the hospital with sever valve insufficiency.On (b)(6) 2020, a valve in valve procedure was performed and a 26mm medtronic evolut r was successfully implanted.The patient was reported to be in stable condition.Additional information was requested but cannot be obtained.

Manufacturer Narrative

Additional information: h3, h6.An event of insufficiency in the nearly 9 year old valve was reported.The results of the investigation are inconclusive since the device remains implanted and was not accessible 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: SJM TRIFECTA VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL BRASIL LTDA.; caixa postal 106; belo horizonte 34000 -000; BR 34000-000
• MDR Report Key: 9785605
• MDR Text Key: 188213496
• Report Number: 3001743903-2020-00004
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 05414734052047
• UDI-Public: 05414734052047
• Combination Product (y/n): N
• PMA/PMN Number: P100029
• 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: 03/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/19/2013
• Device Model Number: TF-25A
• Device Catalogue Number: TF-25A
• Device Lot Number: 3369603
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Weight: 88