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

Model Number TF-21A

Device Problem Leak/Splash (1354)

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

Event Date 09/04/2019

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

In 2009, a 21mm trifecta valve was implanted at lankenau hospital.On (b)(6) 2019, the valve was explanted due to aortic insufficiency.The patient is reportedly stable.Additional information requested.

Event Description

In 2009, a 21mm trifecta valve was implanted at (b)(6) hospital.On (b)(6) 2019, the valve was explanted due to aortic insufficiency.The patient is reportedly stable.No further information is available.

Manufacturer Narrative

An event of explant of the valve due to aortic insufficiency was reported.The results of the investigation are inconclusive since the device was not returned for analysis.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 CATD; 4 robbins drive; westford MA 01886
• MDR Report Key: 9144953
• MDR Text Key: 160866145
• Report Number: 3007113487-2019-00028
• Device Sequence Number: 1
• Product Code: LWR
• 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
• Type of Report: Initial,Followup
• Report Date: 10/16/2019

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
• Device Operator: Health Professional
• Device Model Number: TF-21A
• Device Catalogue Number: TF-21A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/04/2019
• Initial Date FDA Received: 10/02/2019
• Supplement Dates Manufacturer Received: 09/22/2019
• Supplement Dates FDA Received: 10/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 87