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

Model Number TFGT-21A

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 02/17/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On (b)(6) 2016, a 21mm trifecta valve was implanted.On (b)(6) 2020, the valve was explanted due to a leaflet tear.A new 19mm regent mechanical heart valve was successfully implanted.No patient consequences were reported.

Manufacturer Narrative

An event of a device explant due to a leaflet tear was reported.The results of the investigation are inconclusive since the device was not returned for analysis; however, three photos were received for analysis.Based solely on the aforementioned photos, the device did appear to have two leaflets which contained a tear.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 CATD; 4 robbins drive; westford MA 01886
• MDR Report Key: 9806105
• MDR Text Key: 182569102
• Report Number: 3008452825-2020-00095
• 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,health
• Type of Report: Initial,Followup
• Report Date: 04/07/2020

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/02/2017
• Device Model Number: TFGT-21A
• Device Catalogue Number: TFGT-21A
• Device Lot Number: 5095503
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/17/2020
• Initial Date FDA Received: 03/09/2020
• Supplement Dates Manufacturer Received: 03/20/2020
• Supplement Dates FDA Received: 04/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Weight: 47