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

Model Number TF-19A

Device Problem Backflow (1064)

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

Event Date 02/22/2020

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

On (b)(6) 2013, a 19mm trifecta valve was implanted.On (b)(6) 2020, the valve was explanted due to premature valve deterioration.The valve was replaced with a percival size s suture less valve.The patient status is unknown.Additional information has been requested but at this time cannot be obtained.

Manufacturer Narrative

Explant was reported due to valve deterioration.The investigation found that all three leaflets contained calcifications and tears.There was fibrous pannus ingrowth on the outflow surface of leaflets 1 and 2 as well as circumferential fibrous pannus ingrowth on the inflow surface which narrowed the inflow diameter.There was fibrous thickening of all three leaflets.No inflammation was present.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The cause of the tears could not be conclusively determined, however all of the tears were associated with calcifications.

• Brand Name: SJM TRIFECTA VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, COSTA RICA LTDA; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 01897 -405; CS 01897-4050
• Manufacturer (Section G): ST. JUDE MEDICAL, COSTA RICA LTDA; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 01897 -405; CS 01897-4050
• Manufacturer Contact: pamela yip ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 9851276
• MDR Text Key: 184046432
• Report Number: 3008452825-2020-00148
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 05414734052016
• UDI-Public: 05414734052016
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P100029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/16/2020

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: 08/19/2014
• Device Model Number: TF-19A
• Device Catalogue Number: TF-19A
• Device Lot Number: 3801309
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/25/2020
• Initial Date FDA Received: 03/18/2020
• Supplement Dates Manufacturer Received: 04/13/2020
• Supplement Dates FDA Received: 04/16/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/20/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 75 YR