MAUDE Adverse Event Report: ABBOTT MEDICAL SJM TRIFECTA VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number TF-A

Device Problems Calcified (1077); Device Stenosis (4066)

Patient Problem Dyspnea (1816)

Event Type  Injury  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Na.

Event Description

It was reported that on (b)(6) 2022, a 23mm trifecta valve was successfully implanted.On an unknown date, exercise-related shortness of breath and stenosis of the native aortic valve was noted.The patient was admitted due to stenosis of the anterior ramus interventricularis and carotistenose.Echocardiogram showed the following eoa: 0,6 cm2 (420mtr/sec).On (b)(6) 2022 the device was explanted and a non-abbott device was implanted.Upon explant, the valve was heavily calcified; no tears were observed but the valve was noted as "stiff".The patient was reported to be in stable condition.

Manufacturer Narrative

Explant due to stenosis of the valve was reported.The investigation found that all three leaflets contained calcifications, which limited the leaflet mobility.There was circumferential fibrous pannus ingrowth on the inflow surface of the valve.A tear was found in leaflet 2 which was associated with a calcification.There was a thin layer of fibrin on the outflow surface at the base of leaflet 1.No acute 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 calcifications and pannus noted on the valve could have contributed to the reported stenosis.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• Brand Name: SJM TRIFECTA VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL #3014918977; edificio #44 calle 0, ave. 2; el coyol alajuela 1897- 4050; CS 1897-4050
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 15959967
• MDR Text Key: 305268880
• Report Number: 2135147-2022-02493
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 05414734052030
• UDI-Public: 05414734052030
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P100029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/08/2023

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: 01/18/2017
• Device Model Number: TF-A
• Device Catalogue Number: TF-23A
• Device Lot Number: 4973877
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/23/2022
• Initial Date FDA Received: 12/12/2022
• Supplement Dates Manufacturer Received: 02/23/2023
• Supplement Dates FDA Received: 03/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2015
• 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): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Race: White