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

Model Number TF-21A

Device Problems Calcified (1077); Gradient Increase (1270)

Patient Problems Atrial Fibrillation (1729); Dyspnea (1816); Fatigue (1849); Pleural Effusion (2010)

Event Date 01/23/2020

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) 2013, a 21mm trifecta valve was implanted.Post implant procedure the patient was hospitalized longer due to pleural effusions and atrial fibrillation.In 2017 an echocardiogram was performed and increase gradient was reported.The patient was reported to being doing fine until 2019.The patient was experiencing dyspnea and fatigue.An echocardiogram as preformed at follow-up and increase gradient was reported (80 mmhg).The valve was explanted on (b)(6) 2020, calcification was reported on the right left coronary commissure, one leaflet was reported to be mobile (the non-coronary cusp).Post explant, when examining the valve it was noted that the sewing right was destroyed which happened while explanting the valve.A new 21mm trifecta gt valve was implanted and the patient was reported to be in stable condition.

Manufacturer Narrative

Additional information: pma/510k, device evaluated by mfr.The reported calcification was confirmed.All three leaflets contained calcifications, with circumferential fibrous pannus ingrowth on the inflow and outflow surfaces.The calcification and pannus restricted mobility of all 3 leaflets.Leaflets 1 and 3 contained tears.All 3 leaflets were mildly fibrotically thickened.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 at the time of commercialization.The extent of pannus on the valve stent posts is possible evidence of interaction with the aortic wall.The host to device reaction (calcification and pannus) caused leaflet immobility is consistent with the reported high gradient.

• 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 1897- 4050; CS 1897-4050
• MDR Report Key: 9756448
• MDR Text Key: 183088094
• Report Number: 3008452825-2020-00125
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 05414734052023
• UDI-Public: 05414734052023
• 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: 03/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/21/2014
• Device Model Number: TF-21A
• Device Catalogue Number: TF-21A
• Device Lot Number: 3640587
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 79 YR