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

Model Number TF-19A

Device Problems Backflow (1064); Calcified (1077); Obstruction of Flow (2423); Incomplete Coaptation (2507); Biocompatibility (2886)

Patient Problems Aortic Valve Stenosis (1717); Heart Failure/Congestive Heart Failure (4446); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 05/25/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that on (b)(6) 2015, a 19mm trifecta valve was implanted in the patient's aortic position.In (b)(6) 2021, heart failure symptoms were observed and the patient was monitored until the symptoms subsided.Then, on (b)(6) 2021, a re-do aortic valve replacement (avr) procedure was performed and the trifecta valve was explanted.Upon explant, the right coronary cusp (rcc) was sclerosed and was prolapsed, causing aortic stenosis and regurgitation.Pannus was observed on the inflow side.A non-abbott device was successfully implanted.The patient was reported to be in stable condition.

Manufacturer Narrative

Explant was reported due to heart failure symptoms.Also reported was that the leaflet on the right coronary cusp side was sclerosed and was prolapsed, and that there was pannus on the inflow side of the valve.The investigation found that leaflet 2 was torn, leaflet 2 had a partial thickness tear, and leaflet 3 had an incision.There was circumferential fibrous pannus ingrowth on the inflow surface with narrowing of the inflow diameter.All three leaflets had calcifications.There was fibrous thickening of all three leaflets.There was no acute inflammation.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 calcifications and tear could not be conclusively determined; however, the fibrous pannus ingrowth noted had the potential to induce increased stress on adjacent leaflets and create an unbalanced stress relief distribution between all leaflets during coaptation, leading to leaflet tears and reduced durability.

• 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
• MDR Report Key: 11921614
• MDR Text Key: 253774009
• Report Number: 3014918977-2021-00007
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 05414734052016
• UDI-Public: 05414734052016
• 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: 07/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/15/2016
• Device Model Number: TF-19A
• Device Catalogue Number: TF-19A
• Device Lot Number: 4969918
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 86 YR
• Patient Weight: 46