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

Model Number TF-21A

Device Problems Backflow (1064); Material Perforation (2205); Incomplete Coaptation (2507)

Patient Problems Aortic Regurgitation (1716); Prolapse (2475)

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

On (b)(6) a 2015, 21mm sjm trifecta valve was implanted in the patient's aortic position with 12 vertical mattress sutures.Two-vessel coronary artery bypass graft surgery was performed at the same time, due to heart failure and myocardial infarction.During a follow up in (b)(6) 2015, mild aortic regurgitation was noted.There was no other events observed during the consequent follow ups.During the end of (b)(6) 2019, severe aortic regurgitation was confirmed and was thought to be due to prolapse leaflet of the valve.It is not known when the prolapse of the cuff started.Echocardiogram from (b)(6) 2020 indicated increased regurgitation.In (b)(6) 2020, chronic heart failure worsened.On (b)(6) 2020, the patient was hospitalized and scheduled for valve explant.On (b)(6) 2020, a re-do aortic valve replacement was performed as planned.The trifecta valve was explanted and replaced with a 21mm inspiris resilia aortic valve(manufacturer: edwards lifesciences).Upon explant, the valve dysfunction near the stent was confirmed, and the cause of the aortic regurgitation was found out to be due to leaflet perforation on the upper part of the commissure between the left coronary cusp (lcc) and the right coronary cusp (rcc).The patient is in stable condition postoperatively.

Manufacturer Narrative

Explant was reported due to regurgitation and worsening heart failure.The investigation found that there was circumferential fibrous pannus ingrowth on the inflow surface, which extended onto all three leaflets and narrowed the inflow diameter.There was a tear in leaflets 2 and 3.Leaflets 1 and 3 were folded.Degenerative changes were present in leaflet 2 at the site of the tear.No acute inflammation or significant calcifications were 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 cause of the tear could not be conclusively determined; however, the degenerative changes noted at the tear site could have contributed, as well as the fibrous pannus ingrowth which 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 (CVD); 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: 9931804
• MDR Text Key: 186712547
• Report Number: 3008452825-2020-00184
• 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
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 06/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/27/2015
• Device Model Number: TF-21A
• Device Catalogue Number: TF-21A
• Device Lot Number: 4252159
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 76 YR
• Patient Weight: 42