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

Model Number TF-21A

Device Problems Backflow (1064); Obstruction of Flow (2423); Biocompatibility (2886); Material Split, Cut or Torn (4008)

Patient Problems Aortic Valve Stenosis (1717); Dyspnea (1816); Dizziness (2194); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 04/13/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On (b)(6) 2015, a 21mm trifecta valve was implanted.Follow-ups were performed once a year post-implant with no reported issues until (b)(6) 2020.In (b)(6) 2021, the patient experienced heart failure symptoms, including dyspnea and dizziness, and was diagnosed with aortic stenosis and aortic regurgitation.On (b)(6) 2021, re-do aortic valve replacement (avr) was performed and the trifecta valve was explanted.Upon explant, tears were confirmed on the right coronary cusp (rcc) - non-coronary cusp (ncc) and the left coronary cusp (lcc) - rcc.Additionally, pannus formation was observed on the inflow side of the trifecta valve.A new competitor's 25mm inspiris resilia aortic valve (manufacturer: edwards lifesciences) was successfully implanted.The patient was reported to be in stable condition.

Manufacturer Narrative

Additional information sections: d9, h6, h10 explant was reported due to heart failure symptoms.The investigation found that all three leaflets were torn.Leaflets 1 and 3 contained a fold/ leaflet 1 was fibrously thickened.There was circumferential fibrous pannus ingrowth on the inflow surface which narrowed the inflow diameter and extended onto the bases of all three leaflets.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.In the absence of any calcification or evidence for infection, the reported event is consistent with a non-calcific leaflet tear.A non-calcific leaflet tear is a form of structural valve deterioration (svd), which is a well-known complication from valve replacement surgery.A non-calcific leaflet tear is commonly attributed to increased operational leaflet stress but may also be related to biological factors which result in tissue degeneration characterized by loss of collagen.In this case, histological evaluation did demonstrate loss of collagen at the tear site, which could have contributed to the formation of the tear.In addition, 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 (SH); 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: 11732161
• MDR Text Key: 247591134
• Report Number: 3008452825-2021-00241
• 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: 06/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/10/2016
• Device Model Number: TF-21A
• Device Catalogue Number: TF-21A
• Device Lot Number: 4734776
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Weight: 55