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

Model Number TF-23A

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

Patient Problems Aortic Valve Stenosis (1717); Chest Pain (1776); Heart Failure (2206)

Event Date 07/25/2020

Event Type  Injury  

Manufacturer Narrative

Further information regarding this event has been requested.The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

On (b)(6) 2013, a 23mm sjm trifecta valve was implanted in the patient's aortic position due to aortic stenosis and calcification of the patient's congenital aortic bicuspid valve.An abbott sizer was used in the surgery and the trifecta valve was successfully implanted with non-everting mattress suture technique using pledgets.During a follow-up in (b)(6) 2020, there was no problem found in the echocardiogram examination.In mid (b)(6) 2020, the patient presented to the hospital complaining of chest pain and the heart failure was treated by medication.However, the patient's symptom worsened and severe aortic stenosis was confirmed on (b)(6) 2020.An emergency re-do avr was performed on the same date, and the trifecta valve was explanted and replaced with a 21mm edwards intuity elite valve system(by edwards lifesciences).After opening the patient's chest, a vertical tear from the middle of the lcc and the ncc stent post leading to nadir was confirmed visually, thus the surgeon attributed the issue to the leaflet tear of the trifecta valve.The patient is recovering well post-operatively.

Manufacturer Narrative

This report is submitted under the incorrect manufacturing report number.The correct manufacturing report number is (b)(4).Explant was reported due to chest pain, stenosis, and heart failure.The investigation confirmed that leaflets 2 and 3 were torn.Circumferential fibrous pannus ingrowth was present, which narrowed the inflow diameter.No 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 not demonstrate loss of collagen at the tear site.The implanted trifecta valve size (23 mm) being larger than the replacement valve (21 mm) and the pannus formation noted is possible evidence of oversizing.The oversizing would have 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, BRASIL LTDA. (PAMPULHA); rua professor jose vieira de mendonça 1301; engenho nogueira - belo horizonte - mg; belo horizonte 31310 -260; BR 31310-260
• MDR Report Key: 10500078
• MDR Text Key: 205887574
• Report Number: 3008452825-2020-00439
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 05414734052030
• UDI-Public: 05414734052030
• 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: 11/11/2020

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/19/2015
• Device Model Number: TF-23A
• Device Catalogue Number: TF-23A
• Device Lot Number: 4127373
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/13/2020
• Initial Date FDA Received: 09/07/2020
• Supplement Dates Manufacturer Received: 10/23/2020
• Supplement Dates FDA Received: 11/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR