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

Model Number TF-19A

Device Problems Backflow (1064); Material Split, Cut or Torn (4008)

Patient Problems Dyspnea (1816); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that on (b)(6) 2013, a 19mm sjm trifecta valve was implanted in the patient's aortic position with the everting mattress suture technique.An abbott sizer was used in the surgery.On (b)(6) 2021, the patient presented for a follow-up and moderate aortic regurgitation (ar) was diagnosed.After this, on an unknown date, the patient complained of difficulty breathing.On (b)(6) 20201, the trifecta valve was explanted, replaced with a 19mm sjm regent heart valve w/flex cuff.Prior to explant, the device was found to be torn on the left coronary cusp (lcc) and the right coronary cusp (rcc) stent post side.The physician has suspected that shortage of the valve intensity might have been attributed to this issue.The device got damaged at the cuff part upon explant.The patient is stable.No additional information was provided.

Manufacturer Narrative

Explant was reported due to regurgitation and a leaflet tear was found at explant.The investigation found that leaflets 1 and 3 were torn.There was focal fibrous pannus on the outflow surface of leaflet 1 and the inflow surface of leaflet 2.A calcifications was found at the tear site in leaflet 3.No acute 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.The cause of the tears could not be conclusively determined; however, the tear noted in leaflet 3 was associated with calcifications and the fibrous pannus ingrowth noted on the outflow of leaflet 1 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, BRASIL LTDA.; rua professor jose vieira de mendonça 1301; engenho nogueira - belo horizonte - mg; belo horizonte 31310 -260; BR 31310-260
• Manufacturer (Section G): ST. JUDE MEDICAL, BRASIL LTDA.; rua professor jose vieira de mendonça 1301; engenho nogueira - belo horizonte - mg; belo horizonte 31310 -260; BR 31310-260
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 12741254
• MDR Text Key: 279782731
• Report Number: 3001883144-2021-00141
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 05414734052016
• UDI-Public: 05414734052016
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P100029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/02/2015
• Device Model Number: TF-19A
• Device Catalogue Number: TF-19A
• Device Lot Number: 4274093
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/27/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/03/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 48 KG