MAUDE Adverse Event Report: ABBOTT MEDICAL SJM TRIFECTA VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number TF-A

Device Problems Material Split, Cut or Torn (4008); Central Regurgitation (4068)

Patient Problems Dyspnea (1816); Low Blood Pressure/ Hypotension (1914); Heart Failure/Congestive Heart Failure (4446); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 05/01/2022

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2019, a 23mm trifecta valve was implanted in the patient.The diameter of the patient's annulus was noted as 27mm.On an unknown day in may 2022, the patient returned to the hospital for a follow up appointment and it was noted via echocardiogram that the patient had severe aortic regurgitation.On an unknown day in july 2022, the patient was hospitalized due to acute heart failure but was discharged from the hospital two weeks later.On (b)(6) 2022, the acute heart failure occurred again and the decision was made to explant and replace the 23mm trifecta valve with a 21mm epic supra valve.It was noted during the explant procedure that there was a torn leaflet on the 23mm trifecta valve and no observable pannus.The patient was stable at the time of report.

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

Explant due to regurgitation and heart failure was reported.The investigation found that leaflet 2 and 3 were torn.No inflammations 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 of 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.Histological evaluation revealed degenerative changes at one of the tear sites, which could have contributed to the tear formation.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

Event Description

It was reported that on (b)(6) 2019, a 23mm trifecta valve was implanted in the patient.The diameter on the patient annulus was noted as being 27mm.On an unknown day in (b)(6) 2022, the patient returned to the hospital for a follow up appointment and it was noted via echocardiogram that the patient had severe aortic regurgitation.On an unknown day in (b)(6) 2022, the patient was hospitalized due to acute heart failure but was discharged from the hospital two weeks later.On (b)(6) 2022, the acute heart failure occurred again and the decision was made to explant and replace the 23mm trifecta valve with a 21mm epic supra valve.It was noted during the explant procedure that there was a torn leaflet on the 23mm trifecta valve and no observable pannus.The patient was stable at the time of report.Subsequent to the previously filed report, additional information was received that the patient experienced a drop in blood pressure, heart palpitations, and shortness of breath due to the improperness of the 23mm trifecta valve.The reason for having selected a smaller 21mm epic supra valve as a replacement device was due to the sizer set of the epic supra valve being different than the sizer set for the 23mm trifecta valve.The 23mm trifecta valve and 21mm epic supra valve had been sized according the instructions for use.The explant and replacement of the 23mm trifecta valve was done emergently to prevent permanent impairment or death.

• Brand Name: SJM TRIFECTA VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL #3014918977; edificio #44 calle 0, ave. 2; el coyol alajuela 1897- 4050; CS 1897-4050
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 15721387
• MDR Text Key: 303036774
• Report Number: 2135147-2022-01922
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 05414734052030
• UDI-Public: 05414734052030
• 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: 01/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/04/2020
• Device Model Number: TF-A
• Device Catalogue Number: TF-23A
• Device Lot Number: 6594568
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/05/2016
• 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; Hospitalization
• Patient Age: 92 YR
• Patient Sex: Male