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

Model Number TF-21A

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 11/21/2022

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2014, a 21mm sjm trifecta valve was implanted in aortic position.In july 2022, the patient presented to the hospital with dyspnea on exertion.Echocardiogram was performed, which showed aortic regurgitation; leaflet tear was suspected.A diuretic agent was prescribed to control cardiac insufficiency.However, the symptom did not improve.Therefore, redo aortic valve replacement was selected.On (b)(6) 2022, the trifecta valve was explanted and a new 21mm epic supra valve was implanted.Upon explant, the leaflets of the commissures of the left coronary cusp (lcc) of the trifecta valve were torn.The leaflet had not become hardened and no pannus was observed over the leaflets.The patient was reported to be in stable condition.

Manufacturer Narrative

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

Manufacturer Narrative

Explant due to aortic regurgitation, dyspnea and suspected leaflet tear was reported.The investigation found there was fibrous thickening on all leaflets.All leaflets were noted to be torn.There was circumferential fibrous pannus ingrowth on the inflow surface and on the outflow surfaces of leaflets 1 and 3.There was calcification on leaflet 1.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 leaflet tears could not be conclusively determined; however, the degenerative changes at the tear site noted to the tissue could have contributed to the tear formation.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; in addition, tear in leaflet 2 was associated with calcifications.The noted tears could have contributed to the reported regurgitation.

• 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: 15974593
• MDR Text Key: 305412149
• Report Number: 2135147-2022-02531
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 05414734052023
• UDI-Public: 05414734052023
• 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: 12/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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?: 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: 08/28/2013
• 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: 78 YR
• Patient Sex: Male