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

Model Number TF-21A

Device Problems Material Separation (1562); Material Split, Cut or Torn (4008)

Patient Problem Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 09/03/2022

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2018, a 21mm trifecta valve was successfully implanted.On (b)(6) 2022, during a routine check, severe aortic regurgitation was detected.The patient's gradient during the preoperative echo was 45mmhg.On imaging, the physician observed dehiscence of the tissue between the non-coronary and left coronary artery, near the valve post of the trifecta valve.The valve was emergently explanted on (b)(6) 2022 and lasix and warfarin were administered.A 21mm non-abbott valve was then implanted as a replacement.The gradient following the replacement valve was implanted was read at 15mmhg.The patient was reported as stable.

Manufacturer Narrative

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

Manufacturer Narrative

An event of regurgitation and explant of the valve was reported.The device history record was also reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.A more comprehensive assessment, including histopathological examination of the valve tissue could not be performed as the device was not returned for analysis.However, four images were received from the field.Three of the photos appeared to show the valve still implanted, and a tear appeared to be present at one of the stent posts.The last appeared to show an explanted trifecta valve where two of the leaflets appeared prolapsed, consistent with a tear at a stent post.A ring of white tissue was also present in the image, but was not clear if it had come from the valve.Based on the information received, the reported leaflet tear is consistent with structural valve deterioration (svd), specifically non-calcific leaflet tear, which is a well-known complication of tissue heart valve replacement surgery.A variety of factors may contribute to svd, including patient, biological, and implant related factors.No implant related factors could be confirmed from the information received from the field as information related to implant procedure was not provided.However, a images provided from the field indicated a leaflet tear but did not appear to show calcification, thereby ruling out another type of svd, fibrocalcific svd.Biological factors which can result in tissue degeneration such as calcification (from patient conditions predisposing to elevated calcium like renal disease etc.) or thinning of the prosthetic leaflet tissue (predisposing to leaflet tears) could not be confirmed as the valve was not returned for histopathological examination.There is no indication of a product quality issue with regards to manufacture, design, or labeling.H6 medical device problem code: code 1562 removed.

• 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: 15936765
• MDR Text Key: 305042434
• Report Number: 2135147-2022-02374
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 02/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/13/2022
• Device Model Number: TF-21A
• Device Catalogue Number: TF-21A
• Device Lot Number: BR00015453
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2018
• 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: 61 YR
• Patient Sex: Male