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

Catalog Number	TF-21A
Medical Device Problem Code	Device Stenosis (4066)
Health Effect - Clinical Codes	Aortic Valve Stenosis (1717); Dyspnea (1816); Heart Failure/Congestive Heart Failure (4446)
Date of Event	08/23/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on (b)(6) 2019, a 21mm sjm trifecta valve was implanted in the aortic position, and the post-operative mean pressure gradient (mpg) was 10mmhg.On (b)(6) 2022, the patient was hospitalized for exertional dyspnea and treated conservatively for acute coronary syndrome (acs) and acute decompensated heart failure (adhf).On (b)(6) 2022, the patient was admitted to a different hospital for further management.When a transesophageal echocardiogram (tee) was performed, the peak pressure gradient was 60mmhg and the mean pressure gradient was 43mmhg.On echo, the peak pressure gradient was 62mmhg and the mean pressure gradient was 39mmhg.The patient was not willing to undergo redo surgery.The patient was discharged.It was noted that once the patient comes back, they would plan for replacement.Subsequent to the previously filed report 3005334138-2022-00241, additional information was received that on 23 august 2023, the 21mm trifecta valve was explanted and replaced with a 21mm epic valve.
Event or Problem Description
It was reported that on (b)(6) 2019, a 21mm sjm trifecta valve was implanted in the aortic position, and the post-operative mean pressure gradient (mpg) was 10mmhg.On (b)(6) 2022, the patient was hospitalized for exertional dyspnea and treated conservatively for acute coronary syndrome (acs) and acute decompensated heart failure (adhf).On (b)(6) 2022, the patient was admitted to a different hospital for further management.When a transesophageal echocardiogram (tee) was performed, the peak pressure gradient was 60mmhg and the mean pressure gradient was 43mmhg.On echo, the peak pressure gradient was 62mmhg and the mean pressure gradient was 39mmhg.The patient was not willing to undergo redo surgery.The patient was discharged.It was noted that once the patient comes back, they would plan for replacement.Subsequent to the previously filed report, additional information was received that closest to the explant procedure, the patient had a peak pressure gradient of 73mmhg and mean pressure gradient of 46mmhg, so the decision was made to replace the device.The patient was also experiencing aortic regurgitation.On (b)(6) 2023, the 21mm trifecta valve was emergently explanted and replaced with a 21mm epic plus valve.On the explanted device, there was calcification and a tear.The patient was reported to be discharged.
Additional Manufacturer Narrative
An event of exertional dyspnea and aortic regurgitation after two years of implant was reported.It was also reported that the device was explanted and explanted device was noted to have calcification and a tear.A more comprehensive assessment, including histopathological examination of the valve tissue could not be performed as the device was not returned for analysis.The device history record was also reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.Based on the available information the cause of the tear could not be conclusively determined; however, the leaflet tear could have been associated with reported calcification.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• Brand Name: SJM TRIFECTA VALVE
• Common Device Name: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL LTDA. REG#3001883144; 1301rua profvieira demendonça; bairro engenho nogueira 31.31 0-26; BR 31.310-260
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 17769836
• Report Number: 2135147-2023-04054
• Device Sequence Number: 7192843
• Product Code: LWR
• UDI-Device Identifier: 05414734052023
• UDI-Public: 05414734052023
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P100029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/21/2022
• Device Catalogue Number: TF-21A
• Device Lot Number: BR00015864
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/24/2023
• Supplement Date Received by Manufacturer: 09/22/2023
• Initial Report FDA Received Date: 09/18/2023
• Supplement Report FDA Received Date: 10/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 61 YR
• Patient Sex: Male