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

Model Number	TF-A
Medical Device Problem Codes	Degraded (1153); Incomplete Coaptation (2507)
Health Effect - Clinical Code	Aortic Valve Insufficiency/ Regurgitation (4450)
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.The explant date is on an unknown date in 2022, and the estimated date will be denoted as 1 jan 2022.
Event or Problem Description
It was reported that on (b)(6) 2013, a patient had a 25 mm trifecta valve replaced.In 2021, it was reported that the patient had a stroke.In 2022, an emergency valve replacement was conducted due to severe aortic regurgitation.It was noted that the valve had deteriorated severely.The current patient status is unknown.
Additional Manufacturer Narrative
An event of regurgitation and valve deterioration and explant of the valve was reported.A more comprehensive assessment, including histopathological examination of the valve tissue could not be performed as the device was not returned for analysis.However, based on the information received, the reported valve degeneration is consistent with structural valve deterioration (svd), 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.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) also could not be confirmed as the valve was not returned for histopathological examination.It was also reported that the valve had been implanted for nearly 9 years, which could have contributed to the valve deterioration.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 root cause of the reported event of regurgitation and valve deterioration could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• 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 #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: 14962547
• Report Number: 2135147-2022-00479
• Device Sequence Number: 5372370
• Product Code: LWR
• UDI-Device Identifier: 05414734052047
• UDI-Public: 05414734052047
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P100029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/24/2013
• Device Model Number: TF-A
• Device Catalogue Number: TF-25A
• Device Lot Number: 3546194
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/12/2022
• Supplement Date Received by Manufacturer: 07/23/2022
• Initial Report FDA Received Date: 07/08/2022
• Supplement Report FDA Received Date: 08/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2011
• 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: Hospitalization; Required Intervention
• Patient Sex: Male