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

Model Number	TF-A
Medical Device Problem Codes	Calcified (1077); Degraded (1153); Intravalvular regurgitation (4068)
Health Effect - Clinical Codes	Stroke/CVA (1770); Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	06/03/2022
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.User facility / maude report number: mw5110544na.
Event or Problem Description
It was reported that on an unknown date in (b)(6) 2013, a 25mm trifecta valve was successfully implanted.On an unknown date in (b)(6) 2021, the patient experienced a stroke and was placed on eliquis.In (b)(6) 2022, the patient underwent emergency valve replacement due to severe aortic valve regurgitation and valve deterioration.Upon explant, there was calcification noted on the device.The patient status was reported as unknown.User facility medwatch report received that states a 25mm trifecta valve was implanted in (b)(6) 2013.Sometime in (b)(6) 2022, severe aortic valve regurgitation was diagnosed and required emergency valve replacement.The surgeon indicated valve deteriorated with much calcification.
Additional Manufacturer Narrative
Explant due to severe aortic valve regurgitation and valve deterioration was reported.A returned device assessment and histopathological examination could not be performed as the device remains was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.H6.Medical device problem code: removed 1153 degraded, added: 4068 central regurgitation and 1077 calcified.
Event or Problem Description
N/a.

• 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: 15651197
• Report Number: 2135147-2022-01723
• Device Sequence Number: 6240630
• Product Code: LWR
• UDI-Device Identifier: 05414734052047
• UDI-Public: 05414734052047
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P100029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2022

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 Model Number: TF-A
• Device Catalogue Number: TF-25A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/30/2022
• Supplement Date Received by Manufacturer: 12/07/2022
• Initial Report FDA Received Date: 10/21/2022
• Supplement Report FDA Received Date: 12/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Unknown