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

Catalog Number	TF-29A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Heart Failure/Congestive Heart Failure (4446)
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
User facility medwatch report mw5158559 received that states ¿my father received an abbott trifecta tissue heart valve (model tf-29a) in (b)(6) 2016.He discovered that the device was recalled on 06/21/2024 after worsening health condition that lead to eventual hospitalization on (b)(6) 2024 and death on (b)(6) 2024 prior to a surgery to replace the defective heart valve." it was reported that on an unknown date and year, a 29mm trifecta valve was implanted in a patient.On an unknown date and year, the patient had worsening heart failure and hospitalized.The patient was hospitalized and passed away prior to surgical intervention.The cause of death is unknown.
Event or Problem Description
User facility medwatch report mw5158559 received that states ¿my father received an abbott trifecta tissue heart valve (model tf-29a) in (b)(6) 2016.He discovered that the device was recalled on 06/21/2024 after worsening health condition that lead to eventual hospitalization on (b)(6) 2024 and death on (b)(6) 2024 prior to a surgery to replace the defective heart valve." it was reported that on an unknown date and year, a 29mm trifecta valve was implanted in a patient.On an unknown date and year, the patient had worsening heart failure and hospitalized.The patient was hospitalized and passed away prior to surgical intervention.The cause of death is unknown, no additional information was provided.The device was recalled on (b)(6) 2024.
Additional Manufacturer Narrative
An event of patient death after implant was reported.It was indicated that the patient had worsening heart failure and hospitalized.The patient was hospitalized and passed away prior to surgical intervention.A more comprehensive assessment could not be performed as no other information was provided.A returned device assessment could not be performed as the device remains implanted and was not returned for analysis.Based on the information received, the root cause of the reported incident could not be conclusively determined.From on medical review: " med watch received from a patient's son related to a trifecta device that was implanted.Narrative indicates that the patient experienced worsening health conditions that lead to hospitalization and death prior to a replacement surgery for the trifecta valve.At this time there is no additional information, therefore at this time a review cannot be completed.".

• 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: 20257203
• Report Number: 2135147-2024-04603
• Device Sequence Number: 12648734
• Product Code: LWR
• UDI-Device Identifier: 05414734052061
• UDI-Public: 05414734052061
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P100029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2024

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 Catalogue Number: TF-29A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/26/2024
• Supplement Date Received by Manufacturer: 10/03/2024
• Initial Report FDA Received Date: 09/19/2024
• Supplement Report FDA Received Date: 10/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White