MAUDE Adverse Event Report: ABBOTT MEDICAL REGENT HEART VALVE WITH FLEX CUFF; HEART-VALVE, MECHANICAL

Model Number	25AGFN-756
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/02/2022
Type of Reportable Event	Death
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) 2008, a 25mm regent aortic mhv, flex c uff was successfully implanted.On (b)(6) 2022 it was reported that the patient passed away due to the heart valve.The cause of the death is unknown.
Additional Manufacturer Narrative
An event of patient death about 14 years after the device was implanted was reported.Information from the field indicated the death was related to the valve and additional information was requested but could not be received.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Based on the information provided, the cause of the reported event could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• Brand Name: REGENT HEART VALVE WITH FLEX CUFF
• Common Device Name: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, INC. REG#2648612; 20 b st caguas west park; caguas 00725 ; * 00725
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 15669464
• Report Number: 2135147-2022-01784
• Device Sequence Number: 6368993
• Product Code: LWQ
• UDI-Device Identifier: 05414734006262
• UDI-Public: 05414734006262
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 25AGFN-756
• Device Catalogue Number: 25AGFN-756
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/05/2022
• Supplement Date Received by Manufacturer: 01/12/2023
• Initial Report FDA Received Date: 10/25/2022
• Supplement Report FDA Received Date: 01/17/2023
• 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: Death
• Patient Sex: Unknown