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

Catalog Number	25AGFN-756
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2008
Type of Reportable Event	Death
Event or Problem Description
It was reported that on (b)(6) 2008, a 25mm sjm regent heart valve w/ flex cuff was implanted in the patient.On (b)(6) 2024, it was reported that the patient passed away.
Event or Problem Description
It was reported that on (b)(6) 2008, a 25mm sjm regent heart valve w/ flex cuff was implanted in the patient.On (b)(6) 2024, it was reported that the patient passed away; however, there was no allegation of malfunction against the valve.In addition, there is no indication the device caused or contributed to the patient death.Subsequent to the previously filed report, additional information was received as there was no allegation of malfunction against the valve.In addition, there is no indication the device caused or contributed to the patient death.
Additional Manufacturer Narrative
H6 health effect - clinical code 4480 was removed.H6 health effect - impact code 1802 was removed.H6 medical device problem code 2993 was removed.Upon further review, this event should not have been submitted as a medical device report as there is no allegation of device malfunction against the implanted valve and/or implant procedure.In addition, the patient passed away; however, they did not experience any adverse consequences related to the event and/or procedure.An event of 25 mm regent heart valve w/ flex cuff was implanted and 16 years from implant patient death was reported.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.Per the information available abbott cannot further speculate on why the reported death occurred.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.From medical review: "cause of death is unknown.It was noted that the valve implanted had not failed.The patient was cremated and the valve was also cremated.No allegations against the implanted valve and/or the implant procedure.If additional information is received the event will be reassessed.".

• 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: 19897756
• Report Number: 2135147-2024-03777
• Device Sequence Number: 6821266
• Product Code: LWQ
• UDI-Device Identifier: 05414734006262
• UDI-Public: (01)05414734006262(17)121201(10)0002635983
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/01/2012
• Device Catalogue Number: 25AGFN-756
• Device Lot Number: 0002635983
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/10/2024
• Supplement Date Received by Manufacturer: 09/11/2024
• Initial Report FDA Received Date: 08/02/2024
• Supplement Report FDA Received Date: 09/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/11/2007
• 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 Age: 56 YR
• Patient Sex: Male