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

Catalog Number	25AGFN-756
Medical Device Problem Code	Device Stenosis (4066)
Health Effect - Clinical Codes	Aortic Valve Stenosis (1717); Pneumonia (2011); Heart Failure/Congestive Heart Failure (4446)
Date of Event	08/11/2023
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
It was reported that on (b)(6) 2023, a 25mm sjm regent heart valve with flex cuff was chosen for implant for an aortic valve replacement.At the time of device preparation, the leaflets were moving normally when tested using a blue leaflet tester.After the device was implanted and the patient was removed from bypass, it was noted that the aortic valvular gradient was 40mmhg.On transesophageal echocardiogram (tee), both leaflets appeared to be functioning.The patient was placed on bypass again, and the valve was explanted and replaced with a 23mm non-abbott valve.Following the procedure, the patient had mild right ventricular dysfunction and pneumonia, and the hospitalization was extended.The patient status was stable.
Additional Manufacturer Narrative
An event of a valve not functioning as intended was reported.One video was received from the field appearing to show the testing of the valve leaflets.The valve was returned to abbott for analysis and the investigation found that both leaflets were able to fully open and close with no resistance occurring.Leaflet function was considered normal with both leaflets opening while having no asynchronous motion or leaflet malfunction.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.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.
Event or Problem Description
It was reported that on (b)(6) 2023, a 25mm sjm regent heart valve with flex cuff was chosen for implant for an aortic valve replacement.At the time of device preparation, the leaflets were moving normally when tested using a blue leaflet tester.After the device was implanted and the patient was removed from bypass, it was noted that the aortic valvular gradient was 40mmhg.On transesophageal echocardiogram (tee), both leaflets appeared to be functioning.The patient was placed on bypass again, and the valve was explanted and replaced with a 23mm non-abbott valve.After the valve was explanted, the leaflet function was tested again.It was noted that one of the leaflets had resistance with movement.Following the procedure, the patient had mild right ventricular dysfunction and pneumonia, and the hospitalization was extended.The patient status was stable.

• 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: 17685988
• Report Number: 2135147-2023-03863
• Device Sequence Number: 16789951
• Product Code: LWQ
• UDI-Device Identifier: 05414734006262
• UDI-Public: 05414734006262
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 10/31/2023

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 Catalogue Number: 25AGFN-756
• Device Lot Number: 31387574
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/11/2023
• Supplement Date Received by Manufacturer: 10/24/2023
• Initial Report FDA Received Date: 09/05/2023
• Supplement Report FDA Received Date: 10/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2023
• 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 Age: 57 YR
• Patient Sex: Male