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

Catalog Number 19AGFN-756

Device Problem Physical Resistance/Sticking (4012)

Patient Problem Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 08/29/2023

Event Type  malfunction  

Event Description

It was reported that on (b)(6) 2023, a 19mm sjm regent heart valve w/ flex cuff was implanted.After the valve was sutured onto the annulus, spontaneous circulation was attempted to be returned as the pump was off.Regurgitation was confirmed by tee at the same time and it was also confirmed asynchronized leaflet motion.The pump was attached to the patient and obtained cardiac arrest again, then the aorta was incised.After that, the physician rotated the leaflet and confirmed those normal movement.The procedure was completed without further issue.

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that on (b)(6) 2023, a 19mm sjm regent heart valve w/ flex cuff was implanted.After the valve was sutured onto the annulus, spontaneous circulation was attempted to be returned as the pump was off.Regurgitation was confirmed by tee at the same time and it was also confirmed asynchronized leaflet motion.The pump was attached to the patient and obtained cardiac arrest again, then the aorta was incised.After that, the physician rotated the leaflet and confirmed those normal movement.The procedure was completed without further issue.Subsequent to the previously filed report, additional information was received that the correct implant date was (b)(6) 2023.It was noted that a non-abbott device (cor-knot) was used to suture the 19mm sjm regent heart valve with flex cuff instead of manual suturing.It was also noted that spontaneous circulation was attempted to be returned via turning on the pump.It was confirmed that the patient was taken off bypass and placed back on bypass due to this event.It was noted via transesophageal echocardiogram, that there was aortic regurgitation and asynchronized valve leaflet motion.The decision was made to rotate the valve until normal leaflet function was confirmed.The procedure was completed without further complication and the 19mm sjm regent heart valve with flex cuff remains implanted.There were no adverse patient consequences reported.It was noted that the non-abbott cor-knot device used to in the procedure might have narrowed the annulus compared to manually suturing the valve.The non-abbott device may then have caused pressure to the orifice ring of the valve and interfered with the leaflets movement, but this was not confirmed.It was also confirmed that the patient did not suffer a cardiac arrest.

Manufacturer Narrative

An event of asynchronous leaflet motion was reported.A returned device assessment could not be performed as the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.Information from the field indicated that the physician decided to rotate the valve until normal leaflet function was confirmed and that a non-abbott device (cor-knot) was used to suture the valve to the annulus.Based on the information received, the cause of the reported incident could not be conclusively determined; however, the physician presumed because the cor-knot was used to suture the valve on to the annulus, the annulus might have been more narrowed than being sutured manually thus affecting leaflet movement.There is no indication of a product quality issue with respect to the labeling design or manufacturing of the device.

• Brand Name: REGENT HEART VALVE WITH FLEX CUFF
• Type of Device: 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: 17940912
• MDR Text Key: 325748973
• Report Number: 2135147-2023-04526
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734005852
• UDI-Public: 05414734005852
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 19AGFN-756
• Device Lot Number: C00004096
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention