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

Catalog Number	19AGFN-756
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2024
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.The additional regent valve described in b5, will be filed under a separate medwatch report.
Event or Problem Description
It was reported, that on (b)(6) 2024.A 19mm regent aortic mechanical heart valve (serial#: (b)(6)) was chosen for implantation.During implantation, while placing the valve, one of the leaflets detached and went inside the patient anatomy.The valve had been rotated with the valve rotator without resistance.The holder handle was fully inserted into the orifice at a 90 degree angle.The valve was in a closed position, when it was rotated and the leaflet dislodged.The regent valve was removed and the leaflet was recovered from the left atrium intact, by surgically opening the left atrium with echocardiographic guidance.A second 19mm regent aortic mechanical heart valve (serial#: (b)(6)), was then attempted to be implanted.While attempting to rotate the valve in closed position, both leaflets dislodged.The leaflets were removed from the patient successfully without unusual intervention.A third masters hp valve was implanted successfully.There were no patient consequences.The patient remained hemodynamically stable throughout the procedure.There was reportedly, a delay that resulted in no patient effects, as bypass time was extended 40-50 minutes.The patient was reported to be stable.
Event or Problem Description
It was reported that on 25 march 2024, a 19mm regent aortic mechanical heart valve (serial: (b)(6)) was chosen for implantation.During implantation, while placing the valve one of the leaflets detached and went inside the patient anatomy.The valve had been rotated with the valve rotator without resistance.The holder handle was fully inserted into the orifice at a 90 degree angle.The valve was in a closed position when it was rotated and the leaflet dislodged.The regent valve was removed and the leaflet was recovered from the left atrium intact by surgically opening the left atrium with echocardiographic guidance.A second 19mm regent aortic mechanical heart valve (serial: (b)(6)) was then attempted to be implanted.While attempting to rotate the valve in closed position, both leaflets dislodged.The leaflets were removed from the patient successfully without unusual intervention.A third masters hp valve was implanted successfully.There were no patient consequences.The patient remained hemodynamically stable throughout the procedure.There was reportedly a delay that resulted in no patient effects as bypass time was extended 40-50 minutes.The patient was reported to be stable.
Additional Manufacturer Narrative
An event of a leaflet dislodgement that required surgical intervention was reported.The device was returned to abbott for investigation, and one leaflet was observed to be dislodged while the other leaflet was properly inserted into the orifice.Microscopical examination found a crack at one of the pivot guards.The orifice wall contained a small chip.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 leaflet dislodgment could not be conclusively determined; however, the damage may have been caused by some external force applied to the valve, which overstressed the carbon material.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• 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: 19259938
• Report Number: 2135147-2024-02027
• Device Sequence Number: 2582398
• Product Code: LWQ
• UDI-Device Identifier: 05414734005852
• UDI-Public: (01)05414734005852(17)280419(10)C00011257
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2024

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 19AGFN-756
• Device Lot Number: C00011257
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/12/2024
• Supplement Date Received by Manufacturer: 05/08/2024
• Initial Report FDA Received Date: 05/07/2024
• Supplement Report FDA Received Date: 05/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/21/2023
• 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: Required Intervention
• Patient Sex: Unknown