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

Catalog Number	19AGN-751
Medical Device Problem Code	Incomplete Coaptation (2507)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is expected to be returned for evaluation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on 22 august 2024, a 19mm sjm regent heart valve was chosen for a aortic valve replacement (avr) procedure.During procedure, after root enlargement the physician implanted the valve.Approximately thirty to forty minutes after the procedure, they found that because of hypertrophic lv and valve thickness leaflet motion was compromised.The valve was explanted and a new 17mm sjm regent heart valve was implanted.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.The patient was reported discharged.
Additional Manufacturer Narrative
An event of incomplete coaptation was reported.A return device assessment could not be performed since device was not returned for analysis.It was indicated that the approximately thirty to forty minutes after the procedure, they found that because of hypertrophic lv and valve thickness leaflet motion was compromised.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.
Event or Problem Description
N/a.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
An event of leaflet incomplete coaptation was reported.The device was returned to abbott for investigation and found that both the leaflets were intact and mobile.The valve was able to be rotated freely.There were no visible evidence of surface damage or anomalies.Hydrodynamic testing upon return to abbott indicated the valve functioned normally.This test ensures proper leaflet coaptation and hemodynamic performance.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 received, the cause of the reported incomplete coaptation could not be conclusively determined.The reported surgical intervention was a result of case-specific circumstance as the device was explanted and a replacement was implanted.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• Brand Name: REGENT HEART VALVE
• Common Device Name: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL REG# 2648612; lot 20 b st caguas; caguas 00725 ; * 00725
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 20224212
• Report Number: 2135147-2024-04520
• Device Sequence Number: 3505410
• Product Code: LWQ
• UDI-Device Identifier: 05414734005869
• UDI-Public: (01)05414734005869(17)290124(10)C00018385
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/31/2024

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: 19AGN-751
• Device Lot Number: C00018385
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/22/2024
• Supplement Date Received by Manufacturer: 10/11/2024; 12/21/2024
• Initial Report FDA Received Date: 09/16/2024
• Supplement Report FDA Received Date: 10/24/2024; 12/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/26/2024
• 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