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

Catalog Number	21AGN-751
Medical Device Problem Codes	Fracture (1260); Incomplete Coaptation (2507); Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2024
Type of Reportable Event	Malfunction
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) 2024, a 21mm regent aortic valve was chosen for implantation.At an unknown point during the procedure, the leaflets were not functioning properly.There were no reported patient effects.
Event or Problem Description
Subsequent to the previously filed report, additional information was received it was reported that on (b)(6) 2024, a 21mm regent aortic valve was chosen for implantation.During implantation, one of the leaflets was observed to be fractured.A replacement 21mm regent valve was implanted to complete the procedure.There were no reported patient effects or clinically significant delay.
Additional Manufacturer Narrative
H6 health effect - clinical code 4480 was removed.H6 health effect - impact code 4648 was removed.H6 medical device problem codes 2507 was removed.An event of leaflet fracture during implantation was reported.The possible causes of the reported event include an external force applied to the valve leaflets that may cause structural damage, the use of a hard or rigid instruments to test leaflet mobility and oversizing of the valve.Information from the field did not indicate whether any instruments came into contact with the valve during the procedure or if the valve was oversized.The device was returned to abbott for analysis and the investigation found that one leaflet was intact in the orifice and the other was received dislodged and fractured.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 potential cause of the reported incident could not be conclusively determined.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): 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: 19182472
• Report Number: 2135147-2024-01844
• Device Sequence Number: 15261838
• Product Code: LWQ
• UDI-Device Identifier: 05414734005982
• UDI-Public: (01)05414734005982(17)281022(10)C00016526
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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
• Report Date (Section B): 06/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 21AGN-751
• Device Lot Number: C00016526
• 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: 04/02/2024
• Supplement Date Received by Manufacturer: 05/20/2024
• Initial Report FDA Received Date: 04/25/2024
• Supplement Report FDA Received Date: 06/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2023
• 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
• Patient Sex: Unknown