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

Catalog Number 21AGN-751

Device Problem Incomplete Coaptation (2507)

Patient Problem Insufficient Information (4580)

Event Date 03/28/2024

Event Type  malfunction  

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) 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 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.

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
• 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: 19182472
• MDR Text Key: 341122872
• Report Number: 2135147-2024-01844
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734005982
• UDI-Public: (01)05414734005982(17)281022(10)C00016526
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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
• Report Date: 04/25/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 21AGN-751
• Device Lot Number: C00016526
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/02/2024
• Initial Date FDA Received: 04/25/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/24/2023
• 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