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

Catalog Number UNK REGENT HEART VALVE

Device Problems Fracture (1260); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/15/2023

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2023, an unknown regent valve was chosen for implantation.After implant, when the valve was rotated it broke, resulting in one of the leaflets falling into the ventricle.The leaflet was retrieved and a replacement mechanical heart valve was implanted.

Manufacturer Narrative

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

Manufacturer Narrative

An event of leaflet detachment and fracture 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.Field indicated that the valve was rotated during implantation which could have contributed to the reported event.Based on available information and without the device to analyze, the root cause of the reported event could not be determined.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• 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: 18480273
• MDR Text Key: 332491240
• Report Number: 2135147-2024-00162
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK REGENT HEART VALVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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