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

Model Number 23AGFN-756

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 07/14/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It as reported that on (b)(6) 2022, a 23mm sjm regent heart valve with flex cuff was selected for procedure.It was noted that during procedure a leaflet of the regent valve become dislodged.The decision was made to replace the 23mm sjm regent heart valve with flex cuff with another one of the same size.However, it was noted that there was a 60 minute delay in procedure because the replacement valve had to be delivered from a different hospital.The patient was discharged at the time of report.

Manufacturer Narrative

An event of a dislodged leaflet was confirmed.One leaflet was unfractured and dislodged from the orifice.No other damages were noted on the valve.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The root cause of the leaflet dislodgement could not be conclusively determined.

• Brand Name: REGENT HEART VALVE WITH FLEX CUFF
• 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: 15298682
• MDR Text Key: 298666873
• Report Number: 2135147-2022-00916
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734006095
• UDI-Public: 05414734006095
• Combination Product (y/n): N
• Reporter Country Code: NZ
• 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,Followup
• Report Date: 11/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 23AGFN-756
• Device Catalogue Number: 23AGFN-756
• Device Lot Number: 7624233
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/13/2020
• 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): Other
• Patient Age: 54 YR
• Patient Sex: Male