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

Catalog Number 19AGFN-756

Device Problem Central Regurgitation (4068)

Patient Problem Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 06/21/2023

Event Type  malfunction  

Event Description

It was reported that on (b)(6) 2023, a 19mm sjm regent heart valve with flex cuff was chosen for implant for an aortic valve replacement.During procedure, a sizer was used to choose a 19mm valve.The valve was implanted, but regurgitation was detected prior to chest closure.The regurgitation was noted at the non-coronary cusp and right coronary cusp commissures.The valve was removed and replaced with a 21mm sjm regent heart valve with flex cuff.The patient remained on bypass during this event.There was no clinically significant delay in procedure and no adverse patient effects.The patient was reported to be discharged.

Manufacturer Narrative

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

Manufacturer Narrative

An event if regurgitation was reported.A returned device assessment could not be performed as the device was not returned for analysis.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 incident could not be conclusively determined.However, it was noted that there was no allegation of malfunction against the abbott device or procedure.

• 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: 17399275
• MDR Text Key: 320143449
• Report Number: 2135147-2023-03207
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734005852
• UDI-Public: 05414734005852
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 08/04/2023

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: 19AGFN-756
• Device Lot Number: 7744103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/03/2023
• Initial Date FDA Received: 07/26/2023
• Supplement Dates Manufacturer Received: 07/27/2023
• Supplement Dates FDA Received: 08/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2020
• 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