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

Catalog Number	21AGFN-756
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2023
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) 2023, a 21mm regent aortic mhv,flex cuff was selected for an implant.The physician rotated the valve with the valve rotator and the holder handle fully inserted into the orifice at a 90 degree angle.During the procedure, the physician discovered that one leaflet was detached and was removed from the patient.A 19mm regent aortic mhv,flex cuff was selected and implanted as a replacement.The patient is stable.
Additional Manufacturer Narrative
An event of one leaflet detached during procedure 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.Two images from field appeared to show a mechanical valve with one leaflet dislodged and placed on the side.The sewing cuff appeared red in color.Based on the information received, the potential cause of the reported incident could be related to oversizing, given that the procedure was successfully completed with a smaller valve.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
Event or Problem Description
It was reported that on (b)(6) 2023, a 21mm regent aortic mhv,flex cuff was selected for an implant.The physician rotated the valve with the valve rotator and the holder handle fully inserted into the orifice at a 90 degree angle.During the procedure, the physician discovered that one leaflet was detached and was removed from the patient.A 19mm regent aortic mhv,flex cuff was selected and implanted as a replacement.The patient is stable.

• Brand Name: REGENT HEART VALVE WITH FLEX CUFF
• 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: 17976640
• Report Number: 2135147-2023-04594
• Device Sequence Number: 19700590
• Product Code: LWQ
• UDI-Device Identifier: 05414734005975
• UDI-Public: 05414734005975
• Combination Product (Y/N): N
• Initial Reporter Country: LE
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 12/11/2023

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
• Operator of Device: Health Professional
• Device Catalogue Number: 21AGFN-756
• Device Lot Number: C00011760
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/28/2023
• Supplement Date Received by Manufacturer: 11/16/2023
• Initial Report FDA Received Date: 10/20/2023
• Supplement Report FDA Received Date: 12/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2023
• 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