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

Catalog Number	23AGN-751
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2022
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) 2022, a 23mm sjm regent heart valve was chosen for implant.After the valve was implanted, it was found the valve could not be rotated.It was reported the holder handle was fully inserted into the orifice at 90 degree angle and no other tool was used to position or rotate the valve.A decision was made to explant the device and replace with a 21mm sjm regent heart valve.The replacement valve was successfully implanted with no adverse patient consequences.There was no clinically significant delay in the procedure due to this event.The patient status was reported as stable.
Additional Manufacturer Narrative
An event of difficulty rotating the valve after it was implanted was reported.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.A returned device assessment could not be performed as the device was not returned for analysis.Information from the field indicated that a smaller valve was successfully implanted.Oversizing of the valve can contribute to difficulty rotating the valve after implant, which could have contributed to the reported event, however as the valve was not received for examination the cause of the difficulty rotating the valve could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• Brand Name: REGENT HEART VALVE
• 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: 17574713
• Report Number: 2135147-2023-03605
• Device Sequence Number: 9006376
• Product Code: LWQ
• UDI-Device Identifier: 05414734006101
• UDI-Public: 05414734006101
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 09/20/2023

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 Expiration Date: 03/30/2025
• Device Catalogue Number: 23AGN-751
• Device Lot Number: 7466610
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/26/2023
• Supplement Date Received by Manufacturer: 08/28/2023
• Initial Report FDA Received Date: 08/18/2023
• Supplement Report FDA Received Date: 09/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2020
• 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