MAUDE Adverse Event Report: ABBOTT MEDICAL MASTERS SERIES VALVE EXPANDED CUFF; HEART-VALVE, MECHANICAL

Catalog Number	23MECJ-502
Medical Device Problem Code	Incomplete Coaptation (2507)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2024, a 23mm mitral masters valve was selected for implant.The valve was sized with a 905 abbott sizer set.During device preparation, the leaflets were tested and moving normally.After implant, the valve leaflets were tested with a tester and the valve did not close completely; the leaflets did not have difficulty opening completely.Therefore, the valve was explanted; the patient had not been closed prior to explanting the valve.Upon explant, the leaflet was not tested again; a new 25mm mitral masters valve was successfully implanted.The patient's antithrombotic regimen consisted of heparin; the patient's latest international normalized ratio (inr) and inr history are unknown.The patient was reported to be in stable condition.
Additional Manufacturer Narrative
An event of difficulty in opening and closing the valve leaflets was reported.It was indicated that the leaflets were tested and moving normally prior to procedure.After implant, the valve leaflets were tested with a tester and the valve did not close completely.A returned device assessment to rule out any device related problem 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.There is no indication of a product quality issue with respect to the labeling design or manufacturing of the device.

• Brand Name: MASTERS SERIES VALVE EXPANDED 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: 19784680
• Report Number: 2135147-2024-03496
• Device Sequence Number: 12854917
• Product Code: LWQ
• UDI-Device Identifier: 05414734006170
• UDI-Public: (01)05414734006170(17)240701(10)7074783
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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
• Report Date (Section B): 07/19/2024

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: 07/01/2024
• Device Catalogue Number: 23MECJ-502
• Device Lot Number: 7074783
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/27/2024
• Initial Report FDA Received Date: 07/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/03/2019
• 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 Age: 39 YR
• Patient Sex: Female
• Patient Weight: 44 KG