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

Model Number	29MECJ-502
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2023
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 29mm sjm masters series valve expanded cuff was chosen for implant.While attempting to implant the valve, the leaflet of the valve was broken.A new 29mm epic valve was then successfully implanted as a replacement.The patient was reported as stable.
Additional Manufacturer Narrative
An event of a dislodged leaflet was confirmed.The device was returned to abbott for investigation, and one leaflet was dislodged and fractured while the other leaflet was properly inserted into the orifice.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and that the product met all defined manufacturing specifications.How or when the damage occurred could not be conclusively determined.However, all fractured pieces were returned, and the damage may have been caused by some external force applied to the valve, which overstressed the carbon material.

• 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 MN 00725 ; * 00725
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 16594701
• Report Number: 2135147-2023-01299
• Device Sequence Number: 14161692
• Product Code: LWQ
• UDI-Device Identifier: 05414734006545
• UDI-Public: 05414734006545
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• 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): 05/22/2023

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: 09/19/2024
• Device Model Number: 29MECJ-502
• Device Catalogue Number: 29MECJ-502
• Device Lot Number: 7191276
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/27/2023
• Supplement Date Received by Manufacturer: 04/30/2023
• Initial Report FDA Received Date: 03/22/2023
• Supplement Report FDA Received Date: 05/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/21/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown