MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. SJM MASTERS SERIES VALVE EXPANDED CUFF; HEART-VALVE, MECHANICAL

Model Number	21AECJ-502
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported, a 21mm sjm masters series valve expanded cuff was chosen for procedure.During the procedure while the user was positioning the device and rotated the valve, it was reported that the user applied increased tension to the valve as the it was not rotating properly and the leaflet broke.The device was removed and exchanged with a new 21mm sjm masters series valve expanded cuff.No additional information has been provided.The event did cause a reported extra 45 minutes on cardiopulmonary bypass and was stable throughout the procedure.No additional information has been provided.
Additional Manufacturer Narrative
The reported event of a "broken" leaflet was confirmed.Both leaflets was dislodged from the orifice and returned with the valve.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The cause of the leaflet dislodgment could not be conclusively determined, however information from the field indicated that the user applied additional tension to the valve, which could have contributed to the dislodged leaflets.

• Brand Name: SJM MASTERS SERIES VALVE EXPANDED CUFF
• Common Device Name: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 177 east county road b; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 177 east county road b; st. paul MN 55117
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 13587924
• Report Number: 3005334138-2022-00143
• Device Sequence Number: 3927388
• Product Code: LWQ
• UDI-Device Identifier: 05414734053884
• UDI-Public: 05414734053884
• 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: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/07/2022
• Device Model Number: 21AECJ-502
• Device Catalogue Number: 21AECJ-502
• Device Lot Number: 6128571
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2022
• Initial Report FDA Received Date: 02/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/08/2017
• 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 Age: 52 YR
• Patient Sex: Female
• Patient Weight: 69 KG