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

Model Number	27MECJ-502
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Type of Reportable Event	Death
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
Event or Problem Description
This event is being conservatively reported for the patient's death as the date and cause of the patient's death was unknown.It was reported that on (b)(6) 2021, a 27 mm sjm masters series valve expanded cuff was implanted for a mitral valve replacement.During a follow-up visit in (b)(6) 2021, the patient was identified with having a prosthetic valve thrombosis episode.The patient was re-admitted for thrombolytic therapy.It was also reported that the patient died on an unknown date.No additional information was provided.
Event or Problem Description
Further information regarding this event was requested, but no additional information was available from the hospital administration regarding this event.
Additional Manufacturer Narrative
An event of thrombosis and death were reported.A more comprehensive assessment could not be performed as the device remains implanted 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.

• 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: 13085472
• Report Number: 3007113487-2021-00130
• Device Sequence Number: 14814471
• Product Code: LWQ
• UDI-Device Identifier: 05414734006453
• UDI-Public: 05414734006453
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/07/2025
• Device Model Number: 27MECJ-502
• Device Catalogue Number: 27MECJ-502
• Device Lot Number: 7545235
• Was Device Available for Evaluation?: No
• 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: 11/26/2021
• Supplement Date Received by Manufacturer: 12/22/2021
• Initial Report FDA Received Date: 12/24/2021
• Supplement Report FDA Received Date: 01/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2020
• 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: Death
• Patient Sex: Unknown