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

Model Number 27MECJ-502

Device Problem Biocompatibility (2886)

Patient Problem Thrombosis/Thrombus (4440)

Event Type  Death  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event 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 Description

Further information regarding this event was requested, but no additional information was available from the hospital administration regarding this event.

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
• Type of Device: 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
• MDR Text Key: 282766783
• Report Number: 3007113487-2021-00130
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734006453
• UDI-Public: 05414734006453
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 12/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death