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

Model Number 31MECJ-502

Device Problem Insufficient Information (3190)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/14/2020

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

On (b)(6) 2020, the physician selected a 31mm masters valve to implant.For an unknown reason, the 31mm masters valve was implanted then explanted and exchanged for a 27mm mechanical valve (sn (b)(4)).The 27mm valve dropped due to poor coordination.Another 27mm valve (sn (b)(4)) was used to complete the procedure.No patient consequences was reported.Additional information was requested.

Manufacturer Narrative

Additional information for: g4, g7, h2, h6, and h10 an event of implanting and then explanting a 31mm masters valve for an unknown reason was reported.A smaller 27mm valve was successfully implanted.The results of the investigation are inconclusive since 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.

• Brand Name: SJM MASTERS SERIES VALVE EXPANDED CUFF
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725
• MDR Report Key: 9800714
• MDR Text Key: 189432645
• Report Number: 2648612-2020-00023
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734006613
• UDI-Public: 05414734006613
• Combination Product (y/n): N
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 04/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 31MECJ-502
• Device Catalogue Number: 31MECJ-502
• Device Lot Number: 7204342
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/06/2020
• Initial Date FDA Received: 03/06/2020
• Supplement Dates Manufacturer Received: 03/18/2020
• Supplement Dates FDA Received: 04/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention