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

Model Number 31MJ-501

Device Problem Perivalvular Leak (1457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/18/2020

Event Type  Injury  

Manufacturer Narrative

Further information regarding this event has been requested.The investigation results will be provided in a subsequent submission.

Event Description

On (b)(6) 2020 a 31mm sjm masters series mechanical heart valve was implanted in the patient's mitral position a sjm sizer was used in the surgery.A pvl occurred on the patient leading to re-do mvr was performed on (b)(6) 2020, and the masters valve was explanted, replaced with a mosaic bioprosthesis(manufacturer: medtronic).There was no clinically significant delay in the mvr, and the patient remained hemodynamically stable during the surgery.The patient is in stable condition postoperatively.

Manufacturer Narrative

An event of paravalvular leak was reported.A more comprehensive assessment could not be performed as 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 MECHANICAL HEART VALVE
• 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: 11154006
• MDR Text Key: 226240945
• Report Number: 2648612-2021-00002
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734006620
• UDI-Public: 05414734006620
• 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
• Type of Report: Initial,Followup
• Report Date: 01/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 31MJ-501
• Device Catalogue Number: 31MJ-501
• Device Lot Number: 7013130
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 66 YR