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

Model Number 27MJ-501

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cardiac Perforation (2513)

Event Date 03/13/2019

Event Type  Injury  

Event Description

On (b)(6) 2019, a 27mm masters mechanical valve was selected for implant.After the aortic cross-clamp was removed, the left ventricular wall was confirmed to be bleeding.The tear was located near the native annulus, about 5-10mm below the native annulus.The tear was surgically closed.A small perforation was also observed.The user reported that the bleeding could be due to implant of too large size of the valve, or maybe caused by unconscious damage during the procedure.The 27mm was explanted and a 25mm masters was implanted.The patient is reported to be recovering.

Manufacturer Narrative

An event of a tear was reported.The investigation confirmed the device met visual specifications when analyzed at abbott, with no damage or anomalies seen to the valve.The valve rotated and the leaflets opened and closed without resistance.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications at the time of commercialization.The cause of the tear could not be conclusively determined; however, a smaller, 25mm, valve was implanted and per the site "the bleeding could be due to implant of too large size of the valve, or maybe caused by unconscious damage during the procedure".

• Brand Name: SJM MASTERS SERIES MECHANICAL HEART VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725
• MDR Report Key: 8526805
• MDR Text Key: 142334130
• Report Number: 2648612-2019-00026
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734006460
• UDI-Public: 05414734006460
• 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: 06/20/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2023
• Device Model Number: 27MJ-501
• Device Catalogue Number: 27MJ-501
• Device Lot Number: 6591292
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/26/2019
• Initial Date FDA Received: 04/18/2019
• Supplement Dates Manufacturer Received: 05/23/2019
• Supplement Dates FDA Received: 06/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR