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

Model Number	27MJ-501
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	03/13/2019
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 2648612-2019-00026
• Device Sequence Number: 19300526
• Product Code: LWQ
• UDI-Device Identifier: 05414734006460
• UDI-Public: 05414734006460
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 03/26/2019
• Supplement Date Received by Manufacturer: 05/23/2019
• Initial Report FDA Received Date: 04/18/2019
• Supplement Report FDA Received Date: 06/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 51 YR