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

Model Number	27MJ-501
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/21/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2019, a 27mm masters valve was selected for implant.While testing the valve after implantation, a metallic piece was observed to be detached.The valve was explanted and replaced with another 27mm masters valve (serial number: unknown).The procedure was extended 30 minutes.Additional information is requested.
Additional Manufacturer Narrative
The reported event of a dislodged leaflet was confirmed.One leaflet had dislodged from the orifice and was returned reinserted.There was chipping on two butterfly pivot areas.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 leaflet dislodgement and damage could not be conclusively determined; however, it was consistent with some external force applied to the leaflet and orifice, which overstressed the carbon material and resulted in the damage.
Event or Problem Description
On (b)(6) 2019, a 27mm masters valve was selected for implant.After implantation, the valve was tested with a leaflet tester and a leaflet was observed to be detached.The valve was explanted and replaced with another 27mm masters valve (serial number: unknown) and no patient consequences were reported.Per site, the procedure and cardiac pump time were extended 30 minutes.
Event or Problem Description
On (b)(6) 2019, a 27mm masters valve was selected for implant.After implantation, the valve was tested with the valve holder and a leaflet was observed to be detached.The valve was explanted and replaced with another 27mm masters valve (serial number: unknown) and no patient consequences were reported.Per site, the procedure and cardiac pump time were extended 30 minutes.

• Brand Name: SJM MASTERS SERIES MECHANICAL HEART VALVE
• Common Device Name: 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: 8374425
• Report Number: 2648612-2019-00014
• Device Sequence Number: 16695205
• Product Code: LWQ
• UDI-Device Identifier: 05414734006460
• UDI-Public: 05414734006460
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/25/2019

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: 10/19/2023
• Device Model Number: 27MJ-501
• Device Catalogue Number: 27MJ-501
• Device Lot Number: 6701890
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/25/2019
• Supplement Date Received by Manufacturer: 02/28/2019; 05/29/2019
• Initial Report FDA Received Date: 02/27/2019
• Supplement Report FDA Received Date: 03/25/2019; 06/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention