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

Model Number	29MECJ-502
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/23/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2018, a 29mm masters series valve was chosen for implant in the mitral position.When the physician was suturing the valve in place, a leaflet broke in two pieces.Another 29mm masters series valve was implanted.Although the procedure was extended by 30-45 minutes, no patient consequences were reported.
Additional Manufacturer Narrative
The reported event of a fractured leaflet was confirmed.Two of the three pieces were returned to abbott.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the leaflet fracture remains unknown.However, the damage was consistent with some external force applied to the valve which overstressed the carbon material.Please note, per the instructions for use artmt100122073 ver.A, "do not use instruments other than the valve holder handle to align and seat the valve, and exercise extreme care to avoid putting stress on the valve orifice or leaflets." "before placing sutures in the valve sewing cuff, verify that the valve is mounted correctly on the valve holder/rotator," and "place sutures in the outer half of the valve sewing cuff".

• Brand Name: SJM MASTERS SERIES VALVE EXPANDED CUFF
• 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: 7623057
• Report Number: 2648612-2018-00045
• Device Sequence Number: 1623222
• Product Code: LWQ
• UDI-Device Identifier: 05414734006545
• UDI-Public: 05414734006545
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2018

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: 01/19/2023
• Device Model Number: 29MECJ-502
• Device Catalogue Number: 29MECJ-502
• Device Lot Number: 6287501
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/25/2018
• Supplement Date Received by Manufacturer: 08/09/2018
• Initial Report FDA Received Date: 06/20/2018
• Supplement Report FDA Received Date: 08/27/2018
• 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: Other