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

Model Number	25AECJ-502
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/21/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2019, a 25mm masters valve was implanted.After the physician cut the retaining sutures and tried to rotate the valve with the holder, it was found that one of the leaflet had fractured into multiple pieces.All of the broken leaflets are recovered.The valve was removed and a 21mm masters valve (b)(4) was implanted instead.There was a clinically significant delay in the procedure.The patient was reported to be stable.
Additional Manufacturer Narrative
The reported event of a dislodged and fractured leaflet was confirmed.One leaflet was dislodged from the orifice and fractured into multiple pieces.No other damage was noted.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.There was no evidence of material defect in the carbon coating that may have caused or contributed to the fractured leaflet.The cause of the reported event could not be conclusively determined, however it is consistent with damage caused by some external force applied to the leaflet and orifice, which overstressed the carbon material.

• Brand Name: SJM MASTERS SERIES VALVE EXPANDED CUFF
• 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: 9074084
• Report Number: 2648612-2019-00066
• Device Sequence Number: 2529728
• Product Code: LWQ
• UDI-Device Identifier: 05414734053907
• UDI-Public: 05414734053907
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 10/30/2019

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: 10/23/2023
• Device Model Number: 25AECJ-502
• Device Catalogue Number: 25AECJ-502
• Device Lot Number: 6707232
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/21/2019
• Supplement Date Received by Manufacturer: 08/21/2019
• Initial Report FDA Received Date: 09/16/2019
• Supplement Report FDA Received Date: 10/30/2019
• 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: 43 YR
• Patient Weight: 48