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

Model Number	31MECJ-502
Medical Device Problem Codes	Obstruction of Flow (2423); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/07/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2018, a 31mm masters series mitral valve ((b)(4)) and 23mm masters series aortic valve ((b)(4)) were implanted during a concomitant mvr and avr procedure.A leaflet tester was used to test function of the leaflets.While weaning the patient from cardiopulmonary bypass, the pa pressure was noted to be very low.The left atrium was reopened and one leaflet from the mitral valve was noted to be dislodged from the butterfly hinge and had obstructing both leaflets.The mitral valve was explanted and a second 31mm masters series mitral valve was implanted.The patient is reported to be stable and has moved to the icu with all the parameters within normal range.
Additional Manufacturer Narrative
The reported event of ¿leaflet from the mitral valve was noted to be dislodged from the butterfly hinge¿ was confirmed.The reported event of ¿obstruction of the leaflets¿ was not confirmed.The returned 31mm masters series valve was returned with one leaflet dislodged and fractured.There was no evidence of material defect in the carbon coating that may have caused or contributed to the dislodged and fractured leaflet.Rather, the dislodged and fractured leaflet is consistent with some external force applied to the valve which overstressed the carbon material.The intact leaflet was properly inserted within the orifice and able to fully open and close with no resistance occurring.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported event remains unknown.

• 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: 7820632
• Report Number: 2648612-2018-00064
• Device Sequence Number: 19444778
• Product Code: LWQ
• UDI-Device Identifier: 05414734006613
• UDI-Public: 05414734006613
• 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: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2018

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: 12/10/2022
• Device Model Number: 31MECJ-502
• Device Catalogue Number: 31MECJ-502
• Device Lot Number: 6242778
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/08/2018
• Supplement Date Received by Manufacturer: 10/25/2018
• Initial Report FDA Received Date: 08/27/2018
• Supplement Report FDA Received Date: 11/07/2018
• 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: Required Intervention
• Patient Age: 26 YR
• Patient Weight: 52