BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALVE CONDUIT CONTEGRA

    MDR report key: 2982739 · Received February 28, 2013

    Report

    Report Number
    2025587-2013-00037
    Event Type
    Injury
    Date Received
    February 28, 2013
    Date of Event
    February 1, 2013
    Report Date
    March 21, 2013
    Manufacturer
    HEART VALVES SANTA ANA
    Product Code
    MWH
    PMA / PMN Number
    H020003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: A REQUEST HAS BEEN MADE FOR THE RETURN OF THE VALVE. AT THIS TIME THE VALVE HAS NOT BEEN RETURNED TO MEDTRONIC; THEREFORE, ANALYSIS HAS NOT BEEN PERFORMED. CONCLUSION: THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS PRODUCT MET ALL MANUFACTURING SPECIFICATION FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION. SHOULD THE PRODUCT BE RETURNED, A FOLLOW UP REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: UPON RECEIPT AT MEDTRONIC'S QUALITY LABORATORY, THE VALVE WAS RECEIVED IN A YELLOWISH SOLUTION IN PRODUCT PACKAGING FOR A SUPPORTED CONTEGRA. THE VALVE WAS 5.9 CM IN LENGTH, ON THE LONG SIDE, AND WAS TRIMMED. THE CONDUIT WAS DISCOLORED SHOWING EVIDENCE OF BLOOD CONTACT. ALL LEAFLETS WERE CLOSED WITH A SMALL GAP AT THE POINT OF COAPTATION, WHEN DRY. ALL LEAFLETS WERE IN THE CLOSED POSITION WITH A SMALL GAP AT THE POINT OF COAPTATION WHEN THE VALVE WAS SUBMERGED ON THE INFLOW. ALL LEAFLETS WERE IN THE CLOSED POSITION WITH A SMALL GAP AT THE POINT OF COAPTATION WHEN THE VALVE WAS SUBMERGED ON THE OUTFLOW. ALL LEAFLETS WERE FLEXIBLE AND INTACT. ONE LEAFLET APPEARED SMALLER THAN THE OTHER TWO LEAFLETS. THE SMALLER LEAFLET APPEARED TO SET LOWER THAN THE OTHER TWO LEAFLETS ON THE INFLOW. THE FREE MARGINS OF ALL LEAFLETS APPEAR UNEVEN ON THE OUTFLOW POSSIBLE DUE TO THE ORIENTATION OF THE SMALLER LEAFLET. ALL COMMISSURES WERE INTACT. CONCLUSION: THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND TO BE ACCEPTABLE. THE VALVED CONDUIT WAS RETURNED FOR ANALYSIS. THE LEAFLETS WERE FLEXIBLE AND INTACT. ONE LEAFLET APPEARED SMALLER AND SET LOWER ON THE INFLOW THAN THE OTHER TWO. IT WAS NOTED THAT WHEN ALL LEAFLETS WERE IN THE CLOSED POSITION, THERE WAS A SMALL GAP AT THE POINT OF COAPTATION. THE FREE MARGINS OF ALL LEAFLETS APPEARED UNEVEN ON THE OUTFLOW POSSIBLY DUE TO THE ORIENTATION OF THE SMALLER LEAFLET. AS THIS CONDUIT IS A NATURAL BOVINE JUGULAR VEIN WITH VALVE, THE LEAFLETS MAY NOT BE THE SAME SIZE. THIS IS ACCEPTABLE PER FINAL INSPECTION SPECIFICATION. ALSO, AS PART OF THE FINAL RELEASE, THE VALVED CONDUIT IS LEAK TESTED. THE ROOT CAUSE OF THE REGURGITATION COULD NOT BE DETERMINED AS THE VALVE MET THE VISUAL INSPECTION CRITERIA AND WAS LEAK TESTED DURING MANUFACTURING. (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT FOLLOWING THE IMPLANT OF THIS PULMONARY VALVED CONDUIT, INTRAOPERATIVE ECHOCARDIOGRAPHY REVEALED CENTRAL REGURGITATION. THE PATIENT WAS PUT BACK ON PUMP AND THE PHYSICIAN ATTEMPTED TO REPOSITION THE VALVE BUT AGAIN, ECHOCARDIOGRAPHY REVEALED REGURGITATION. THE PHYSICIAN ELECTED TO EXPLANT THE VALVE AND IMPLANT A BIOPROSTHETIC VALVE. IT WAS REPORTED THAT THE PATIENT WAS DOING WELL WITH NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE VALVE WAS RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT FOLLOWING THE IMPLANT OF THIS PULMONARY VALVED CONDUIT, INTRAOPERATIVE ECHOCARDIOGRAPHY REVEALED CENTRAL REGURGITATION. THE PATIENT WAS PUT BACK ON PUMP AND THE PHYSICIAN ATTEMPTED TO REPOSITION THE VALVE BUT AGAIN, ECHOCARDIOGRAPHY REVEALED REGURGITATION. THE PHYSICIAN ELECTED TO EXPLANT THE VALVE AND IMPLANT A BIOPROSTHETIC VALVE. IT WAS REPORTED THAT FOLLOWING SURGERY, THE PATIENT WAS DOING WELL WITH NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86819 VALVE CONDUIT CONTEGRA CONDUIT,VALVED,PULMONIC MWH HEART VALVES SANTA ANA PVC222

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R