BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTEGRA PULMONARY VALVED CONDUIT - SUPPORTED

    MDR report key: 4760438 · Received May 8, 2015

    Report

    Report Number
    2025587-2015-00534
    Event Type
    Injury
    Date Received
    May 8, 2015
    Date of Event
    August 9, 2003
    Report Date
    May 28, 2015
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    MWH
    PMA / PMN Number
    H020003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES WERE NOT RETURNED TO MEDTRONIC. (B)(4). TITLE: SURPRISING OUTCOME SIMILARITIES BETWEEN CONTEGRA BOVINE JUGULAR VEIN CONDUIT AND SHELHIGH NO-REACT PORCINE PULMONARY VALVE CONDUIT: ROLE OF IMMUNOLOGIC REACTION AUTHORS: YOUNES BOUDJEMLINE, CONSTANCE BEYLER, DAMIEN BONNET, DANIEL SIDI CITATION: EUROPEAN JOURNAL OF CARDIO-THORACIC SURGERY 24 (2003) 850¿851.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO DEVICE WAS RETURNED, AND NO UNIQUE DEVICE IDENTIFIER NUMBERS WERE PROVIDED. WITHOUT THIS INFORMATION A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED AND ROOT CAUSE COULD NOT BE IDENTIFIED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT THE AUTHORS OF A LETTER TO EDITOR OBSERVED EXTENSIVE INTIMAL PROLIFERATION AT THE DISTAL ANASTOMOSIS AND THROMBI FORMATION IN PULMONARY VALVED CONDUIT (MODEL/SERIAL NOT PROVIDED). ALSO NOTED, SEVERE DISTAL OBSTRUCTION THAT LED TO PROXIMAL ANEURYSMAL DILATION OF THE CONDUIT, CAUSING VALVE LEAK AND INCREASED VOLUME LOAD, AND SUBSEQUENTLY RESULTING IN RIGHT VENTRICULAR DYSFUNCTION. IN THE AUTHORS OPINION, ADDITIONAL FACTORS OF CAUSE MIGHT INCLUDE ENDOTHELIAL LESIONS MADE DURING CONDUIT SUTURE, RESIDUAL GLUTARALDEHYDE RELEASE FROM THE IMPLANT, AND SHEAR STRESS RELATED TO HEMODYNAMIC LOCAL CONDITION. NO SUPPORTING DATA WAS PROVIDED REGARDING PATIENT DEMOGRAPHICS, NUMBER OF DEVICES IMPLANTED, OR NUMBER OF OBSERVATIONS HAVING OCCURRED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305027 CONTEGRA PULMONARY VALVED CONDUIT - SUPPORTED CONDUIT,VALVED,PULMONIC MWH MEDTRONIC HEART VALVES DIVISION UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening