BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTEGRA PULMONARY VALVED CONDUIT - SUPPORTED

    MDR report key: 3895630 · Received June 25, 2014

    Report

    Report Number
    2025587-2014-00421
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    June 2, 2014
    Report Date
    July 10, 2014
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    MWH
    PMA / PMN Number
    H020003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION OBTAINED BY MEDTRONIC WAS FROM A JOURNAL ARTICLE ABSTRACT THAT DID NOT INCLUDE INFORMATION ON HOW TO CONTACT THE AUT HOR(S) FOR ADDITIONAL INFORMATION OR TO REQUEST DEVICE SERIAL NUMBERS. THE FAILURE MECHANISM WAS NOT SEGMENTED OUT SPECIFIC TO THE CONDUITS. A DEVICE HISTORY RECORDS REVIEW COULD NOT BE CONDUCTED WITHOUT DEVICE SERIAL NUMBERS.

    Additional Manufacturer Narrative · 1

    ALL THE CONDUITS REMAIN IMPLANTED AND WILL NOT BE RETURNED. 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. CITATION: PERCUTANEOUS IMPLANTATION OF THE EDWARDS SAPIEN(¿) PULMONIC VALVE: INITIAL RESULTS IN THE FIRST 22 PATIENTS. HAAS NA , MOYSICH A, NEUDORF U, MORTEZAEIAN H, ABDEL-WAHAB M, SCHNEIDER H, DE WOLF D, PETIT J, NARAYANSWAMI S, LASER KT, SANDICA E. CLIN RES CARDIOL. 2013 FEB;102(2):119-28. DOI: 10.1007/S00392-012-0503-8. EPUB 2012 AUG 30. (B)(4).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION FROM AN ABSTRACT IN CLIN RES CARDIOL 2013 FEB, THAT STUDIED 22 IMPLANTS OF A NON-MEDTRONIC TRANSCATHETER BIOPROSTHETIC VALVE. THE ABSTRACT STATED THE TRANSCATHETER BIOPROSTHETIC VALVE WAS IMPLANTED INTO 11 FAILED MEDTRONIC VALVED CONDUITS IN THE PULMONARY POSITION (ALONG WITH OTHER NON-MEDTRONIC HOMOGRAFTS AND CONGENITAL REPAIR PRODUCTS). THE MEAN AGE WAS 21.7 YEARS (RANGE 6-83 YEARS). THE FAILURE MECHANISM WAS NOT SEGMENTED OUT SPECIFIC TO THE CONDUITS, HOWEVER, THE LEADING HEMODYNAMIC PROBLEM FOR THE 22 IMPLANTS CONSISTED OF A PULMONARY STENOSIS (PS) (N = 2), PULMONARY REGURGITATION (PR) (N = 11) AND A COMBINED PS/PR LESION (N = 9). THE ARTICLE CONCLUDED THAT THIS IMPLANT ENABLES THE RESTORATION OF AN ADULT-SIZE RVOT DIAMETER. LONG TERM EFFECTS AND SAFETY HAVE NOT BEEN ASSESSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371407 CONTEGRA PULMONARY VALVED CONDUIT - SUPPORTED CONDUIT,VALVED,PULMONIC MWH MEDTRONIC HEART VALVES DIVISION 200S

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention