BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTEGRA

    MDR report key: 5247949 · Received November 24, 2015

    Report

    Report Number
    2025587-2015-01234
    Event Type
    Injury
    Date Received
    November 24, 2015
    Date of Event
    March 9, 2014
    Report Date
    December 29, 2015
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    MWH
    PMA / PMN Number
    H020003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TITLE: WHICH TYPE OF CONDUIT TO CHOOSE FOR RIGHT VENTRICULAR OUTFLOW TRACT RECONSTRUCTION IN PATIENTS BELOW 1 YEAR OF AGE? CITATION: EUROPEAN JOURNAL OF CARDIO-THORACIC SURGERY 46 (2014) 961¿966 (DOI:10.1093/EJCTS/EZU080) AUTHORS: KETI VITANOVA, JULIE CLEUZIOU,*, JÜRGEN HÖRERA, JELENA KASNAR-SAMPREC, MANFRED VOGT, CHRISTIAN SCHREIBER AND RÜDIGER LANGE. (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 VIA LITERATURE REVIEW THAT A STUDY WAS PERFORMED TO EVALUATE THE DURABILITY OF AND FREEDOM FROM REPLACEMENT BETWEEN HOMOGRAFT, BOVINE JUGULAR VEIN, AND PORCINE-VALVED DACRON CONDUITS USED IN RIGHT VENTRICULAR OUTFLOW TRACT (RVOT) RECONSTRUCTION. THE STUDY POPULATION INCLUDED 145 PATIENTS, ALL YOUNGER THAN ONE YEAR OF AGE, WHOM UNDERWENT RVOT RECONSTRUCTION BETWEEN 1994 AND 2011 AT A SINGLE (B)(6). AMONG ALL PATIENTS, 35 PATIENTS (GENDER NOT PROVIDED, MEAN AGE 4 MONTHS OLD) WERE IMPLANTED WITH A MEDTRONIC BOVINE JUGULAR VEIN VALVED CONDUIT (MEAN SIZE 12-MM, SERIAL NUMBERS NOT PROVIDED), AND 48 PATIENTS (GENDER NOT PROVIDED, MEAN AGE 3.6 MONTHS OLD) WERE IMPLANTED WITH A MEDTRONIC PORCINE-VALVED DACRON CONDUIT (MEAN SIZE 12-MM, SERIAL NUMBERS NOT PROVIDED). ACROSS ALL PATIENTS, 15 EARLY DEATHS OCCURRED (5 DUE TO INTRAOPERATIVE HEART FAILURE, 5 DUE TO PULMONARY HYPERTENSION WITH RIGHT VENTRICLE (RV) FAILURE, 3 DUE TO VENTRICULAR FIBRILLATION, AND 2 DUE TO UNKNOWN CAUSES). OF THESE 15 DEATHS, 4 PATIENTS HAD RECEIVED A MEDTRONIC BOVINE JUGULAR VEIN VALVED CONDUIT AND 4 PATIENTS HAD RECEIVED A MEDTRONIC PORCINE-VALVED DACRON CONDUIT; HOWEVER, NONE OF THE DEATHS WERE ATTRIBUTED TO MEDTRONIC PRODUCT. ACROSS ALL PATIENTS 5 LATE DEATHS OCCURRED (3 DUE TO SEPTIC SHOCK, 1 DUE TO CONVULSIVE SEIZURES, AND 1 DUE TO UNKNOWN CAUSES). OF THESE 5 DEATHS, 3 HAD RECEIVED A MEDTRONIC PORCINE-VALVED DACRON CONDUIT; HOWEVER, NONE OF THE DEATHS WERE ATTRIBUTED TO MEDTRONIC PRODUCT. OF THE PATIENTS IMPLANTED A MEDTRONIC BOVINE JUGULAR VEIN VALVED CONDUIT, OVERALL FREEDOM FROM CONDUIT EXPLANT WAS 59.4% AT 5 YEARS, WHICH INCLUDED 11 EXPLANTS DUE TO VALVULAR STENOSIS, 5 EXPLANTS DUE TO INSUFFICIENCY, AND 1 EXPLANT DUE TO ENDOCARDITIS (AT 5.3 YEARS POST-IMPLANT). OF THE PATIENTS IMPLANTED WITH A MEDTRONIC PORCINE-VALVED DACRON CONDUIT, OVERALL FREEDOM FROM CONDUIT EXPLANT WAS 53.8% AT 5 YEARS, WHICH INCLUDED 19 EXPLANTS DUE TO VALVULAR STENOSIS, 3 EXPLANTS DUE TO INSUFFICIENCY, AND 4 EXPLANTS DUE TO THROMBUS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION FROM THE PHYSICIAN AUTHOR STATED THAT MEDTRONIC PRODUCT DID NOT CONTRIBUTE TO ANY DEATHS. REGARDING ADVERSE EVENTS, MEDTRONIC PRODUCTS PERFORMED SIMILAR TO HOMOGRAFTS IN FREEDOM FROM REPLACEMENT AND DURABILITY. OF 145 TOTAL PATIENTS, 79 WERE MALE AND 66 WERE FEMALE. THE MEAN PATIENT WEIGHT WAS 4.4 KG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    778278 CONTEGRA CONDUIT,VALVED,PULMONIC MWH MEDTRONIC HEART VALVES DIVISION 200H12

    Patients

    Seq Age Sex Outcome Treatment
    1 00004 MO Required Intervention