BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRASTENT MAX LD

    MDR report key: 8277745 · Received January 25, 2019

    Report

    Report Number
    2183870-2019-00034
    Event Type
    Malfunction
    Date Received
    January 25, 2019
    Date of Event
    June 1, 2018
    Report Date
    January 25, 2019
    Manufacturer
    COVIDIEN
    Product Code
    FGE
    PMA / PMN Number
    K020528
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE, WEIGHT ¿ MEAN STUDY AGE AND WEIGHT, GENDER: STUDY MAJORITY EVENT DATE: DATE OF PUBLICATION UP TO 11 YEARS OF EXPERIENCE WITH THE MELODY VALVED STENT IN THE RIGHT VENTRICULAR OUTFLOW TRACT 2018;14:E988-E994 BJORN COOLS, STEVEN BROWN, WERNER BUDTS DOI 10.4244/EIJ-D-18-00054. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE AIM OF THE STUDY WAS TO REPORT UP TO 11 YEARS OF FOLLOW-UP AFTER MELODY VALVE IMPLANTATION IN THE PULMONARY POSITION. ONE HUNDRED AND EIGHTY-EIGHT (N=188) MELODY VALVES WERE IMPLANTED IN 186 PATIENTS OVER THIS 11-YEAR PERIOD. THIS STUDY REPORTS ON FOLLOW-UP OF 188 VALVES IN 185 PATIENTS DISCHARGED WITH A MELODY VALVE. THE PROTOCOL CONSISTED OF FOLLOW-UP AT 1, 3, 6 AND 12 MONTHS, FOLLOWED BY ANNUAL VISITS THEREAFTER. THIS INCLUDED RADIOGRAPHY TO ASSESS FOR THE PRESENCE OF STENT FRACTURES AS WELL AS ROUTINE TRANSTHORACIC ECHOCARDIOGRAPHIC EXAMINATION. THE MAX LD STENT WAS USED DURING RVOT (RIGHT VENTRICULAR OUTFLOW TRACT) PRE-STENTING WHICH WERE IMPLANTED TO ENSURE A STABLE LANDING ZONE WITH NO RECOIL OR DISTORTION; CARE WAS TAKEN TO ABOLISH ALL GRADIENTS PRIOR TO MELODY VALVE IMPLANTATION. A TOTAL OF 226 PRE-STENTS WERE IMPLANTED INCLUDING 2 MAX LD STENTS. STENT FRACTURES (TYPE 1) WERE OBSERVED IN 14 PATIENTS WITH A MEAN VALUE OF 4.2 YEARS AFTER IMPLANT. NONE OF THE MINOR FRACTURES RESULTED IN HAEMODYNAMIC CONSEQUENCES. FREEDOM FROM STENT FRACTURES WAS 82% AT 11 YEARS. ENDOCARDITIS WAS DIAGNOSED IN 19 10.2% PATIENTS AT A MEDIAN TIME OF 2.3 YEARS AFTER MELODY IMPLANTATION. THE MEDIAN AGE AT THE TIME OF ENDOCARDITIS WAS 16.2 YEARS WITH A STRONG MALE PREPONDERANCE. POSITIVE BACTERIAL IDENTIFICATION WAS OBTAINED IN 89.4% OF THE CASES: STAPHYLOCOCCI SPECIES (N=6), STREPTOCOCCUS VIRIDANS (N=5), HACEK GROUP (N=2) AND OTHER (N=4). IN TWO PATIENTS NO ORGANISMS WERE CULTURED. THIRTEEN PATIENTS HAD FAILURE OF THE GRAFT REQUIRING REPLACEMENT: IN SEVEN PATIENTS THE STENT WAS SURGICALLY REMOVED DUE TO ENDOCARDITIS (6 PATIENTS) AND SUB-PULMONARY STENOSIS (1 PATIENT). IN FIVE PATIENTS A REDO PPVI WAS PERFORMED FOR STENOSIS AFTER ENDOCARDITIS (3 PATIENTS), CONDUIT STENOSIS 10.3 YEARS AFTER INITIAL IMPLANT (1 PATIENT) AND TYPE III STENT FRACTURE 5.2 YEARS POST IMPLANT (1 NON-MEDTRONIC STENT). THERE WERE THREE LATE DEATHS, NONE OF WHICH WAS RELATED TO THE PROCEDURE OR RELATED TO THE VALVE OVERALL: ONE PATIENT DIED FROM KIDNEY FAILURE AT THE AGE OF (B)(6) YEARS, ONE DUE TO STATUS EPILEPTICUS AT THE AGE OF (B)(6) YEARS AND ONE SUDDEN DEATH DURING SLEEP AT THE AGE OF (B)(6) YEARS (NO AUTOPSY WAS PERFORMED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    70301 INTRASTENT MAX LD CATHETER, BILIARY, DIAGNOSTIC FGE COVIDIEN UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR