BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT OTW

    MDR report key: 1030451 · Received April 17, 2008

    Report

    Report Number
    2953200-2008-00226
    Event Type
    Malfunction
    Date Received
    April 17, 2008
    Date of Event
    January 1, 2008
    Report Date
    March 19, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE DELIVERY CATHETER WAS RETURNED TO MEDTRONIC AND THE ANALYSIS HAS BEEN COMPLETED. THE REPORTED DEFLATION DIFFICULTIES ARE UNCONFIRMED AS THE DEFLATION TIME TESTING ON THE RETURNED DEVICES MET SPECIFICATIONS. IT APPEARS MOST LIKELY THAT THE DEFLATION TIME ISSUES REPORTED WERE MOST LIKELY PROCEDURAL RELATED BUT THE ROOT CAUSE OF THE REPORTED DEFLATION ISSUES IS UNDETERMINED.

    Description of Event or Problem · 1

    AN ENDEAVOR OTW DRUG-ELUTING CORONARY STENT DELIVERY SYSTEM WAS IMPLANTED INTO A PATIENT FOR THE TREATMENT OF AN SVG LESION. IT WAS REPORTED THAT THE ENDEAVOR DRUG-ELUTING STENT WAS PLACED AND THE BALLOON INFLATION WAS COMPLETED. IT WAS REPORTED THAT THE DELIVERY BALLOON DID NOT APPEAR TO BE DEFLATING UNTIL 10 SECONDS AFTER NEGATIVE PRESSURE WAS APPLIED. THE TOTAL TIME THAT IT TOOK FOR THE BALLOON TO DEFLATE WAS APPROXIMATELY 20-25 SECONDS. THERE WERE TWO DEVICES (MDR# 2953200-2008-00226 AND 2953200-2008-00227) WITH THE SAME EVENT THAT OCCURRED IN THE SAME PATIENT. THE PATIENT WAS REPORTED TO BE FINE AND NO ADDITIONAL CLINICAL SEQUELAE HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT OTW NIQ MEDTRONIC CARDIOVASCULAR GALWAY NA 0000584269

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK