BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT OTW

    MDR report key: 1062311 · Received June 18, 2008

    Report

    Report Number
    2953200-2008-00427
    Event Type
    Malfunction
    Date Received
    June 18, 2008
    Date of Event
    May 18, 2008
    Report Date
    May 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL CODES, RESULTS: CONCLUSIONS: (NO FILMS OR PRODUCT REMAINED).

    Description of Event or Problem · 1

    A 3.5 MM DIAMETER X 18 MM LENGTH ENDEAVOR OTW DRUG-ELUTING CORONARY STENT DELIVERY SYSTEM WAS INSERTED INTO A PT FOR THE TREATMENT OF AN UNK LESION. THE VESSEL MORPHOLOGY WAS NOT REPORTED. IT IS UNK IF THE LESION WAS PRE-DILATED. THE PT WAS BROUGHT IN EMERGENTLY WITH AN ACUTE MI. IT WAS REPORTED THAT THE PHYSICIAN WAS BACK LOADING THE DEVICE AND COULD NOT SEE THE STENT ON THE CATHETER. THE STAFF COMMENTED THAT THEY COULD SEE THE STENT AND THE PHYSICIAN PROCEEDED. THE CATHETER WAS AT THE LESION SITE AND THE BALLOON WAS INFLATED. UPON BALLOON INFLATION, THERE WAS NO VISIBLE ANGIOGRAPHIC REFERENCE THAT THE STENT HAD BEEN DEPLOYED. FOLLOWING THE USE OF IVUS, THE PHYSICIAN VERIFIED THAT THE STENT WAS NOT DEPLOYED AT THE LESION SITE. THE STAFF ATTEMPTED TO LOCATE THE STENT, THIS WAS UNSUCCESSFUL. THE LESION WAS TREATED WITH ANOTHER MFR'S STENT. THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT OTW NIQ MEDTRONIC CARDIOVASCULAR GALWAY NA 0000615062

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK