BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT MX2

    MDR report key: 1063483 · Received June 20, 2008

    Report

    Report Number
    2953200-2008-00454
    Event Type
    Injury
    Date Received
    June 20, 2008
    Date of Event
    May 9, 2008
    Report Date
    May 21, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: RESULTS: EMBOLISM-DEVICE. SECONDARY INTERVENTION.

    Description of Event or Problem · 1

    A 2.5 MM DIAMETER X 18 MM LENGTH ENDEAVOR MX2 DRUG-ELUTING CORONARY STENT DELIVERY SYSTEM WAS INSERTED INTO A PATIENT FOR THE TREATMENT OF AN UNKNOWN LESION. THE VESSEL MORPHOLOGY IS UNKNOWN. IT IS UNKNOWN IF THE LESION WAS PRE-DILATED. IT WAS REPORTED THAT THE PHYSICIAN WAS ATTEMPTING TO DEPLOY THE STENT WHEN THE STENT DISLODGED. THE UNDEPLOYED STENT WAS RETRIEVED WITH A SNARE. NO FURTHER DETAILS HAVE BEEN OBTAINED. THE PATIENT IS FINE. EVALUATION SUMMARY: MEDTRONIC HAS RECEIVED THE DEVICE AND ITS ANALYSIS HAS BEEN COMPLETED. THERE WERE SLIGHT BENDS AND TWISTS AT POINTS ALONG THE SHAFT OF THE DEVICE. THE ENTIRE MID SECTION OF THE STENT WAS SEVERELY DEFORMED AND STRETCHED. THERE WERE A NUMBER OF UN-STRETCHED STENT SEGMENTS AT EACH END OF THE STENT, THE STENT SEGMENTS WERE SQUASHED AND DAMAGED. THE REMAINING STENT SEGMENTS WERE SEVERELY STRETCHED AND DAMAGED. THERE WAS CRIMP/BAKE IMPRESSIONS EVIDENT ON THE BALLOON INDICATING THAT THE STENT WAS CORRECTLY CRIMPED ONTO THE UNINFLATED BALLOON. THE DISTAL TIP WAS SEVERELY DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT MX2 NIQ MEDTRONIC CARDIOVASCULAR GALWAY NA 0000596604

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention