BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT MX2

    MDR report key: 1081456 · Received July 25, 2008

    Report

    Report Number
    2953200-2008-00597
    Event Type
    Injury
    Date Received
    July 25, 2008
    Date of Event
    January 1, 2008
    Report Date
    June 27, 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
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: INHERENT RISK OF PROCEDURE (EMBOLISM-DEVICE). PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (SEVERELY TORTUOUS WITH SEVERE CALCIFICATION). CONCLUSIONS: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (SEVERELY TORTUOUS WITH SEVERE CALCIFICATION). OTHER, SECONDARY INTERVENTION.

    Description of Event or Problem · 1

    A 2.5 MM DIAMETER X 14 MM LENGTH ENDEAVOR MX2 DRUG-ELUTING CORONARY STENT DELIVERY SYSTEM WAS INSERTED INTO A PATIENT FOR THE TREATMENT OF AN RCA LESION. LESION MORPHOLOGY WAS REPORTED TO BE SEVERELY TORTUOUS WITH SEVERE CALCIFICATION. THE LESION WAS PRE-DILATED. IT WAS REPORTED THAT WHILE ADVANCING TO THE LESION SITE, THE STENT DISLODGED. IT WAS REPORTED THAT THE STENT HAD GOT CAUGHT ON CALCIUM. IT WAS REPORTED THE STENT WAS DEPLOYED. A BARE METAL STENT WAS USED TO TREAT THE LESION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention