BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT MX2

    MDR report key: 1021231 · Received March 28, 2008

    Report

    Report Number
    2953200-2008-00170
    Event Type
    Injury
    Date Received
    March 28, 2008
    Date of Event
    February 29, 2008
    Report Date
    February 29, 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
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS - INHERENT RISK OF PROCEDURE (CORONARY ARTERY DISSECTION). INCORRECT TECHNIQUE/PROCEDURE (INADVERTENT AIR INJECTION). CONCLUSIONS - DEVICE DISCARDED UNABLE TO FOLLOW UP (DELIVERY CATHETER). USER ERROR CONTRIBUTED TO EVENT (INADVERTENT AIR INJECTION).

    Description of Event or Problem · 1

    A 2.5MM DIAMETER X 14MM LENGTH. ENDEAVOR MX2 DRUG-ELUTING CORONARY STENT DELIVERY SYSTEM WAS SUCCESSFULLY IMPLANTED INTO A PT FOR THE TREATMENT OF A DIFFUSE MIDDLE TO PROXIMAL LAD LESION. THE LESION MORPHOLOGY WAS REPORTED TO BE MILD TORTUOSITY, MILD CALCIFICATION AND 85 PERCENT STENOSIS. THE LESION WAS PRE-DILATED. IT WAS REPORTED THAT THE PHYSICIAN WAS PREPARING FOR POST DEPLOYMENT ANGIOGRAM, WHEN THE INJECTION OF 10CC OF AIR WENT DOWN THE LAD CAUSING A SPIRAL DISSECTION. THE PHYSICIAN BELIEVES THAT THE DISSECTION WAS CAUSED BY AIR INJECTION IN WHICH OUR PRODUCTS WERE INVOLVED IN THE CASE, BUT THE PHYSICIAN DOES NOT BELIEVE THE SDS USED WAS THE CAUSE OF THE DISSECTED VESSEL. THE PT WAS SENT TO THE OR FOR CABG. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PT 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 50 YR Required Intervention