BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT MX2

    MDR report key: 1012334 · Received February 12, 2008

    Report

    Report Number
    2953200-2008-00126
    Event Type
    Injury
    Date Received
    February 12, 2008
    Date of Event
    February 8, 2008
    Report Date
    February 11, 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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A 3.0 MM DIAMETER X 24 MM LENGTH ENDEAVOR MX2 DRUG-ELUTING CORONARY STENT DELIVERY SYSTEM WAS INSERTED INTO A PATIENT FOR THE TREATMENT OF AN LAD LESION WITH IN-STENT RESTENOSIS IN THE MID LAD. THE VESSEL MORPHOLOGY WAS REPORTED TO BE SEVERELY TORTUOUS WITH SEVERE CALCIFICATION. THE LESION WAS PRE-DILATED. IT WAS REPORTED THAT ANOTHER MANUFACTURER'S DRUG-ELUTING STENT WAS ATTEMPTED FIRST, HOWEVER, WAS UNABLE TO CROSS THE LESION. IT WAS REPORTED THAT THE PHYSICIAN THEN ATTEMPTED THE ENDEAVOR 30 X 24; THE STENT REACHED THE PROXIMAL LAD ARTERY AND WHILE ATTEMPTING TO FURTHER ADVANCE THE STENT IT APPEARED THAT THE STENT HAD DISLODGED. THE UNDEPLOYED STENT WAS LOCATED IN THE LEFT MAIN. THE PHYSICIAN USED ANOTHER MANUFACTURER'S BALLOON TO SUCCESSFULLY DEPLOY THE STENT IN THE PROXIMAL LAD. IT WAS REPORTED THAT THE PHYSICIAN MADE MULTIPLE UNSUCCESSFUL ATTEMPTS TO STENT THE LESION SITE. THE PHYSICIAN THEN PERFORMED ADDITIONAL BALLOON INFLATIONS IN ORDER TO DELIVER A STENT, BUT THE STENT CONTINUALLY BECAME HUNG UP IN THE SAME AREA WITHIN THE LEFT MAIN AND PROXIMAL LAD. THE CASE WAS COMPLETED AND THE PATIENT IS FINE AND WILL BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT MX2 NIQ MEDTRONIC CARDIOVASCULAR GALWAY NA 0000594660

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention