BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT MX2

    MDR report key: 1162826 · Received September 16, 2008

    Report

    Report Number
    2953200-2008-00815
    Event Type
    Injury
    Date Received
    September 16, 2008
    Date of Event
    January 1, 2008
    Report Date
    August 18, 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
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: EMBOLISM-DEVICE, OCCLUSION. SEVERELY TORTUOUS. SECONDARY INTERVENTION.

    Description of Event or Problem · 1

    A 3.0 MM DIAMETER X 12 MM LENGTH ENDEAVOR MX2 DRUG-ELUTING CORONARY STENT DELIVERY SYSTEM WAS INSERTED INTO A PATIENT FOR THE TREATMENT OF A MID-PROXIMAL RCA LESION. LESION MORPHOLOGY WAS REPORTED TO BE SEVERELY TORTUOUS. THE LESION WAS PRE-DILATED. IT WAS REPORTED THAT THE DELIVERY SYSTEM WAS INSERTED; HOWEVER, THE STENT WAS UNABLE TO CROSS THE LESION. THE DELIVERY SYSTEM WAS PULLED BACK INTO THE GUIDE AND THEN ATTEMPTED A SECOND TIME. THE STENT WAS UNABLE TO CROSS THE LESION; THE DELIVERY SYSTEM WAS BROUGHT BACK INTO THE GUIDE AND THE STENT STRIPPED OFF OF THE DELIVERY SYSTEM. THE UN-DEPLOYED STENT WAS DEPLOYED IN THE PROXIMAL RCA WITH ANOTHER MANUFACTURER'S BALLOON. THE VESSEL CLOSED DOWN AND THERE WERE UNSURE OF THE REASON. THEY WERE GETTING A LOT OF LOT OF CLOT ONTO THE BALLOON SYSTEMS WHEN DILATING THE LESION SITE. THERE WAS A SEVERE AMOUNT OF CLOT IN THE PROXIMAL VESSEL, IT WAS COMPLETELY CLOSED. A BALLOON PUMP WAS SEWN IN. THE PATIENT IS STABLE 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 0000697177

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention