BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT MX2

    MDR report key: 1063479 · Received June 20, 2008

    Report

    Report Number
    2953200-2008-00449
    Event Type
    Injury
    Date Received
    June 20, 2008
    Date of Event
    May 23, 2008
    Report Date
    May 23, 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
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL CONCLUSION: OTHER - LACK OF INFO (DEVICE NOT RETURNED, NO FILMS OR OPERATIVE REPORTS WERE PROVIDED). (REQUIRED SECONDARY INTERVENTION).

    Description of Event or Problem · 1

    A 2.5 MM DIAMETER X 24 MM LENGTH ENDEAVOR MX2 DRUG-ELUTING CORONARY STENT DELIVERY SYSTEM WAS INSERTED INTO A PT FOR THE TREATMENT OF AN RCA LESION. THE VESSEL MORPHOLOGY IS UNK. IT IS UNK IF THE LESION WAS PRE-DILATED. IT IS REPORTED THAT THE PHYSICIAN WAS ATTEMPTING TO WITHDRAW THE STENT FROM THE RCA WHEN IT DISLODGED. THE PHYSICIAN WAS ABLE TO INSERT A BALLOON INSIDE THE STENT AND SUCCESSFULLY DEPLOY THE STENT AT AN UNK SITE. THE PT WAS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT MX2 NIQ MEDTRONIC CARDIOVASCULAR GALWAY NA 0000585502

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention