BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT OTW

    MDR report key: 1040638 · Received May 8, 2008

    Report

    Report Number
    2953200-2008-00295
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    April 4, 2008
    Report Date
    April 10, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL CODES, RESULTS: PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (SEVERELY TORTUOUS AND SEVERELY CALCIFIED VESSELS). INHERENT RISK OF PROCEDURE (EMBOLISM-DEVICE). CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PT CONDITION.

    Description of Event or Problem · 1

    A 2.5 MM X 18 MM ENDEAVOR OTW DRUG-ELUTING CORONARY STENT DELIVERY SYSTEM WAS INSERTED INTO A PT FOR THE TREATMENT OF AN RCA LESION. THE VESSEL MORPHOLOGY WAS SEVERE TORTUOSITY AND SEVERE CALCIFICATION. IT WAS REPORTED THAT THE PHYSICIAN INSERTED THE ENDEAVOR DELIVERY SYSTEM AND WAS EXPERIENCING DIFFICULTY WHILE TRYING TO ADVANCE THE SDS OUT OF THE GUIDE CATHETER. THERE ALSO RESISTANCE FELT WHEN THE PHYSICIAN TRIED TO REMOVE THE SDS. THE PHYSICIAN DECIDED TO REMOVE THE GUIDE CATHETER AND SDS, AND UPON EXAMINATION OF THE SDS, THE PHYSICIAN NOTICED THAT THE STENT WAS NOT ON THE BALLOON. THE PHYSICIAN WAS ABLE TO SEE THAT THE STENT WAS IN THE SHEATH, AND WAS ABLE TO REMOVE THE STENT FROM THE SHEATH. NO CLINICAL SEQUELAE WERE REPORTED, AND THE PT IS FINE. MEDTRONIC HAS RECEIVED THE DEVICE AND ITS ANALYSIS HAS BEEN COMPLETED. THE SDS WAS RETURNED SEPARATELY FROM THE SEVERELY STRETCHED STENT. THERE WAS NO DAMAGED NOTED ON THE SDS. THERE WAS CLEAR CRIMP/BAKE IMPRESSIONS ON THE BALLOON. THE BALLOON WAS NOT INFLATED. THE SDS CATHETER TIP WAS DAMAGED. FIVE SEGMENTS ON ONE END OF THE STENT WERE NOT DEFORMED OR STRETCHED. THE REMAINING STENT SEGMENTS WERE SEVERELY STRETCHED. THE CRIMP/BAKE IMPRESSIONS EVIDENT ON THE BODY OF THE BALLOON INDICATE THAT THE STENT WAS CORRECTLY CRIMPED ON TO THE BALLOON DURING MANUFACTURING. THE DEVICE WAS NOT BEEN IDENTIFIED AS THE ROOT CAUSE OF THE EVENT. THEREFORE, THE ROOT CAUSE OF THE EVENT IS UNDETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT OTW NIQ MEDTRONIC CARDIOVASCULAR GALWAY NA 0000576987

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK