BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR RESOLUTE RX CORONARY STENT SYSTEM

    MDR report key: 1080774 · Received July 23, 2008

    Report

    Report Number
    2953200-2008-00590
    Event Type
    Injury
    Date Received
    July 23, 2008
    Date of Event
    June 23, 2008
    Report Date
    June 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
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SECONDARY INTERVENTION.

    Description of Event or Problem · 1

    A 2.75MM DIAMETER X 24 MM LENGTH ENDEAVOR RESOLUTE RX DRUG-ELUTING CORONARY STENT DELIVERY SYSTEM WAS INSERTED INTO A PATIENT FOR THE TREATMENT OF A CTO OF THE LAD. LESION MORPHOLOGY WAS REPORTED AT NON-TORTUOUS WITH LITTLE CALCIFICATION. THE LESION WAS PRE-DILATED. IT WAS REPORTED THAT THE ENDEAVOR RESOLUTE DRUG-ELUTING STENT WAS SUCCESSFULLY IMPLANTED. A SMALL DISSECTION WAS NOTED DISTAL TO THE DEPLOYED STENT. (MFR. REPORT# 2953200-2008-00589) A SECOND ENDEAVOR RESOLUTE DRUG-ELUTING STENT WAS INSERTED; HOWEVER, THE PHYSICIAN WAS UNABLE TO ADVANCED PASSED THE PREVIOUSLY DEPLOYED STENT. THE PHYSICIAN ATTEMPTED TO PULL THE DELIVERY SYSTEM BACK INTO THE GUIDE CATHETER; THE STENT CAUGHT ON THE PROXIMAL EDGE OF THE PREVIOUSLY DEPLOYED STENT. THE PHYSICIAN MADE SEVERAL ATTEMPTS AND PULLED QUITE HARD, THE DELIVERY SYSTEM WAS REMOVED WITHOUT THE STENT. THE UN-DEPLOYED STENT DISLODGED IN THE PROXIMAL LAD. IT WAS REPORTED THAT THE PHYSICIAN ATTEMPTED TO RETRIEVE THE UN-DEPLOYED STENT; HOWEVER, IT FLOATED TO THE PROFUNDA ARTERY. THE PHYSICIAN PUSHED THE UN-DEPLOYED STENT DEEPER INTO A SIDE BRANCH OF THE ARTERY WHERE IT REMAINS. A THIRD ENDEAVOR RESOLUTE DRUG-ELUTING STENT WAS SUCCESSFULLY IMPLANTED DISTAL TO THE FIRST STENT WITH 3MM OVERLAP. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE. PLEASE NOTE THAT THIS DEVICE (LOT NUMBER UNK) IS DISTRIBUTED OUTSIDE THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE UNITED STATES DISTRIBUTED PRODUCT. EVALUATION SUMMARY: MEDTRONIC HAS RECEIVED THE DEVICE AND ITS ANALYSIS HAS BEEN COMPLETED. THE STENT WAS NOT RETURNED. THERE WAS BLOOD RESIDUE EVIDENT ON THE ENTIRE DEVICE. THERE WERE SLIGHT BENDS AND TWISTS ALONG THE SHAFT. THERE WAS CLEAR EVIDENCE OF CRIMP/ BAKE IMPRESSIONS ON THE BALLOON. THE BALLOON FOLDS APPEARED SLIGHTLY DISTURBED. THE DISTAL TIP WAS DAMAGED. THE CATHETER TIP WAS FLARED. THERE WERE SLIGHT CHATTER MARKS ON THE PROXIMAL PILLOW WHICH MAY HAVE OCCURRED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR RESOLUTE RX CORONARY STENT SYSTEM NIQ MEDTRONIC CARDIOVASCULAR GALWAY NA 0000620825

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention