BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2190280 · Received July 21, 2011

    Report

    Report Number
    9612164-2011-00804
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    June 17, 2011
    Report Date
    June 22, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVALUATION RESULTS: (CALCIFICATION), (FAILURE TO DELIVER THE STENT AND STENT DISLODGEMENT). CONCLUSION: (CALCIFICATION). EVALUATION SUMMARY: THE HYPOTUBE WAS BENT AND KINKED DISTAL TO THE STRAIN RELIEF. CRIMP IMPRESSIONS WERE EVIDENT ON THE BALLOON. ALL THE STENT SEGMENTS WERE DAMAGED AND DEFORMED. THE DISTAL TIP WAS SLIGHTLY FLARED.

    Description of Event or Problem · 1

    AN ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG-ELUTING STENT WAS BEING USED FOR TREATMENT OF A LESION. THE ENDEAVOR SPRINT RX DISLODGED FROM THE DELIVERY SYSTEM AS IT PASSED THROUGH A CALCIFIED AREA BEFORE IT REACHED THE TARGET LESION. AN ATTEMPT WAS THEN MADE TO PULL THE UNDEPLOYED STENT BACK INTO THE GUIDE CATHETER WITH A RETRIEVAL DEVICE. THE STENT WAS PULLED BACK AS FAR AS THE RADIAL ARTERY WHERE IT WAS SURGICALLY REMOVED. THE LESION WAS PRE-DILATED BEFORE USE, NO ABNORMALITIES WERE NOTED DURING PREP AND INSPECTION PRIOR TO USE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX CORONARY STENT SYSTEM NIQ MEDTRONIC IRELAND NA 0001132839

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention