BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR RESOLUTE RX CORONARY STENT SYSTEM

    MDR report key: 1852153 · Received September 29, 2010

    Report

    Report Number
    2953200-2010-01848
    Event Type
    Malfunction
    Date Received
    September 29, 2010
    Date of Event
    August 26, 2010
    Report Date
    August 31, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS AND CONCLUSION: HIGHLY CALCIFIED PROXIMAL LAD, FAILURE TO DELIVER THE STENT, STENT EMBOLISM.

    Description of Event or Problem · 1

    AN ATTEMPT WAS MADE TO DEPLOY A 2.25 MM DIAMETER X 12 MM LENGTH ENDEAVOR RESOLUTE RAPID EXCHANGE CORONARY STENT IN THE DISTAL LAD WHICH EXHIBITED 85-90% STENOSIS. IT WAS REPORTED THAT THE RELEVANT DEVICE WOULD NOT CROSS THE PROXIMAL LAD WHICH WAS HIGHLY CALCIFIED. AFTER SEVERAL PRE-DILATIONS THE RESULT DID NOT CHANGE AND THE STENT DISLODGED FROM THE DELIVERY SYSTEM DURING ATTEMPTS TO PASS. ATTEMPTS TO RETRIEVE THE STENT FAILED; HOWEVER, THE PHYSICIAN DECIDED TO LEAVE IT SINCE THERE WAS NO EFFECT ON BLOOD FLOW AND THE PATIENT WAS STABLE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED. PLEASE NOTED THAT THIS DEVICE (B)(4) IS DISTRIBUTED OUTSIDE THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE UNITED STATES DISTRIBUTED PRODUCT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR RESOLUTE RX CORONARY STENT SYSTEM NIQ MEDTRONIC CARDIOVASCULAR GALWAY NA 0000949086

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK