BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR RESOLUTE RX CORONARY STENT SYSTEM

    MDR report key: 2160212 · Received June 2, 2011

    Report

    Report Number
    9612164-2011-00519
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    April 28, 2011
    Report Date
    May 6, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: STENT DAMAGE, FAILURE TO DELIVER THE STENT. RESULTS/CONCLUSIONS: TORTUOUS AND SEVERELY CALCIFIED VESSEL, 80% STENOSIS. METHODS: FILM. EVAL SUMMARY: THE DEVICE WAS RETURNED TO THE MFG FACILITY FOR EVAL. THE DISTAL TIP WAS SLIGHTLY FRAYED. THE TRANSITION TUBING AND DISTAL SHAFT APPEARED STRETCHED. THE STENT WAS DISPLACED DISTALLY LEAVING THE SECOND DISTAL SEGMENT POSITIONED OVER THE DISTAL INNER SHAFT MARKER. THE FIRST NINE DISTAL STENT SEGMENTS WERE INTACT. THE REMAINING SEGMENTS WERE BUNCHED AND DISPLACED DISTALLY ON THE BALLOON. THERE WERE CRIMP IMPRESSIONS EVIDENT ON THE EXPOSED PROXIMAL SECTION OF THE BALLOON. THE BALLOON FOLDS ON THE PROXIMAL SECTION OF THE BALLOON AND PILLOW WERE PARTIALLY OPENED. CINE IMAGE REVIEW: THE CD IMAGES CONFIRM THE TORTUOUS AND CALCIFIED NATURE OF THE LESION. DESPITE NUMEROUS PRE-DILATIONS, IT APPEARS THAT THE PHYSICIAN WAS UNABLE TO ADVANCE THE STENT ACROSS THE LESION. IT APPEARS THAT POST REMOVAL OF THE ENDEAVOR RESOLUTE DEVICE, THE PHYSICIAN COMPLETED FURTHER BALLOONING OF THE VESSEL. PLEASE NOTE THAT THIS DEVICE (B)(4) IS DISTRIBUTED OUTSIDE THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE UNITED STATES DISTRIBUTED PRODUCT (B)(4).

    Description of Event or Problem · 1

    THE PHYSICIAN WAS ATTEMPTING TO IMPLANT A 2.25 MM DIAMETER X 24 MM LENGTH ENDEAVOR RESOLUTE RAPID EXCHANGE (RX) DRUG-ELUTING STENT TO TREAT A LESION. THE TARGET LESION WAS TORTUOUS WITH SEVERE CALCIFICATION AND 80% STENOSIS. THE LESION WAS PRE-DILATED ONCE USING AT 2.0 X 20 MM BALLOON. WHILE ATTEMPTING TO CROSS THE LESION, IT WAS OBSERVED THAT SOME STENT STRUTS WERE DAMAGED. NO CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR RESOLUTE RX CORONARY STENT SYSTEM NIQ MEDTRONIC IRELAND NA 0005210318

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK