BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR RESOLUTE RX

    MDR report key: 3801932 · Received May 9, 2014

    Report

    Report Number
    9612164-2014-00505
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Date of Event
    February 18, 2014
    Report Date
    April 10, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: PATIENT¿S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (LESION MORPHOLOGY). RELATED TO OPERATIONAL CONTEXT (PROCEDURAL RELATED). FAILURE TO FOLLOW INSTRUCTIONS (FORCE USED). EVALUATION CONCLUSIONS: DEVICE FAILURE RELATED TO PATIENT CONDITION (LESION MORPHOLOGY). OPERATIONAL CONTEXT CAUSED OR CONTRIBUTED TO THE EVENT (PROCEDURAL RELATED). FAILURE TO FOLLOW INSTRUCTIONS (FORCE USED). (B)(4).

    Description of Event or Problem · 1

    IT WAS INTENDED TO USE AN ENDEAVOR RESOLUTE RX DRUG ELUTING STENT TO TREAT A LESION IN THE CX VESSEL. THE VESSEL TO BE TREATED WAS DESCRIBED AS CALCIFIED, NON TORTUOUS AND HAD 70% STENOSIS. THE PHYSICIAN PRE-DILATED THE LESION WITH A NON MEDTRONIC 2.00 X 15 MM BALLOON AND ATTEMPTED TO POSITION THE STENT. NO DIFFICULTIES WERE EXPERIENCED LOADING THE DEVICE ONTO THE GUIDEWIRE. THE STENT FAILED TO BE POSITIONED, FORCE WAS USED IN AN ATTEMPT TO DELIVER THE DEVICE. THE PHYSICIAN THEN USED ANOTHER NON MEDTRONIC 2.25 X 20 MM BALLOON TO PRE-DILATE THE LESION, WHICH ALLOWED A GREATER DIAMETER. THE PHYSICIAN WAS ABLE TO RE-POSITION THE STENT AT THE LESION SITE, HOWEVER WHEN AN ATTEMPT WAS MADE TO INFLATE THE BALLOON, THE BALLOON FAILED TO INFLATE. THE DEVICE WAS REMOVED FROM THE PATIENT. NO REPORTED PATIENT COMPLICATIONS. EVALUATION SUMMARY: THE STENT WAS POSITIONED ON THE BALLOON BETWEEN THE INNER SHAFT MARKERS. THERE WAS NO DEFORMATION EVIDENT TO THE STENT SEGMENTS OR STRUTS .THE DISTAL INNER AND OUTER SHAFTS WERE RIPPED EXTENDING 17.1CM DISTALLY FROM THE GUIDEWIRE ENTRY PORT. THE CORE WIRE WAS EXPOSED AND EXITING THE DISTAL SHAFT. THERE WAS BLOOD VISIBLE IN THE INFLATION LUMEN AND BALLOON. NEGATIVE PREP INDICATED A LEAK. ON PRESSURIZATION OF THE DEVICE WATER WAS SEEN EXITING FROM THE RIPPED SECTION OF THE DISTAL SHAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281621 ENDEAVOR RESOLUTE RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0006680091

    Patients

    Seq Age Sex Outcome Treatment
    1