BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR RESOLUTE RX

    MDR report key: 3230927 · Received July 17, 2013

    Report

    Report Number
    9612164-2013-00721
    Event Type
    Injury
    Date Received
    July 17, 2013
    Date of Event
    June 19, 2013
    Report Date
    June 19, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION, RESULTS: INHERENT RISK OF PROCEDURE ¿ (STENT DISLODGEMENT); PATIENT¿S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (LESION MORPHOLOGY) ¿ SEVERE STENOSIS AND CALCIFICATION. DEFORMATION EVALUATION, CONCLUSIONS: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (LESION MORPHOLOGY) ¿ SEVERE STENOSIS AND CALCIFICATION. INHERENT RISK OF PROCEDURE - (STENT DISLODGEMENT) (B)(4).

    Description of Event or Problem · 1

    PHYSICIAN WAS ATTEMPTING TO DEPLOY ONE ENDEAVOR RESOLUTE DRUG-ELUTING STENT TO SEVERELY CALCIFIED LESION IN THE LM-LCX WITH SEVERE STENOSIS. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ABNORMALITY NOTED. THE LESION WAS PREDILATED; HOWEVER, DIFFICULTIES WERE ENCOUNTERED DURING ADVANCEMENT OF THE ENDEAVOR RESOLUTE DEVICE TO TARGET LESION AND THE STENT DISLODGED. PHYSICIAN WITHDREW THE DISLODGED STENT AND GAVE UP SURGERY. NO PATIENT COMPLAINT WAS REPORTED. EVALUATION SUMMARY: THE DELIVERY SYSTEM WAS RETURNED WITHOUT THE STENT. CRIMP IMPRESSIONS WERE EVIDENT ALONG THE BALLOON. THE DISTAL TIP WAS DAMAGED. PLEASE NOTE THAT THIS DEVICE (ENDEAVOR RESOLUTE) IS DISTRIBUTED OUTSIDE THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE UNITED STATES DISTRIBUTED PRODUCT (RESOLUTE INTEGRITY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331752 ENDEAVOR RESOLUTE RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0006507559

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Required Intervention