BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR RESOLUTE RX CORONARY STENT SYSTEM

    MDR report key: 2092783 · Received May 10, 2011

    Report

    Report Number
    9612164-2011-00400
    Event Type
    Injury
    Date Received
    May 10, 2011
    Date of Event
    February 24, 2011
    Report Date
    April 12, 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
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION: RESULTS: VESSEL DISSECTION, FAILURE TO DELIVER STENT AND STENT DEFORMATION. PATIENT LESION MORPHOLOGY SEVERELY CALCIFIED. NO CONCLUSION CAN BE DRAWN, ROOT CAUSE OF EVENT IS UNDETERMINED. EVALUATION: CONCLUSION: NO CONCLUSION CAN BE DRAWN, ROOT CAUSE OF EVENT IS UNDETERMINED. PATIENT LESION MORPHOLOGY SEVERELY CALCIFIED. EVALUATION SUMMARY: A NUMBER OF STRUTS ON THE 8TH, 9TH, AND 11TH STENT SEGMENT WERE PARTIALLY RAISED AND DEFORMED. THE DISTAL TIP WAS SLIGHTLY FRAYED. 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 DEPLOY A 3.0 MM DIAMETER X 18MM LENGTH ENDEAVOR RESOLUTE RAPID EXCHANGE (RX) DRUG ELUTING STENT IN A PATIENT TO TREAT A LESION IN THE LAD THAT WAS SEVERLY CALCIFIED. INFORMATION RECEIVED INDICATED THAT WHILE ATTEMPTING TO DELIVER THE STENT TO THE LESION, A DISSECTION OCCURRED. THE DISSECTION WAS SUCCESSFULLY TREATED BY DEPLOYING ANOTHER STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR RESOLUTE RX CORONARY STENT SYSTEM NIQ MEDTRONIC IRELAND NA 0004688181

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention