BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2190968 · Received July 28, 2011

    Report

    Report Number
    9612164-2011-00845
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 29, 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
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVAL RESULTS: (80% STENOSED WITH ACUTE ANGLE CALCIFICATIONS), (STENT DISLODGED), (DEVICE NOT RECEIVED FOR EVAL). CONCLUSION RESULTS: (80% STENOSED WITH ACUTE ANGLE CALCIFICATIONS).

    Description of Event or Problem · 1

    AN ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG-ELUTING STENT WAS BEEN USED TO TREAT A LESION FROM LEFT MAIN TO CIRCUMFLEX (CX). THE LESION WAS 80% STENOSED WITH ACUTE ANGLE CALCIFICATIONS. THE PHYSICIAN PRE-DILATED THE LESION AND ATTEMPTED TO PLACE THE ENDEAVOR SPRINT RX STENT IN THE DESIRED LOCATION. AS THE DEVICE MADE THE TURN INTO THE CX, PART OF THE STENT GOT TRAPPED ON CALCIUM AND THE PHYSICIAN WAS UNABLE TO MOVE. THE STENT DISLODGED DURING ATTEMPTS TO MOVE THE DEVICE THROUGH THE CALCIUM. A SNARE WAS USED TO RETRIEVE THE DISLODGED STENT. THE LESION WAS TREATED SUCCESSFULLY WITH TWO SHORTER STENTS. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. THE PT IS FINE POST PROCEDURE AND NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX CORONARY STENT SYSTEM NIQ MEDTRONIC IRELAND NA 0001251248

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention