BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2102872 · Received May 3, 2011

    Report

    Report Number
    9612164-2011-00353
    Event Type
    Malfunction
    Date Received
    May 3, 2011
    Date of Event
    March 30, 2011
    Report Date
    April 4, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS: (FAILURE TO DELIVER STENT), (80% STENOSIS), (FAILURE TO PRE-DILATE). CONCLUSIONS: (80% STENOSIS), (FAILURE TO PRE-DILATE). EVAL SUMMARY: THE STENT WAS POSITIONED ON THE BALLOON AS PER SPECIFICATIONS. THE 4TH AND 5TH DISTAL STENT SEGMENTS WERE TWISTED AND OVERLAPPING. THE 6TH AND 7TH PROXIMAL STENT SEGMENTS WERE SLIGHTLY RAISED. THE DAMAGED STENT SEGMENT OD EXCEEDED SPECIFICATIONS.

    Description of Event or Problem · 1

    THE PHYSICIAN WAS ATTEMPTING TO IMPLANT A 2.75 MM DIAMETER X 18 MM LENGTH ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG-ELUTING STENT TO TREAT A LESION IN THE LAD BY DIRECT STENTING. THE TARGET LESION HAD SOME CALCIFICATION AND 80% STENOSIS. THE ENDEAVOR SPRINT DEVICE COULD NOT PASS THE LESION AND THE DEVICE WAS REMOVED. THE STRUTS OF THE STENT WERE NOTED TO BE DAMAGED. THE LESION WAS THEN PRE-DILATED ONCE USING A 2.0 MM X 20 MM BALLOON AT 14 ATM'S. SEVENTY-FIVE PERCENT STENOSIS REMAINED FOLLOWING THIS PRE-DILATION. THE DEVICE HAD BEEN INSPECTED PRIOR TO USE WITH NO ABNORMALITIES NOTED. THE TARGET LESION WAS TREATED USING ANOTHER ENDEAVOR SPRINT STENT OF THE SAME SIZE. PATIENT'S STATUS POST-PROCEDURE WAS STABLE AND NO 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 0005368293

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK