BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2180670 · Received May 5, 2011

    Report

    Report Number
    9612164-2011-00375
    Event Type
    Malfunction
    Date Received
    May 5, 2011
    Date of Event
    April 4, 2011
    Report Date
    April 6, 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: (STENT DAMAGE, FAILURE TO DELIVER STENT), (90% STENOSIS, SEVERE CALCIFICATION). CONCLUSIONS: (90% STENOSIS, SEVERE CALCIFICATION). EVAL SUMMARY: THE STENT HAD MOVE DISTALLY ON THE BALLOON WITH THE 1ST DISTAL STENT SEGMENT OVERLAPPING THE DISTAL INNER SHAFT MARKER. A NUMBER OF STRUTS OF THE 5TH, 6TH AND 7TH PROXIMAL SEGMENTS WERE DAMAGED, RAISED AND PULLED DISTALLY. A NUMBER OF STRUTS ON THE 3RD PROXIMAL SEGMENT WERE PARTIALLY DEFORMED. THE DISTAL TIP WAS SLIGHTLY FRAYED INDICATING THAT IT MAY HAVE BEEN STUBBED DURING ADVANCEMENT. THE BALLOON FOLDS ON THE PROXIMAL PILLOW WERE PARTIALLY OPENED AND DISTURBED.

    Description of Event or Problem · 1

    AN ENDEAVOR SPRINT RX DRUG-ELUTING STENT, LENGTH 12MM, DIAMETER 2.75MM, WAS INTENDED TO TREAT A 90% STENOSED, SEVERELY CALCIFIED LESION IN A PT. IT WAS REPORTED THAT THE DEVICE COULD NOT BE ADVANCED ACROSS THE LESION AND, ON REMOVAL, THE STENT STRUTS APPEARED DAMAGED. THE LESION WAS PRE-DILATED TWICE WITH A 2.5 X 15MM BALLOON. NO PT INJURY OCCURRED AND NO CLINICAL SEQUELAE HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX CORONARY STENT SYSTEM NIQ MEDTRONIC IRELAND NA 0002966639

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK