BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2152428 · Received June 21, 2011

    Report

    Report Number
    9612164-2011-00625
    Event Type
    Malfunction
    Date Received
    June 21, 2011
    Date of Event
    May 21, 2011
    Report Date
    May 24, 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
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, METHOD: FILM (X-RAY, FLUOROSCOPY, IVUS, CT, MRI, ETC). RESULTS: (STENT DISLODGEMENT AND FAILURE TO DELIVER STENT). RESULTS AND CONCLUSION: (USE OF FORCE), (DIFFUSED CALCIFIED RESISTANT STENOSIS).

    Description of Event or Problem · 1

    THE PHYSICIAN WAS ATTEMPTING TO DEPLOY A 3.0 MM DIAMETER X 24MM LENGTH ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG ELUTING STENT TO TREAT A SEVERLY CALCIFIED LESION LOCATED IN THE RCA. IT WAS REPORTED THAT THE STENT DISLODGED IN THE OSTIUM OF THE RCA. IT WAS REPORTED THAT IT WAS A DIFFICULT LESION TO TREAT AND THAT RESISTANCE WAS EXPERIENCED AND FORCE WAS USED TO DELIVER THE STENT. ANOTHER STENT WAS USED TO CRUSH THE DISLODGED STENT TO THE VESSEL WALL OF THE PT. PRIOR TO USE, THE DEVICE WAS INSPECTED AND PREPPED WITH NO ISSUES NOTED. NO PT INJURY OCCURRED AND NO CLINICAL SEQUELAE WERE REPORTED. CINE IMAGES: PROCEDURAL IMAGES WERE PROVIDED WHICH CONFIRMED THE PRE-DILATATION OF THE MID AND PROXIMAL RCA. THE IMAGES ALSO CONFIRMED THAT THE VESSEL WAS DIFFUSELY CALCIFIED AND STENOTIC. THE IMAGES CLEARLY SHOW A DISLODGED STENT AT THE OSTIUM OF THE RCA. THIS STENT WAS CRUSHED AGAINST THE VESSEL WITH BALLOONING AND WITH STENT DEPLOYMENT. FOUR OVERLAPPING STENTS APPEAR TO HAVE BEEN DEPLOYED FROM THE OSTIUM OF THE RCA TO THE MID VESSEL. EXTENSIVE POST DILATATION ACTIVITIES WERE COMPLETED TO ENSURE THAT ALL STENTS WERE FULLY APPOSED TO THE VESSEL WALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX CORONARY STENT SYSTEM NIQ MEDTRONIC IRELAND NA 0005574468

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention