BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS PREMIER?

    MDR report key: 3881569 · Received June 18, 2014

    Report

    Report Number
    2134265-2014-03419
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    May 16, 2014
    Report Date
    May 20, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: THE BALLOON CONES PROFILES WERE REVIEWED AND NO ISSUES WERE NOTED WITH THE OVERALL BALLOON PROFILE. THE CRIMPED STENT WAS DETACHED FROM BALLOON AND NOT RETURNED WITH DEVICE FOR ANALYSIS. CRIMP MARKINGS WERE EVIDENT ON THE WALL OF THE BALLOON. A VISUAL AND TACTILE EXAMINATION FOUND MULTIPLE KINKS ON HYPOTUBE. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE FORCE BEING APPLIED TO THE DELIVERY SYSTEM. THE BUMPER TIP OF THE DEVICE SHOWED NO SIGNS OF DAMAGE. A VISUAL AND TACTILE EXAMINATION FOUND NO ISSUES WITH THE PROFILE OF THE SHAFT. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE LESION IS LOCATED IN THE MODERATELY CALCIFIED DIAGONAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 2.25X24MM PROMUS PREMIER STENT WAS SELECTED AND ADVANCED TO THE LESION. DURING THE PROCEDURE, THE PATIENT STARTED TO GET "HEMODYNAMICALLY UNSTABLE". THE USER PULLED THE DEVICE BACK QUICKLY BUT IT WAS NOTED THAT THE STENT GOT STUCK ONTO THE GUIDE AND THE STENT CAME OFF INTO THE GUIDE WHICH WAS HANGING ON THE GUIDE AREA DISTAL TO THE HUB. THE DEVICE WAS REMOVED FROM THE PATIENT. PREDILATATION WAS PERFORMED USING A UNSPECIFIED BALLOON. A NON-BSC GUIDE CATHETER AND GUIDEWIRE WAS INTRODUCED. THE PROCEDURE WAS COMPLETED WITH AN UNSPECIFIED 2.25 X 28 STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE LESION IS LOCATED IN THE MODERATELY CALCIFIED DIAGONAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 2.25X24MM PROMUS PREMIER¿ STENT WAS SELECTED AND ADVANCED TO THE LESION. DURING THE PROCEDURE, THE PATIENT STARTED TO GET "HEMODYNAMICALLY UNSTABLE". THE USER PULLED THE DEVICE BACK QUICKLY BUT IT WAS NOTED THAT THE STENT GOT STUCK ONTO THE GUIDE AND THE STENT CAME OFF INTO THE GUIDE WHICH WAS HANGING ON THE GUIDE AREA DISTAL TO THE HUB. THE DEVICE WAS REMOVED FROM THE PATIENT. PREDILATATION WAS PERFORMED USING A UNSPECIFIED BALLOON. A NON-BSC GUIDECATHETER AND GUIDEWIRE WAS INTRODUCED. THE PROCEDURE WAS COMPLETED WITH AN UNSPECIFIED 2.25 X 28 STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357352 PROMUS PREMIER? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493952824220 16735344

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR GUIDE CATHETER: XBLAD BY CORDIS