BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

    MDR report key: 2223118 · Received August 25, 2011

    Report

    Report Number
    2134265-2011-03551
    Event Type
    Injury
    Date Received
    August 25, 2011
    Date of Event
    July 30, 2011
    Report Date
    July 30, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. PATIENT AGE AT TIME OF EVENT: 50S. (B)(4) - THE COMPLAINT DEVICE WAS NOT RECEIVED AT THE COMPLAINT INVESTIGATION SITE (CIS) FOR ANALYSIS. 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).

    Description of Event or Problem · 1

    SAME CASE AS MFR ID # 2134265-2011-03555. IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY TWO STENT DISLODGEMENTS OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA). THE 2.5X28MM ION STENT WAS ADVANCED TO THE RCA BUT WAS UNABLE TO CROSS A PREVIOUSLY PLACED STENT. THE PHYSICIAN ATTEMPTED TO PULL BACK THE STENT DELIVERY SYSTEM (SDS) AND NOTICED THAT THE STENT HAD MOVED ON THE BALLOON. THE PHYSICIAN REMOVED THE SDS WITH THE GUIDEWIRE, AND THE STENT DISLODGED IN THE SHEATH. THE SHEATH WAS REMOVED FROM THE PATIENT AND THE STENT WAS RECOVERED FROM THE SHEATH. THE 4.0X8MM ION STENT WAS ADVANCED TO THE RCA AND THE STENT DISLODGED PRIOR TO DEPLOYMENT. THE PHYSICIAN LOCATED THE AND CRUSHED THE EMBOLIZED STENT WITH A PROMUS STENT IN THE POSTERIOR DESCENDING ARTERY (PDA). PROCEDURE WAS COMPLETED WITH A PROMUS STENT. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493902408400 13984494

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention