BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ION?

    MDR report key: 3242468 · Received July 23, 2013

    Report

    Report Number
    2134265-2013-04904
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    June 24, 2013
    Report Date
    June 24, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AGE AT THE TIME OF EVENT: 18 YEARS OR OLDER. DEVICE IS COMBINATION PRODUCT. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE STENT WAS DAMAGED AT THE PROXIMAL END. STRUTS ON THE MOST PROXIMAL ROW WERE BENT OUTWARDS. SOME STRUTS ON THE SECOND ROW WERE SLIGHTLY MISALIGNED AS A RESULT. THE HYPOTUBE WAS KINKED AT VARIOUS LOCATIONS ALONG ITS LENGTH. 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

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE LESION BEING TREATED WAS LOCATED IN THE SEVERELY TORTUOUS RIGHT CORONARY ARTERY. THE PHYSICIAN PREDILATED THE TARGET LESION. THEN, THE PHYSICIAN ADVANCED A 3.50 X 16 MM ION STENT DELIVERY SYSTEM (SDS) THROUGH THREE PREVIOUSLY IMPLANTED TAXUS STENTS AND WAS NOT ABLE TO CROSS THE LESION. THE DEVICE WAS SUCCESSFULLY REMOVED. THE PHYSICIAN READVANCED THE SDS USING A EXTENSION GUIDE CATHETER AND MULTIPLE GUIDE WIRES AND WAS STILL UNABLE TO CROSS THROUGH THE IMPLANTED STENTS. THE SDS WAS SUCCESSFULLY REMOVED IT WAS NOTED THAT PROXIMAL STENT DAMAGE HAD OCCURRED. THE PROCEDURE WAS COMPLETED WITH A 3.0 X 16 MM ION STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT¿S STATUS IS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE LESION BEING TREATED WAS LOCATED IN THE SEVERELY TORTUOUS RIGHT CORONARY ARTERY. THE PHYSICIAN PREDILATED THE TARGET LESION. THEN, THE PHYSICIAN ADVANCED A 3.50X16MM ION STENT DELIVERY SYSTEM (SDS) THROUGH THREE PREVIOUSLY IMPLANTED TAXUS STENTS AND WAS NOT ABLE TO CROSS THE LESION. THE DEVICE WAS SUCCESSFULLY REMOVED. THE PHYSICIAN READVANCED THE SDS USING A EXTENSION GUIDE CATHETER AND MULTIPLE GUIDE WIRES AND WAS STILL UNABLE TO CROSS THROUGH THE IMPLANTED STENTS. THE SDS WAS SUCCESSFULLY REMOVED IT WAS NOTED THAT PROXIMAL STENT DAMAGE HAD OCCURRED. THE PROCEDURE WAS COMPLETED WITH A 3.0X16MM ION STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT¿S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342810 ION? CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493902416350 15017669

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDELINER EXTENSION CATHETER