BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ION¿

    MDR report key: 2191844 · Received August 4, 2011

    Report

    Report Number
    2134265-2011-03092
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    July 8, 2011
    Report Date
    July 8, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE ION SDS WAS RETURNED LOADED IN THE GUIDE CATHETER, WITH THE Y-ADAPTOR CONNECTED TO THE GUIDE CATHETER, AND THE GUIDEWIRE IN THE LUMEN OF THE COMPLAINT DEVICE. THE PROXIMAL END OF THE STENT HAD SEVERAL PROXIMAL STENT STRUTS RAISED AND OVERLAPPING. AN ATTEMPT TO SEPARATE THE ION FROM THE GUIDE CATHETER WAS UNSUCCESSFUL DUE TO THE SEVERE DAMAGE TO THE STENT. THERE WAS A WHITE FIBROUS FOREIGN MATERIAL (FM) INTERTWINED IN THE STENT IMPLANT. AN ATTEMPT WAS MADE TO REMOVE FM TO BE TESTED, BUT WAS UNABLE TO OBTAIN A LARGE ENOUGH SAMPLE TO BE TESTED. 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 DURING A STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED RIGHT CORONARY ARTERY (RCA). A NON-BSC GUIDE CATHETER ENGAGED THE VESSEL AND A CHOICE EXTRA SUPPORT GUIDE WIRE WAS ADVANCED. NEXT, A 28X3.0MM ION STENT DELIVERY SYSTEM (SDS) WAS ADVANCED BUT COULD NOT CROSS THE TARGET LESION. UPON REMOVING THE SDS, THE STENT GOT CAUGHT AND FLARED. THE GUIDE CATHETER, GUIDE WIRE AND STENT WERE REMOVED TOGETHER. BALLOON ANGIOPLASTY WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED RIGHT CORONARY ARTERY (RCA). A NON-BSC GUIDE CATHETER ENGAGED THE VESSEL AND A CHOICE EXTRA SUPPORT GUIDE WIRE WAS ADVANCED. NEXT, A 28X3.0MM ION STENT DELIVERY SYSTEM (SDS) WAS ADVANCED BUT COULD NOT CROSS THE TARGET LESION. UPON REMOVING THE SDS, THE STENT GOT CAUGHT AND FLARED. THE GUIDE CATHETER, GUIDE WIRE AND STENT WERE REMOVED TOGETHER. BALLOON ANGIOPLASTY WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ION¿ CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493902428300 14046404

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR CHOICE EXTRA SUPPORT GUIDE WIRE| MEDTRONIC 6FR EBU GUIDE