BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

    MDR report key: 2111036 · Received June 2, 2011

    Report

    Report Number
    2134265-2011-01940
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    May 4, 2011
    Report Date
    May 4, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE TAXUS ELEMENT/ ION STENT DELIVERY SYSTEM (SDS) WAS RECEIVED WITH CONTRAST IN THE INFLATION LUMEN AND BLOOD IN THE WIRE LUMEN AND ON THE OUTER SURFACES OF THE DEVICE. THE STENT WAS LOOSE IN THE RETURNED PACKAGING. THERE WERE STENT STRUT IMPRESSIONS BETWEEN THE MARKERBANDS ON THE SURFACE OF THE TIGHTLY FOLDED BALLOON. THE MOUTH OF THE DISTAL TIP WAS SLIGHTLY BENT. THERE WAS NO OTHER DAMAGE OR IRREGULARITIES RELATED TO THE SDS. THE ENTIRE LENGTH OF THE STENT WAS MANGLED AND STRETCHED. THE LENGTH OF THE DAMAGED STENT WAS 29 MM. THERE WAS NO EVIDENCE OF ANY PRODUCT QUALITY DEFICIENCIES CONTRIBUTING TO THE COMPLAINT EVENT. 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

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY ARTERY TREATMENT PROCEDURE STENT DISLODGEMENT OCCURRED. THE LESION BEING TREATED WAS A CALCIFIED LESION WITH PRIOR STENTS, TYPE UNKNOWN, LOCATED IN THE RIGHT CORONARY ARTERY. THE PHYSICIAN PREDILATED THE LESION WITH A 3.5X15MM APEX BALLOON. THE PHYSICIAN IMPLANTED A 4.0X38MM ION STENT AFTER USING A BUDDY WIRE WITH A NON BSC WIRE. THE PHYSICIAN WANTED TO STENT PROXIMAL TO THIS STENT, AND ATTEMPTED TO PLACE A 4.00X16MM ION STENT IN THE LESION BUT WAS UNABLE TO DELIVER THE STENT. UPON PULL BACK OF THE STENT DELIVERY SYSTEM THE STENT CAME OFF THE BALLOON. THEY WERE ABLE TO SUCCESSFULLY SNARE THE DISLODGED STENT OUT OF THE PATIENT. THE PHYSICIAN THEN SUCCESSFULLY IMPLANTED A 4.0X12 ION STENT WITH NO COMPLICATIONS. THE PATIENT CONDITION IS REPORTED AS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY ARTERY TREATMENT PROCEDURE STENT DISLODGEMENT OCCURRED. THE LESION BEING TREATED WAS A CALCIFIED LESION WITH PRIOR STENTS, TYPE UNKNOWN, LOCATED IN THE RIGHT CORONARY ARTERY. THE PHYSICIAN PREDILATED THE LESION WITH A 3.5X15MM APEX BALLOON. THE PHYSICIAN IMPLANTED A 4.0X38MM ION STENT AFTER USING A BUDDY WIRE WITH A NON BSC WIRE. THE PHYSICIAN WANTED TO STENT PROXIMAL TO THIS STENT, AND ATTEMPTED TO PLACE A 4.00X16MM ION STENT IN THE LESION BUT WAS UNABLE TO DELIVER THE STENT. UPON PULL BACK OF THE STENT DELIVERY SYSTEM THE STENT CAME OFF THE BALLOON. THEY WERE ABLE TO SUCCESSFULLY SNARE THE DISLODGED STENT OUT OF THE PATIENT. THE PHYSICIAN THEN SUCCESSFULLY IMPLANTED A 4.0X12 ION STENT WITH NO COMPLICATIONS. THE PATIENT CONDITION IS REPORTED AS 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 H7493902416400 14067487

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention KINETIX| PROWATER WIRE| 3.5X15MM APEX BALLOON CATHETER| 4.0X38MM ION STENT