BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

    MDR report key: 2161669 · Received July 14, 2011

    Report

    Report Number
    2134265-2011-02703
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Date of Event
    June 14, 2011
    Report Date
    June 16, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MDR WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: EXAMINATION OF THE RETURNED DEVICE REVEALED THERE WAS A BLOOD LIKE SUBSTANCE IN THE GUIDE WIRE LUMEN. THE BALLOON WAS TIGHTLY FOLDED AND HAD CRIMP MARKS BETWEEN THE MARKERBANDS, WHICH CONFIRMS THAT THE STENT WAS APPROPRIATELY POSITIONED AND SECURED TO THE BALLOON IN MANUFACTURING. THE STENT BECAME DETACHED WHEN RECEIVING THE COMPLAINT DEVICE. THERE WERE STRETCHED STRUTS THROUGHOUT THE MAJORITY OF THE STENT IMPLANT. THE DISTAL TIP WAS DAMAGED. 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 AND STENT MOVED ON THE STENT DELIVERY BALLOON OCCURRED. STENT THROMBOSIS WAS IDENTIFIED TWO DAYS POST THE IMPLANTATION OF A NON-BSC STENT IN THE CIRCUMFLEX. THE MODERATELY TORTUOUS TARGET LESION WAS LOCATED IN THE OSTIAL CIRCUMFLEX. THE PHYSICIAN ATTEMPTED TO PLACE THE 16MM X 2.50MM ION STENT PROXIMAL TO THE PREVIOUSLY DEPLOYED NON-BSC STENT, BUT WAS UNABLE TO CROSS THE PROXIMAL PORTION OF THE LESION; DESPITE USE OF EXCESSIVE FORCE. DURING WITHDRAWAL, THE STENT BECAME CAUGHT ON THE NON-BSC STENT CAUSING THE STRUTS TO LIFT AND PULLING THE STENT SLIGHTLY OFF THE BALLOON. UPON REMOVAL OF THE STENT DELIVERY SYSTEM THE DAMAGED STENT WAS STILL ON THE DELIVERY BALLOON. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH BALLOON ANGIOPLASTY. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CURRENT CONDITION IS OK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, STENT DAMAGE AND STENT MOVED ON THE STENT DELIVERY BALLOON OCCURRED. STENT THROMBOSIS WAS IDENTIFIED TWO DAYS POST THE IMPLANTATION OF A NON-BSC STENT IN THE CIRCUMFLEX. THE MODERATELY TORTUOUS TARGET LESION WAS LOCATED IN THE OSTIAL CIRCUMFLEX. THE PHYSICIAN ATTEMPTED TO PLACE THE 16MM X 2.50MM ION STENT PROXIMAL TO THE PREVIOUSLY DEPLOYED NON-BSC STENT, BUT WAS UNABLE TO CROSS THE PROXIMAL PORTION OF THE LESION; DESPITE USE OF EXCESSIVE FORCE. DURING WITHDRAWAL, THE STENT BECAME CAUGHT ON THE NON-BSC STENT CAUSING THE STRUTS TO LIFT AND PULLING THE STENT SLIGHTLY OFF THE BALLOON. UPON REMOVAL OF THE STENT DELIVERY SYSTEM THE DAMAGED STENT WAS STILL ON THE DELIVERY BALLOON. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH BALLOON ANGIOPLASTY. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CURRENT CONDITION IS OK.

    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 H7493902416250 14321018

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR