BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

    MDR report key: 2211395 · Received August 15, 2011

    Report

    Report Number
    2134265-2011-03336
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Date of Event
    June 1, 2011
    Report Date
    July 25, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: RECEIVED PRODUCT CONSISTED OF A TAXUS ELEMENT/ION MONORAIL STENT DELIVERY SYSTEM (SDS), STENT AND CLIP-IT. THE SDS WAS COILED UP AND HELD TOGETHER WITH THE CLIP-IT. THE SHAFT OF THE DEVICE PRESENTED KINKS THROUGHOUT THE ENTIRE LENGTH AT THE LOCATION OF THE CLIP-IT. THE BALLOON WAS TIGHTLY FOLDED WITH THE STENT POSITIONED BETWEEN THE MARKERBANDS. MULTIPLE STENT STRUTS STARTING IN THE MIDDLE AND ON THE DISTAL END WERE BUNCHED. FURTHER INSPECTION PRESENTED NO OTHER DAMAGE OR IRREGULARITIES. 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 STENT DAMAGE OCCURRED. A 4.00X38MM ION STENT DELIVERY SYSTEM (SDS) WAS DAMAGED DURING EITHER PREPARATION FOR USE IN A PROCEDURE OR SUBSEQUENT TO THE PROCEDURE WHEN IT WAS FOUND ENTWINED WITH A NON-BSC GUIDE WIRE. THE DAMAGE NOTED WAS A FLARED STENT STRUT. THE 4.00X38MM ION WAS NOT USED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 4.00X38MM ION STENT DELIVERY SYSTEM (SDS) WAS DAMAGED DURING EITHER PREPARATION FOR USE IN A PROCEDURE OR SUBSEQUENT TO THE PROCEDURE WHEN IT WAS FOUND ENTWINED WITH A NON-BSC GUIDE WIRE. THE DAMAGE NOTED WAS A FLARED STENT STRUT. THE 4.00X38MM ION WAS NOT USED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS NOT AVAILABLE.

    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 H7493902438400 0014121591

    Patients

    Seq Age Sex Outcome Treatment
    1