BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

    MDR report key: 2142263 · Received June 28, 2011

    Report

    Report Number
    2134265-2011-02612
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    June 10, 2011
    Report Date
    June 14, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: RETURNED PRODUCT CONSISTED OF AN ION STENT DELIVERY SYSTEM (SDS) WITH THE SHELF BOX. THE BALLOON WAS TIGHTLY FOLDED WITH THE STENT IMPLANT SECURE BETWEEN THE MARKERBANDS. FOUR STRUTS IN THE FIRST DISTAL ROW WERE STRETCHED DISTALLY. THERE WAS NO OTHER DAMAGE TO THE DEVICE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED HANDLING DAMAGE AS THE EVENT OCCURRED PRIOR TO PATIENT CONTACT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A STENTING TREATMENT PROCEDURE STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). WHEN THE PHYSICIAN PULLED THE 3.00X12MM ION STENT DELIVERY SYSTEM (SDS) OUT OF THE PACKAGE THE STENT LOOKED DAMAGED. THE DEVICE WAS PUT TO THE SIDE AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A STENTING TREATMENT PROCEDURE STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). WHEN THE PHYSICIAN PULLED THE 3.00X12MM ION STENT DELIVERY SYSTEM (SDS) OUT OF THE PACKAGE THE STENT LOOKED DAMAGED. THE DEVICE WAS PUT TO THE SIDE AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS REPORTED.

    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 H7493902312300 14265409

    Patients

    Seq Age Sex Outcome Treatment
    1