BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXSTENT MONORAIL

    MDR report key: 1022597 · Received April 1, 2008

    Report

    Report Number
    2134265-2008-00933
    Event Type
    Injury
    Date Received
    April 1, 2008
    Date of Event
    January 11, 2008
    Report Date
    March 6, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIM
    PMA / PMN Number
    P050025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE COMPLAINANT INDICATED THAT THE DEVICE REMAINS IN THE PATIENT AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    CLINICAL TRIAL. IT WAS REPORTED THAT DURING THE CAROTID STENTING INDEX PROCEDURE, THE NEXSTENT JUMPED AND REQUIRED A THIRD STENT TO FULLY COVER THE LESION. THE INDEX PROCEDURE TREATED A 6.5X10MM, 90% STENOSED LESION IN THE OSTIUM OF THE LEFT INTERNAL CAROTID ARTERY. PREDILATION WAS NOT PERFORMED PRIOR TO THE PLACEMENT OF THE FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM. FOLLOWING FILTERWIRE PLACEMENT, PREDILATION WAS PERFORMED. A 4-9X30MM NEXSTENT WAS THEN PLACED, HOWEVER, UPON REMOVAL OF THE FILTERWIRE, THERE WAS AN ACCORDION LIKE LESION NOTED DISTAL TO THE STENT. A SECOND SAME STENT WAS PLACED DISTAL TO THIS STENT AFTER THE ADVANCEMENT OF ANOTHER FILTERWIRE EZ SYSTEM. THE SECOND STENT JUMPED AND FORESHORTENED, LEAVING A GAP BETWEEN THE TWO STENTS. A THIRD SAME STENT WAS PLACED BETWEEN THE TWO STENTS TO FULLY COVER THE LESION. THERE WAS SOME DISTAL ACCORDION LIKE LESION DISTAL TO THE FIRST STENT. POST-DILATION WAS PERFORMED AND RESIDUAL STENOSIS WAS 5%. THERE WERE NO ADVERSE EVENTS DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXSTENT MONORAIL NIM STENT, CAROTID NIM BOSTON SCIENTIFIC NA C73105

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R