BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPRESS? LD VASCULAR

    MDR report key: 3315302 · Received August 29, 2013

    Report

    Report Number
    2134265-2013-05980
    Event Type
    Injury
    Date Received
    August 29, 2013
    Date of Event
    July 30, 2013
    Report Date
    August 5, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPN, UPN-SEARCH CORRECTED FROM UNK134 TO H74938162740750. PMA# OR 510K# CORRECTED FROM P090003 TO SIMILAR.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STENT MIGRATION AND PARTIAL STENT DEPLOYMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE COMMON ILIAC ARTERY (ARTERIA ILIACA COMMUNIS). AN EXPRESS LD STENT WAS IMPLANTED; HOWEVER, THE STENT MOVED IN A CRANIAL DIRECTION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. 3 DAYS LATER, CT ANGIOGRAPHY REVEALED THAT THE PREVIOUSLY IMPLANTED EXPRESS LD STENT WAS NOT FULLY DEPLOYED. THE PATIENT WAS SENT TO ANOTHER ANGIOGRAPHY DEPARTMENT. BALLOON ANGIOPLASTY WAS PERFORMED TO OPEN THE STENT. THE PATIENT IS OK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STENT MIGRATION AND PARTIAL STENT DEPLOYMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE COMMON ILIAC ARTERY (ARTERIA ILIACA COMMUNIS). AN EXPRESS LD STENT WAS IMPLANTED; HOWEVER, THE STENT MOVED IN A CRANIAL DIRECTION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THREE (3) DAYS LATER, CT ANGIOGRAPHY REVEALED THAT THE PREVIOUSLY IMPLANTED EXPRESS LD STENT WAS NOT FULLY DEPLOYED. THE PATIENT WAS SENT TO ANOTHER ANGIOGRAPHY DEPARTMENT. BALLOON ANGIOPLASTY WAS PERFORMED TO OPEN THE STENT. THE PATIENT IS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427722 EXPRESS? LD VASCULAR CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY H74938162740750 16132268

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention