BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLGRAFT ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM

    MDR report key: 2190130 · Received August 4, 2011

    Report

    Report Number
    2134265-2011-03355
    Event Type
    Injury
    Date Received
    August 4, 2011
    Date of Event
    July 5, 2011
    Report Date
    July 6, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    JCT
    PMA / PMN Number
    K003100
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER: 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 DURING A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY TREATMENT PROCEDURE EXTRAVASATIONS OF THE STENT OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE TREATMENT WAS INDICATED FOR AN ANEURYSM LOCATED IN THE NON CALCIFIED LEFT SUBCLAVIAN ARTERY. A 9 MM X 50 MM WALLGRAFT STENT WAS SUCCESSFULLY IMPLANTED AND WAS WELL POSITIONED AND WELL APPOSED TO THE VESSEL WALL. AFTER ARTERIOGRAPHY CONTRAST EXTRAVASATION WAS OBSERVED THROUGH THE CENTRAL WALL OF THE IMPLANTED WALLGRAFT STENT. THE ISSUE WAS RESOLVED BY IMPLANTING A 8 MM. X 60 MM NON BSC STENT INSIDE THE WALLGRAFT STENT. FOLLOW UP ARTERIOGRAPHY SHOWED NO CONTRAST EXTRAVASATIONS WITHIN THE ANEURYSM. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLGRAFT ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM PROSTHESIS, TRACHEAL, EXPANDABLE JCT BOSTON SCIENTIFIC - GALWAY H965520140 14088385

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention