BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLGRAFT TRACHEOBRONCHIAL ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM

    MDR report key: 2071730 · Received April 28, 2011

    Report

    Report Number
    2134265-2011-01332
    Event Type
    Injury
    Date Received
    April 28, 2011
    Date of Event
    March 18, 2011
    Report Date
    March 31, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    JCT
    PMA / PMN Number
    K003100
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: (B)(6). 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

    SAME CASE AS MFR#: 2134265-2011-01330. IT WAS REPORTED THAT POST A PERIPHERAL STENTING TREATMENT PROCEDURE, THE STENTS RESTENOSED. AN UNKNOWN SIZED WALLSTENT AND AN UNKNOWN SIZED WALLGRAFT WERE IMPLANTED OVERLAPPING ON AN UNKNOWN DATE IN THE PATIENT¿S LEFT ARM. POST PROCEDURE, THE PATIENT RETURNED AND THE STENTS WERE NOTED TO BE 70% RESTENOSED. AN ULTRA-THIN DIAMOND BALLOON CATHETER WAS ADVANCED AND DURING THE FIRST INFLATION, THE BALLOON RUPTURED AT 12ATMS. A SECOND ULTRA-THIN DIAMOND BALLOON WAS ADVANCED, BUT THE SHAFT 'ACCORDIONED' WHILE ATTEMPTING TO ADVANCE IT THROUGH A NON BSC SHEATH. THE LESION WAS SUCCESSFULLY TREATED WITH A THIRD ULTRA-THIN DIAMOND BALLOON. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS FINE. THE RUPTURE OF THE FIRST ULTRA-THIN DIAMOND BALLOON WAS REPORTED ON THE ALTERNATIVE SUMMARY REPORT SUBMITTED FOR QUARTER 1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLGRAFT TRACHEOBRONCHIAL ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM PROSTHESIS, TRACHEAL, EXPANDABLE JCT BOSTON SCIENTIFIC - GALWAY UNK478

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention