BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLSTENT (ILIAC, TIPS, VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM

    MDR report key: 2231675 · Received September 1, 2011

    Report

    Report Number
    2134265-2011-03637
    Event Type
    Injury
    Date Received
    September 1, 2011
    Date of Event
    August 5, 2011
    Report Date
    August 8, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    MAF
    PMA / PMN Number
    P980033
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. 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 FURTHER REPORTED THAT THE TARGET LESION WAS 90% RESTONOSED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE IN-STENT RESTENOSIS OCCURRED. A WALLSTENT HAD BEEN IMPLANTED IN THE "AVG VEINSIDE ANASTAMOSIS" ON AN UNSPECIFIED DATE. IN AUGUST 2011 THE PATIENT RETURNED AND IN-STENT RESTENOSIS WAS DISCOVERED. THE RESTENOSIS WAS LOCATED WITHIN THE WALLSTENT AND THE STENT EDGE IN THE LEFT BRACHIAL SHUNT OF THE ULNAR ARTERY. A 6F NON BSC STENT WAS INSERTED 7CM PROXIMAL TO THE RESTENOSED WALLSTENT. A 014-135 TRANSEND GUIDE WIRE WAS ADVANCED AND EASILY CROSSED THE TARGET LESION. NEXT A 6.0-4/4T/40 SYMMETRY BALLOON CATHETER WAS ADVANCED, HOWEVER THE TIP OF THE DEVICE BUMPED INTO THE EDGE OF THE PREVIOUSLY IMPLANTED WALLSTENT AND WAS UNABLE TO CROSS THE TARGET LESION. THE SYMMETRY BALLOON CATHETER WAS REMOVED AND REPLACED WITH A STERLING BALLOON CATHETER THAT SUCCESSFULLY CROSSED THE TARGET LESION AND THE PROCEDURE WAS COMPLETED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLSTENT (ILIAC, TIPS, VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM STENT, CORONARY MAF BOSTON SCIENTIFIC - GALWAY UNK679

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention