BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALEO VASCULAR STENT

    MDR report key: 1830165 · Received September 3, 2010

    Report

    Report Number
    2020394-2010-00279
    Event Type
    Malfunction
    Date Received
    September 3, 2010
    Date of Event
    August 6, 2010
    Report Date
    August 11, 2010
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    FGE
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS WERE REVIEWED WITH SPECIAL ATTENTION TO THE RAW MATERIALS, THE SUBASSEMBLIES, THE MANUFACTURING PROCESS AND THE QUALITY CONTROL TESTING. THIS LOT MET ALL RELEASE CRITERIA. THERE WAS NOTHING FOUND IN THE RECORDS TO INDICATE THERE WAS A MANUFACTURING RELATED CAUSE FOR THIS EVENT. THIS IS THE ONLY COMPLAINT REPORTED TO DATE FOR THIS LOT NUMBER. THE STENTS REMAINED IMPLANTED AND THE DELIVERY SYSTEMS WERE DISCARDED BY USER FACILITY. THE EVENT INVESTIGATION IS CURRENTLY UNDERWAY. THIS EVENT IS BEING REPORTED BECAUSE THIS DEVICE IS THE SAME OR SIMILAR TO ONE MARKETED IN THE UNITED STATES 510(K) - K052132. THIS EVENT INVOLVES TWO DEVICES WITH THE SAME PRODUCT MALFUNCTION, SAME DEVICE INFORMATION AND USED IN THE SAME PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO STENTS PREMATURELY DETACHED FROM THE CATHETER. REPORTEDLY, THE PHYSICIAN ADVANCED THE CATHETER AND THE FIRST STENT DETACHED PREMATURELY, 5CM BEFORE REACHING THE INTENDED TREATMENT SITE. A SECOND STENT WAS DEPLOYED TO FIX THE DETACHED STENT AT THE SITE OF DEPLOYMENT. A THIRD STENT WAS ADVANCED TO TREAT THE LESION; HOWEVER, THIS STENT DETACHED 2 CM BEFORE REACHING THE TARGET LESION. THIS STENT WAS LEFT IN PLACE. THE TARGET LESION WAS NOT TREATED AND THE PROCEDURE WAS ABORTED. THERE WAS NO REPORT OF INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VALEO VASCULAR STENT VASCULAR STENT FGE BARD PERIPHERAL VASCULAR, INC. GFUE4220

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR