BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUARDWIRE TEMPORARY OCCLUSION SYSTEM

    MDR report key: 5936591 · Received September 8, 2016

    Report

    Report Number
    1220452-2016-00060
    Event Type
    Injury
    Date Received
    September 8, 2016
    Date of Event
    May 2, 2016
    Report Date
    August 9, 2016
    Manufacturer
    MEDTRONIC, INC
    Product Code
    DXE
    PMA / PMN Number
    K023878
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    "DOUBLE BALLOON PROTECTION DURING CAROTID ARTERY STENTING FOR VULNERABLE CAROTID STENOSIS REDUCES THE INCIDENCE OF NEW BRAIN LESIONS" ACTA BALLOON (2016) 158:1377¿1386 DOI 10.1007/S00701-016-2816-2.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    NINETY PATIENTS WHO UNDERWENT CAROTID ARTERY STENTING WERE ENROLLED IN A STUDY TO ASSESS THE OUTCOME AND COMPLICATIONS OF THE DOUBLE BALLOON PROTECTION METHOD FOR VULNERABLE CAROTID STENOSIS. GUARDWIRE DEVICES WERE USED IN BOTH CONVENTIONAL DISTAL PROTECTION PROCEDURES, AND DOUBLE BALLOON PROTECTION PROCEDURES. IT IS REPORTED THAT MINOR STROKE WAS EXPERIENCED BY 4 OF THE PATIENTS. THE PATIENTS RECOVERED. GUARDWIRE TEMPORARY OCCLUSION <(>&<)> ASPIRATION SYSTEM IS INDICATED FOR CAROTID USE IN (B)(6) BUT IS THE SAME AS THE GUARDWIRE TEMPORARY OCCLUSION <(>&<)> ASPIRATION SYSTEM APPROVED IN U.S WITH CORONARY INDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587735 GUARDWIRE TEMPORARY OCCLUSION SYSTEM CATHETER, EMBOLECTOMY DXE MEDTRONIC, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization