BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPIDER FX

    MDR report key: 5935343 · Received September 8, 2016

    Report

    Report Number
    2183870-2016-00587
    Event Type
    Injury
    Date Received
    September 8, 2016
    Date of Event
    May 2, 2016
    Report Date
    August 9, 2016
    Manufacturer
    COVIDIEN
    Product Code
    NTE
    PMA / PMN Number
    K111010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    BACKGROUND THE USE OF DISTAL FILTER PROTECTION ALONE IS ASSOCIATED WITH A HIGH RISK OF ISCHEMIC COMPLICATIONS WHEN VULNERABLE CAROTID STENOSIS IS TREATED BY CAROTID ARTERY STENTING (CAS). DOUBLE BALLOON PROTECTION, A COMBINATION OF DISTAL BALLOON PROTECTION AND PROXIMAL BALLOON OCCLUSION, CAN BE UTILIZED. WE ASSESSED THE OUTCOME AND COMPLICATIONS OF THE DOUBLE BALLOON PROTECTION METHOD FOR VULNERABLE CAROTID STENOSIS. A DISTAL PROTECTION DEVICE SUCH AS A BALLOON (PERCUSURGE GUARD WIRE SYSTEM; (B)(4)) OR A FILTER [ANGIOGUARD XP ((B)(4)), FILTER WIRE EZ ((B)(4)), OR SPIDER FX ((B)(4))] WAS POSITIONED AT THE PROXIMAL SEGMENT TO THE PETROUS PORTION OF THE ICA IN ACCORDANCE WITH THE MANUFACTURER'S RECOMMENDATION. PREDILATION WAS PERFORMED USING A 3.0- TO 4.0-MM BALLOON CATHETER. A PRECISE STENT ((B)(4)), CAROTID WALLSTENT ((B)(4)), OR PROTEGE STENT SYSTEM ((B)(4)) WAS DEPLOYED, AND POSTDILATION WAS PERFORMED USING A 4.0- TO 5.0-MM BALLOON CATHETER 130 PATIENTS UNDERWENT CAROTID ARTERY STENTING (CAS). SIXTY-FOUR PATIENTS (71 %) UNDERWENT DOUBLE BALLOON PROTECTION, 15 PATIENTS (17 %) SIMPLE DISTAL BALLOON PROTECTION AND 11 PATIENTS (12 %) DISTAL FILTER PROTECTION. MAJOR ADVERSE CARDIAC AND CEREBROVASCULAR EVENTS WERE OBSERVED IN FOUR PATIENTS. NO PATIENTS EXPERIENCED PERMANENT SYMPTOMATIC COMPLICATIONS ASSOCIATED WITH ISCHEMIC INTOLERANCE INDUCED BY DOUBLE BALLOON PROTECTION, AND ONLY THREE PATIENTS (5 %) DEVELOPED MILD CONTRALATERAL HEMIPARESIS AND EXPERIENCED CONFUSION DURING DOUBLE BALLOON PROTECTION. ALL PATIENTS COMPLETELY RECOVERED IMMEDIATELY AFTER THE DEFLATION OF THE BALLOON

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    588970 SPIDER FX CATHETER, CAROTID, TEMPORARY, FOR EMBOLIZATION CAPTURE NTE COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other