BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPIDER FX

    MDR report key: 5747682 · Received June 24, 2016

    Report

    Report Number
    2183870-2016-00445
    Event Type
    Injury
    Date Received
    June 24, 2016
    Report Date
    May 29, 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

    EVENT SOURCED THROUGH LITERATURE: NII, K., ET AL. (2015). "A MANUAL CAROTID COMPRESSION TECHNIQUE TO OVERCOME DIFFICULT FILTER PROTECTION DEVICE RETRIEVAL DURING CAROTID ARTERY STENTING." J STROKE CEREBROVASC DIS 24(1): 210-214.

    Description of Event or Problem · 1

    EVENT SOURCED THROUGH LITERATURE. PURPOSE OF STUDY WAS TO INVESTIGATE THE INCIDENCE OF EMBOLIC PROTECTION DEVICE RETRIEVAL DIFFICULTIES AT CAROTID ARTERY STENTING (CAS) WITH A CLOSED-CELL STENT AND TO DEMONSTRATE THE USEFULNESS OF A MANUAL CAROTID COMPRESSION ASSIST TECHNIQUE. BETWEEN JULY 2010 AND OCTOBER 2013, THE SITE PERFORMED 156 CAS PROCEDURES USING SELF-EXPANDABLE CLOSED-CELL STENTS. ALL PROCEDURES WERE PERFORMED WITH THE AID OF A FILTER DESIGN EMBOLIC PROTECTION DEVICE. THE EMBOLIC PROTECTION DEVICE WAS USUALLY RETRIEVED BY THE ACCESSORY RETRIEVAL SHEATH AFTER CAS. A MANUAL CAROTID COMPRESSION TECHNIQUE WAS APPLIED WHEN IT WAS DIFFICULT TO NAVIGATE THE RETRIEVAL SHEATH THROUGH THE DEPLOYED STENT. THERE WERE NO DIFFICULTIES EXPERIENCED RETRIEVING THE SPIDER FX DEVICE. CLINICAL OUTCOMES WERE COMPARED IN PATIENTS WHERE SIMPLE RETRIEVAL WAS POSSIBLE AND WITH PATIENTS WHERE THE MANUAL CAROTID COMPRESSION ASSISTED TECHNIQUE WAS USED FOR RETRIEVAL. NEUROLOGIC EVENTS WERE OBSERVED (TRANSIENT ISCHEMIC ATTACKS, MINOR STROKES AND 1 MAJOR STROKE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402665 SPIDER FX CATHETER, CAROTID, TEMPORARY, FOR EMBOLIZATION CAPTURE NTE COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization