BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPIDER FX

    MDR report key: 6043250 · Received October 20, 2016

    Report

    Report Number
    2183870-2016-00646
    Event Type
    Injury
    Date Received
    October 20, 2016
    Date of Event
    May 26, 2016
    Report Date
    September 21, 2016
    Manufacturer
    COVIDIEN
    Product Code
    NTE
    PMA / PMN Number
    K111010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT EVENT - AVERAGE AGE GENDER - GENDER - DATE OF EVENT - DATE OF PUBLICATION JAPAN RADIOLOGICAL SOCIETY 2016 JPN J RADIOL (2016) 34:523¿528 "PERIOPERATIVE AND FOLLOW-UP RESULTS IN CAROTID ARTERY STENTING WITH CONTRALATERAL CAROTID OCCLUSION" AHMET PEKER, MINE HAYRIYE SORGUN, CANAN TOGAY ISIKAY, ETHEM MURAT ARSAVA, MEHMET AKIF TOPCUOGLU, ANIL ARAT (B)(6). DOI 10.1007/S11604-016-0554-2. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ROUTINE PROCEDURE: OBTAINED ACCESS THROUGH THE PERCUTANEOUS FEMORAL ARTERY. CROSSED THE INTERNAL CAROTID ARTERY WITH THE EMBOLIC PROTECTION SYSTEM(TEN SPIDER FX DEVICES WERE USED DURING THE TREATMENT OF 26 PATIENTS.) DISTAL PROTECTION DEVICES WERE DEPLOYED BEYOND THE STENOSIS IN THE DISTAL SEGMENT OF THE NORMAL, STRAIGHT ICA. ANGIOPLASTY TYPICALLY PERFORMED TO PRE-DILATE THE LESION. A SELF-EXPANDING CLOSED-CELL STENT WAS THEN DEPLOYED. A SECOND STENT WAS DEPLOYED IF NEEDED. POST-DILATION WAS THEN PERFORMED WITH A BALLOON 20 MM IN LENGTH. IT IS REPORTED THAT 22 PATIENTS HAD A STROKE. CONTEXT OF STROKE UNKNOWN. ONE PATIENT WITH A POOR INITIAL NEUROLOGICAL STATUS HAS POST-PROCEDURE HYPERPERFUSION WITH SEIZURES BUT WITHOUT AN INTRACRANIAL BLEED. THE PATIENT WAS MANAGED MEDICALLY WITH INDUCED HYPOTENSION. CLOPIDOGREL WAS STOPPED AND THE PATIENT WAS DISCHARGED AT BASELINE NEUROLOGICAL STATUS AND PLACED ON ASPIRIN AND LOW MOLECULAR WEIGHT HEPARIN. THE PATIENT FAILED TO COMPLY WITH HIS MEDICATIONS AND PRESENTED WITH STENT OCCLUSION AFTER HIS DISCHARGE AND AFTER 30 DAYS. THERE WAS A DECLINE IN THE PATIENT'S MRS FROM 4 TO 5; OTHERWISE THERE WAS NO DECLINE IN MRS DURING THE POST-DISCHARGE FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695123 SPIDER FX CATHETER, CAROTID, TEMPORARY, FOR EMBOLIZATION CAPTURE NTE COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention