BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTEGE RX CAROTID STENT SYSTEM

    MDR report key: 7901359 · Received September 24, 2018

    Report

    Report Number
    2183870-2018-00448
    Event Type
    Injury
    Date Received
    September 24, 2018
    Date of Event
    March 29, 2017
    Report Date
    September 24, 2018
    Manufacturer
    COVIDIEN
    Product Code
    NIM
    PMA / PMN Number
    P060001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PREDICTION OF CEREBRAL HYPERPERFUSION AFTER CAROTID ARTERY STENTING BY CEREBRAL ANGIOGRAPHY AND SINGLE-PHOTON EMISSION COMPUTED TOMOGRAPHY WITHOUT ACETAZOLAMIDE CHALLENGE. TSUYOSHI OHTA, MD, PHD; ICHIRO NAKAHARA, MD, PHD; SHOJIMATSUMOTO, MD, PHD; RYOTA ISHIBASHI, MD; HARUKAMIYATA, MD; HIDEHISA NISHI, MD; S ADAYOSHIWATANABE, MD; IZUMI NAGATA,MD, PHD. NEUROSURGERY 81: 512¿519, 2017. HTTPS://DOI.ORG/10.1093/NEUROS/NYX041. AVERAGE AGE. MAJORITY GENDER. ESTIMATE BASED ON ARTICLE PUBLICATION DATE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE AUTHORS PERFORMED A RETROSPECTIVE STUDY OF PATIENTS UNDERGOING AN INITIAL CAROTID ARTERY STENTING (CAS) PROCEDURE FOR CAROTID ARTERY STENOSIS. IT WAS THEIR INTENT TO DEMONSTRATE THE UTILITY OF SINGLE PHOTON EMISSION COMPUTED TOMOGRAPHY (SPECT) IN CORRELATION WITH THE PATIENT¿S CEREBRAL ANGIOGRAM TO ASSESS THE RISK OF CEREBRAL HYPERPERFUSION SYNDROME. PATIENTS UNDERWENT STRICT REGULATION OF EACH DISEASE PRIOR TO TREATMENT. PATIENTS WERE PRESCRIBED 100 MG ASPIRIN AND 75 MG CLOPIDOGREL AT LEAST 3 DAYS PRIOR TO THE START OF TREATMENT. ALL TREATMENTS WERE PERFORMED UNDER SYSTEMIC HEPARINIZATION, WHICH WAS TITRATED TO AN ACTIVATED CLOTTING TIME OF 250 TO 350 S ONLY DURING THE PROCEDURE. UNDER DISTAL PROTECTION WITH A BALLOON OR FILTER WIRE, THE STENOSIS WAS PREDILATED WITH A 3.0 TO 3.5 MM BALLOON CATHETER AND A SELF-EXPANDING STENT DEPLOYED. THIRTY SEVEN CASES RECEIVED OPEN-CELL STENTS (OUT OF A TOTAL OF 100 CASES), WHICH CONSISTED OF 11 PROTEGE STENTS. THEIR FINDINGS WERE THAT PREOPERATIVE ASYMMETRY INDEX (AI) ON THE SPECT AND LEPTOMENINGEAL ANASTOMOSIS PREDICTED CEREBRAL HYPERPERFUSION PHENOMENON (CHP); AND CHP OCCURRED IN ALL CASE OF CEREBRAL HYPERPERFUSION SYNDROME. THE AUTHORS REPORTED 9 PATIENTS OF THE INCLUDED 100 PATIENTS WHO DEVELOPED CHP, AND 5 OF THEM HAD CEREBRAL HYPERPERFUSION SYNDROME. AS THE AUTHORS OF THE PRESENT ARTICLE POINT OUT, THIS MAY BE PREVENTED BY A MORE AGGRESSIVE REDUCTION IN BLOOD PRESSURE AT THE TIME OF REVASCULARIZATION. ANECDOTALLY, IT WOULD APPEAR MORE CASES OF CHP ARE ENCOUNTERED IN PATIENTS IN WHICH SIGNIFICANT DOSES OF ANTIHYPERTENSIVE AGENTS ARE REQUIRED TO ACHIEVE AN ACCEPTABLE BLOOD PRESSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744059 PROTEGE RX CAROTID STENT SYSTEM STENT, CAROTID NIM COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention