BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTEGE RX CAROTID STENT SYSTEM

    MDR report key: 12343553 · Received August 19, 2021

    Report

    Report Number
    2183870-2021-00302
    Event Type
    Injury
    Date Received
    August 19, 2021
    Date of Event
    January 19, 2021
    Report Date
    August 19, 2021
    Manufacturer
    COVIDIEN
    Product Code
    NIM
    PMA / PMN Number
    P060001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    JOURNAL TITLE: DIRECT ASPIRATION THROMBECTOMY EXPERIENCE WITH THE SOFIA 6F CATHETER IN ACUTE ISCHEMIC STROKE JAPANESE JOURNAL OF RADIOLOGY (2021) 39:605¿610. HTTPS://DOI.ORG/10.1007/S11604-021-01090-Z. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS SUBMITTED DETAILING A STUDY WHICH AIMED TO EVALUATE THE USEFULNESS OF A NON-MEDTRONIC (SOFIA) 6F CATHETER IN MECHANICAL THROMBECTOMY WITH THE DIRECT ASPIRATION FIRST PASS TECHNIQUE. 148 PATIENTS WERE INCLUDED IN THE STUDY. MEDTRONIC¿S SPIDER FX AND PROTÉGÉ RX DEVICES WERE USED IN THE STUDY. DURING PROCEDURES WITH TANDEM OCCLUSIONS (19 PATIENTS) THE STENOTIC SEGMENT WAS PASSED WITH A GUIDEWIRE, AND SPIDERFX EMBOLIC PROTECTION DEVICE WAS DEPLOYED IN THE TERMINAL SEGMENT OF THE CERVICAL ICA. SUBSEQUENTLY, EMERGENCY PERCUTANEOUS TRANSLUMINAL BALLOON ANGIOPLASTY USING A NON-MEDTRONIC BALLOON WAS PERFORMED FOR THE STENOTIC SEGMENT. IF BALLOON ANGIOPLASTY FAILED TO ACHIEVE LUMINAL PATENCY, THEN ADDITIONAL CAROTID STENTING WITH PROTEGE RX WAS PERFORMED TO ALLOW MECHANICAL THROMBECTOMY. A PROTÉGÉ RX STENT WAS PLACED IN 2 PATIENTS. AFTER ACHIEVING ADEQUATE LUMINAL PATENCY, THE NON-MEDTRONIC (SOFIA) 6F WAS NAVIGATED TO THE THROMBUS SITE, AND DIRECT ASPIRATION THROMBECTOMY WAS PERFORMED. ALL PATIENTS WERE FOLLOWED UP IN AN INPATIENT SETTING AND EVALUATED BY A MULTIDISCIPLINARY TEAM ON A REGULAR BASIS. THROMBOEMBOLIC COMPLICATIONS IN NEW TERRITORIES OCCURRED IN 8 CASES. AFTER TREATMENT, A SYMPTOMATIC INTRACRANIAL HEMORRHAGE (SICH) WAS OBSERVED IN 8 PATIENTS. IN THREE CASES, INTRACRANIAL DISSECTION WAS DETECTED AFTER THE USE OF THE STENT RETRIEVER. THE MORTALITY RATE AFTER THE PROCEDURE WAS 14.1%. THERE IS NO ESTABLISHED OR SUSPECTED CAUSAL RELATIONSHIP BETWEEN THE DEVICE(S) AND THE DEATH EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1240652 PROTEGE RX CAROTID STENT SYSTEM STENT, CAROTID NIM COVIDIEN UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR