BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COIL

    MDR report key: 6520717 · Received April 25, 2017

    Report

    Report Number
    2029214-2017-00548
    Event Type
    Injury
    Date Received
    April 25, 2017
    Report Date
    March 29, 2017
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    KRD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: HAILIN ZHANG, JIANSHENG ZHANG, JUN REN, ET AL. ENDOVASCULAR EMBOLIZATION OF THE RUPTURED INTRACRANIAL ANEURYSMS WITH DETACHABLE COILS (A REPORT OF 141 CASES) THE DEVICES WERE NOT RETURNED FOR ANALYSIS; THEREFORE, NO DEFINITIVE CONCLUSION CAN BE DRAWN REGARDING THE CLINICAL OBSERVATION. BASED ON THE REPORTED INFORMATION, THERE DID NOT APPEAR TO HAVE BEEN ANY DEFECT OF THE DEVICES DURING USE. THE EVENTS OCCURRED IN THE PATIENTS POST PROCEDURE AND THEIR CAUSES WERE UNKNOWN. THERE WERE LIMITED DEVICES AND PATIENTS INFORMATION AVAILABLE. PRODUCT CODE NEXUS COIL - HCG AXIUM COIL - KRD. MDRS RELATED TO SAME ARTICLE: 2029214-2017-00546 2029214-2017-00547 2029214-2017-00548 2029214-2017-00549.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THROUGH ARTICLE REVIEW THAT POST EMBOLIZATION COILING TREATMENT, 24 PATIENTS PRESENTED MILDLY DISABLED AND 7 PATIENTS PRESENTED SEVERELY DISABLED WHEN DISCHARGED. OF 141 ANEURYSMS, 100% OCCLUSION OCCURRED IN 93 CASES, 95% IN 31 CASES, 90% IN 10 CASES, <(><<)>90% IN 5 CASES AND UNSUCCESSFUL EMBOLIZATION OCCURRED IN 2 CASES. THE PATIENTS TREATED WITH NEXUS AND/OR AXIUM COILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301950 COIL DEVICE, EMBOLIZATION, VASCULAR KRD COVIDIEN (IRVINE) UNK NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability