BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COIL-THERMO MECHANICAL

    MDR report key: 8958369 · Received September 3, 2019

    Report

    Report Number
    2954740-2019-00547
    Event Type
    Injury
    Date Received
    September 3, 2019
    Date of Event
    October 30, 2015
    Report Date
    August 12, 2019
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    KRD
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). CODMAN AND SHURTLEFF INC., DBA DEPUY SYNTHES PRODUCTS, INC. ((B)(4)). SINCE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE THE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER.  MISSING INFORMATION FROM THIS REPORT IS IDENTIFIED AS BLANK; THIS INFORMATION WAS NOT PROVIDED IN THE REPORTED EVENT OR AVAILABLE AT THE TIME OF REPORT SUBMISSION.

    Description of Event or Problem · 1

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. AS REPORTED IN THE LITERATURE PUBLICATION ENTITLED, ¿MEDINA EMBOLIZATION DEVICE FOR THE TREATMENT OF INTRACRANIAL ANEURYSMS: SAFETY AND ANGIOGRAPHIC EFFECTIVENESS AT 6 MONTHS¿. A (B)(6) YEAR-OLD MALE PATIENT WITH 13 WIDE-NECKED INTRACRANIAL ANEURYSM WHO UNDERWENT COIL EMBOLIZATION WITH MEDINA AND DELTAPLUSH COILS EXPERIENCED THROMBUS FORMATION AT LEFT A1-A2 JUNCTION, 1 DAY AFTER PROCEDURE. IV BOLUS OF ASPIRIN (250 MG) WAS GIVEN TO THE PATIENT AND THE ARTERIAL BLOOD PRESSURE WAS INCREASED BY THE ANESTHESIOLOGISTS. THESE MEDICATIONS LED TO CLOT LYSIS AND THE PATIENT PROGRESSIVELY RECOVERED FROM HIS NEUROLOGICAL DEFICIT. OBJECTIVE: TO EVALUATE THE FEASIBILITY, SAFETY, AND 6- TO 9-MO EFFECTIVENESS OF THIS NEW DEVICE FOR THE TREATMENT OF INTRACRANIAL WIDE-NECKED ANEURYSMS. METHODS: TWELVE PATIENTS (10 FEMALES, MEAN AGE=56 YR) WITH 13 WIDE-NECKED INTRACRANIAL ANEURYSMS (3 RUPTURED; 10 UNRUPTURED) WERE TREATED BY MEANS OF THE MED FROM JANUARY 2015 TO OCTOBER 2015. IN 15% OF THE CASES, MEDS WERE USED IN A STANDALONE FASHION; IN 85% OF THE CASES, ADDITIONAL REGULAR COILS WERE USED. ADJUNCTIVE COMPLIANT BALLOON WAS USED IN 4 OF 13 CASES (31%). PROCEDURE-RELATED COMPLICATIONS WERE SYSTEMATICALLY RECORDED; DISCHARGE AND 6- TO 9-MO FOLLOW-UP MODIFIED RANKIN SCALE WAS ASSESSED. ANGIOGRAPHIC FOLLOW-UP WAS PERFORMED WITH A MEAN DELAY OF 5.5 ± 1.7 MO. OCCLUSION RATE WAS EVALUATED IN POSTPROCEDURE AND AT MIDTERM FOLLOW-UP USING THE ROY¿RAYMOND SCALE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748886 COIL-THERMO MECHANICAL NEUROVASCULAR EMBOLIZATION DEVICE KRD MEDOS INTERNATIONAL SARL

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Life Threatening