BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COIL-HYDRAULIC

    MDR report key: 7860165 · Received September 10, 2018

    Report

    Report Number
    3008264254-2018-00536
    Event Type
    Malfunction
    Date Received
    September 10, 2018
    Date of Event
    December 31, 2017
    Report Date
    August 15, 2018
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    KRD
    PMA / PMN Number
    K093973
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION SUMMARY - 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. THEREFORE, NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME. AS A RESULT, WE ARE CLOSING THIS INVESTIGATION. IF THE COMPLAINT DEVICE IS RECEIVED IN THE FUTURE, WE WILL REOPEN THE COMPLAINT AND PERFORM THE INVESTIGATION AS APPROPRIATE. DEVICE HISTORY LOT - N/A. DEVICE HISTORY BATCH - N/A. DEVICE HISTORY REVIEW - N/A.

    Description of Event or Problem · 1

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. AS REPORTED IN THE LITERATURE PUBLICATION ENTITLED, ¿ENDOVASCULAR RETRIEVAL OF MIGRATED COIL WITHIN THE DISTAL MIDDLE CEREBRAL ARTERY USING STENTRIEVER DEVICE¿: A (B)(6) FEMALE PATIENT WITH A WIDE-NECKED MULTILOBULATED RIGHT ICA ANEURYSM AT THE COMMUNICATING SEGMENT, MEASURING 8 MM _ 5 MM, UNDERWENT BALLOON A BALLOON-ASSISTED COIL EMBOLIZATION OF A COMMUNICATING SEGMENT INTERNAL CAROTID ARTERY (ICA) ANEURYSM, COMPLICATED BY A COIL THAT DISPLACED FAR DISTALLY INTO THE M3 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA), WHICH WAS SUCCESSFULLY RETRIEVED USING A SOLITAIRE STENTRIEVER TITLE:¿ ENDOVASCULAR RETRIEVAL OF MIGRATED COIL WITHIN THE DISTAL MIDDLE CEREBRAL ARTERY USING STENTRIEVER DEVICE¿. (SOURCE:WORLD NEUROSURG. 2018 JUN 29. PII: S1878-8750(18)31391-3. DOI: 10.1016/J.WNEU.2018.06.175.) THE PURPOSE OF THIS STUDY WAS TO PRESENT A CASE OF A BALLOON-ASSISTED COIL EMBOLIZATION OF A COMMUNICATING SEGMENT INTERNAL CAROTID ARTERY ANEURYSM, COMPLICATED BY COIL MIGRATION FAR DISTALLY INTO THE MIDDLE CEREBRAL ARTERY, WHICH WAS RETRIEVED SUCCESSFULLY WITH A STENTRIEVER. METHOD: THE PATIENT¿S MEDICAL RECORDS WERE RETROSPECTIVELY REVIEWED, INCLUDING CLINICAL AND RADIOGRAPHIC INFORMATION. THIS STUDY RECEIVED INSTITUTIONAL REVIEW BOARD APPROVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701445 COIL-HYDRAULIC NEUROVASCULAR EMBOLIZATION DEVICE KRD CODMAN AND SHURTLEFF, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention