BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_NEUROVASCULAR_PRODUCT

    MDR report key: 3371895 · Received September 26, 2013

    Report

    Report Number
    3008853977-2013-00357
    Event Type
    Injury
    Date Received
    September 26, 2013
    Date of Event
    January 1, 2010
    Report Date
    September 23, 2013
    Manufacturer
    STRYKER NEUROVASCULAR CORK
    Product Code
    HCG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED AND WAS NOT AVAILABLE FOR ANALYSIS. FROM THE INFORMATION PROVIDED THERE WAS NO INDICATION THAT THE DEVICE WAS NOT USED AS IN ACCORDANCE WITH THE LABELING OR THAT THIS CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. HEADACHE AND DIZZINESS ARE KNOWN AND ANTICIPATED COMPLICATIONS TO THESE TYPES OF PROCEDURES AND ARE NOTED IN THE LABELING. THEREFORE, IT WAS DETERMINED THAT THE REPORTED EVENT WAS AN ANTICIPATED PATIENT COMPLICATION.

    Additional Manufacturer Narrative · 1

    PMA/510(K)# - K031049 / K042539. COMPLAINT SOURCE ¿ LITERATURE: YONG SAM SHIN ET AL. J KOREAN NEUROSURGICAL SOCIETY 54 : 19-24, 2013 - ATTACHMENT: [DR_KIM_THROMBOEMBOLIC_EVENTS_GDC_VS_TARGET_COILS_KNS-54-19_2013__[1].PDF]. THE DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED IN AN ARTICLE IN KOREAN NEUROSURGICAL SOCIETY THAT POST COIL EMBOLIZATION OF THE UNRUPTURED POSTERIOR INFERIOR CEREBELLAR ARTERY (PICA) ANEURYSM, THE PATIENT SUFFERED HEADACHE AND DIZZINESS. SEVERAL DIFFUSION-WEIGHTED IMAGING POSITIVE LESIONS (DWILS) WERE DETECTED IN IPSILATERAL PICA TERRITORY INDICATIVE OF A THROMBOEMBOLIC EVENT. THE SYMPTOMS IMPROVED COMPLETELY AT DISCHARGE. THE PATIENT UNDERWENT THE PROCEDURE BETWEEN JANUARY 2010 AND MARCH 2012. THE EXACT DATE OF THE PROCEDURE IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED IN AN ARTICLE IN KOREAN NEUROSURGICAL SOCIETY THAT POST COIL EMBOLIZATION OF THE UNRUPTURED POSTERIOR INFERIOR CEREBELLAR ARTERY (PICA) ANEURYSM, THE PATIENT SUFFERED HEADACHE AND DIZZINESS. SEVERAL DIFFUSION-WEIGHTED IMAGING POSITIVE LESIONS (DWILS) WERE DETECTED IN IPSILATERAL PICA TERRITORY INDICATIVE OF A THROMBOEMBOLIC EVENT. THE SYMPTOMS IMPROVED COMPLETELY AT DISCHARGE. THE PATIENT UNDERWENT THE PROCEDURE BETWEEN JANUARY 2010 AND MARCH 2012. THE EXACT DATE OF THE PROCEDURE IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487404 UNKNOWN_NEUROVASCULAR_PRODUCT DEVICE, NEUROVASCULAR EMBOLIZATION HCG STRYKER NEUROVASCULAR CORK

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other TWO GDC COILS (STRYKER)