BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_NEUROVASCULAR_PRODUCT

    MDR report key: 3484714 · Received November 22, 2013

    Report

    Report Number
    3008853977-2013-00425
    Event Type
    Injury
    Date Received
    November 22, 2013
    Date of Event
    November 7, 2013
    Report Date
    November 8, 2013
    Manufacturer
    STRYKER NEUROVASCULAR CORK
    Product Code
    HCG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510(K)#: K050700; K031168 OR K012985. THE DEVICE IS NOT AVAILABLE TO THE MANUFACTURER.

    Additional Manufacturer Narrative · 1

    THE DEVICE 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. THROMBOSIS AND STROKE 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 PROCEDURAL COMPLICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING STENT ASSISTED EMBOLIZATION OF THE INTERNAL CAROTID ARTERY ANEURYSM (ICA), SIGNIFICANT RESISTANCE ENCOUNTERED AS THE PHYSICIAN WAS ATTEMPTING TO ADVANCE THE DEVICE TO THE TARGET LESION. THE COIL WAS STRETCHED AND REMOVED FROM THE PATIENT. IMAGING SHOWED A VESSEL THROMBOSIS OF THE MIDDLE CEREBRAL ARTERY (MCA) NEAR THE ICA. THE THROMBOSIS RESULTED IN A STROKE. THE PATIENT UNDERWENT SURGERY TO REMOVE THE BLOOD CLOT. PATENCY OF THE VESSEL WAS RESTORED AND THE EVENT WAS RESOLVED WITH NO RESIDUAL EFFECT. THE PATIENT IS IN STABLE CONDITION IN THE HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING STENT ASSISTED EMBOLIZATION OF THE INTERNAL CAROTID ARTERY ANEURYSM (ICA), SIGNIFICANT RESISTANCE ENCOUNTERED AS THE PHYSICIAN WAS ATTEMPTING TO ADVANCE THE DEVICE TO THE TARGET LESION. THE COIL WAS STRETCHED AND REMOVED FROM THE PATIENT. IMAGING SHOWED A VESSEL THROMBOSIS OF THE MIDDLE CEREBRAL ARTERY (MCA) NEAR THE ICA. THE THROMBOSIS RESULTED IN A STROKE. THE PATIENT UNDERWENT SURGERY TO REMOVE THE BLOOD CLOT. PATENCY OF THE VESSEL WAS RESTORED AND THE EVENT WAS RESOLVED WITH NO RESIDUAL EFFECT. THE PATIENT IS IN STABLE CONDITION IN THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608317 UNKNOWN_NEUROVASCULAR_PRODUCT DEVICE, NEUROVASCULAR EMBOLIZATION HCG STRYKER NEUROVASCULAR CORK

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention HEPARIN (DOSAGE UNKNOWN)| EXCELSIOR SL-10 MICROCATHETER (STRYKER)