BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TARGET 360 ULTRA 2.5MM X 4CM

    MDR report key: 3133553 · Received May 29, 2013

    Report

    Report Number
    3008853977-2013-00166
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    March 11, 2013
    Report Date
    May 15, 2013
    Manufacturer
    STRYKER NEUROVASCULAR CORK
    Product Code
    HCG
    PMA / PMN Number
    K093142
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE SUBJECT DEVICE REMAINED IMPLANTED; THEREFORE, PHYSICAL ANALYSIS CANNOT BE PERFORMED. HOWEVER, PATIENT OUTCOME OF STROKE IS NOTED IN THE DIRECTION FOR USE (DFU). THEREFORE, A ROOT CAUSE OF ANTICIPATED PROCEDURAL COMPLICATIONS HAS BEEN ASSIGNED TO THIS EVENT.

    Additional Manufacturer Narrative · 1

    DEVICE IMPLANTED IN THE PATIENT'S BODY.

    Description of Event or Problem · 1

    DURING THE PROCEDURE A STENT AND 10 COILS WERE DEPLOYED IN THE ANEURYSM AT THE TIP OF THE BASILAR ARTERY. THE PATIENT EXPERIENCED AN ASYMPTOMATIC CEREBRAL INFARCTION AND MASS EFFECT. IN THE PHYSICIANS OPINION THE CEREBRAL INFARCTION WAS CAUSED BY THROMBOEMBOLISM. THE PHYSICIAN STATED THAT THE MASS EFFECT WAS DUE TO THE OCULOMOTOR NERVE WAS "COMPRESSED ON THE COIL MASS" (THE SUBJECT DEVICE) AND THE PATIENT SUFFERED DIPLOPIA AS A RESULT.

    Description of Event or Problem · 1

    DURING THE PROCEDURE, A STENT AND 10 COILS WERE DEPLOYED IN THE ANEURYSM AT THE TIP OF THE BASILAR ARTERY. THE PATIENT EXPERIENCED AN ASYMPTOMATIC CEREBRAL INFARCTION AND MASS EFFECT. IN THE PHYSICIANS OPINION THE CEREBRAL INFARCTION WAS CAUSED BY THROMBOEMBOLISM. THE PHYSICIAN STATED THAT THE MASS EFFECT WAS DUE TO THE OCULOMOTOR NERVE WAS "COMPRESSED ON THE COIL MASS" (THE SUBJECT DEVICE) AND THE PATIENT SUFFERED DIPLOPIA AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236866 TARGET 360 ULTRA 2.5MM X 4CM DEVICE NEUROVASCULAR EMBOLIZATION HCG STRYKER NEUROVASCULAR CORK 15390345

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other UNKNOWN COILS X 9| NEUROFORM EZ STENT (STRYKER)