BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TARGET 360 ULTRA 2MM X 3CM

    MDR report key: 3194962 · Received June 27, 2013

    Report

    Report Number
    3008853977-2013-00215
    Event Type
    Injury
    Date Received
    June 27, 2013
    Date of Event
    May 23, 2013
    Report Date
    June 6, 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

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. 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. ANEURYSM RUPTURE, HEMORRHAGE, STROKE AND HEADACHE 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

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    TWELVE HOURS POST STENT ASSISTED EMBOLIZATION OF THE LEFT ANTERIOR COMMUNICATING ARTERY ANEURYSM (ACOM), THE PATIENT HAD A HEADACHE AND A CT SCAN REVEALED A SUBARACHNOID HEMORRHAGE (SAH). THE SAH RESULTED IN A STROKE. TWO DAYS POST PROCEDURE, THE PATIENT RECOVERED AND THE HEADACHE DISAPPEARED. THERE WAS NO TREATMENT FOR THE REPORTED SAH AND STROKE. THE PHYSICIAN STATED THAT THE CAUSE OF THE SAH WAS AN ANEURYSM RUPTURE DUE TO¿BLOOD VESSEL PERFORATION BY COILS¿.

    Description of Event or Problem · 1

    AT 12 HOURS POST STENT ASSISTED EMBOLIZATION OF THE LEFT ANTERIOR COMMUNICATING ARTERY ANEURYSM (ACOM), THE PATIENT HAD A HEADACHE AND A CT SCAN REVEALED A SUBARACHNOID HEMORRHAGE (SAH). THE SAH RESULTED IN A STROKE. TWO DAYS POST PROCEDURE, THE PATIENT RECOVERED AND THE HEADACHE DISAPPEARED. THERE WAS NO TREATMENT FOR THE REPORTED SAH AND STROKE. THE PHYSICIAN STATED THAT THE CAUSE OF THE SAH WAS AN ANEURYSM RUPTURE DUE TO¿BLOOD VESSEL PERFORATION BY COILS.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294406 TARGET 360 ULTRA 2MM X 3CM DEVICE, NEUROVASCULAR EMBOLIZATION HCG STRYKER NEUROVASCULAR CORK 15373536

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other 7 TARGET COILS (STRYKER)| NEUROFORM3 EZ STENT (STRYKER)