BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TARGET 360 SOFT 5 MM X 10 CM

    MDR report key: 3230248 · Received July 16, 2013

    Report

    Report Number
    3008853977-2013-00241
    Event Type
    Injury
    Date Received
    July 16, 2013
    Date of Event
    May 8, 2013
    Report Date
    June 24, 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 SUBJECT DEVICE IS NOT AVAILABLE; THEREFORE ANALYSIS CANNOT BE PERFORMED. FROM THE INFORMATION AVAILABLE, THERE IS NO INDICATION THAT THE REPORTED EVENT IS RELATED TO PRODUCT SPECIFICATIONS NONCONFORMANCE OR MISUSE. THERE IS ALSO NO INDICATION THAT THE SUBJECT DEVICE MALFUNCTIONED. HOWEVER, HEMORRHAGE IS A KNOWN RISK ASSOCIATED WITH SUCH PROCEDURES AND NOTED AS SUCH IN THE DIRECTIONS FOR USE (DFU). THEREFORE, A ROOT CAUSE OF ANTICIPATED PROCEDURAL COMPLICATION HAS BEEN ASSIGNED TO THE EVENT.

    Additional Manufacturer Narrative · 1

    SUBJECT DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A STENT WAS IMPLANTED IN THE PATIENT DURING EMBOLIZATION OF THE LEFT PARASELLAR REGION. SUBARACHNOID HEMORRHAGE OCCURRED DURING THE PROCEDURE NEAR THE PARACLINOID ANEURYSM. THE PATIENT ADMINISTERED PROTAMINE SULFATE (DOSAGE UNKNOWN) TO THE PATIENT AND INFLATED A HYPERGLIDE BALLOON (COVIDIEN) TO SHUT OFF BLOOD FLOW TO THE ANEURYSM UNTIL THE BLEEDING STOPPED. THE EVENT WAS RESOLVED WITH NO RESIDUAL EFFECT TO THE PATIENT. PER THE PHYSICIAN, IT IS NOT CLEAR WHAT CAUSED THE SAH, HOWEVER, THERE IS A POSSIBILITY THAT THE ANEURYSM WAS PERFORATED BY THE LAST COIL DURING EMBOLIZATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A STENT WAS IMPLANTED IN THE PATIENT DURING EMBOLIZATION OF THE LEFT PARASELLAR REGION. SUBARACHNOID HEMORRHAGE OCCURRED DURING THE PROCEDURE NEAR THE PARACLINOID ANEURYSM. THE PATIENT ADMINISTERED PROTAMINE SULFATE (DOSAGE UNKNOWN) TO THE PATIENT AND INFLATED A HYPERGLIDE BALLOON (COVIDIEN) TO SHUT OFF BLOOD FLOW TO THE ANEURYSM UNTIL THE BLEEDING STOPPED. THE EVENT WAS RESOLVED WITH NO RESIDUAL EFFECT TO THE PATIENT. PER THE PHYSICIAN, IT IS NOT CLEAR WHAT CAUSED THE SAH, HOWEVER, THERE IS A POSSIBILITY THAT THE ANEURYSM WAS PERFORATED BY THE LAST COIL DURING EMBOLIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328627 TARGET 360 SOFT 5 MM X 10 CM DEVICE NEUROVASCULAR EMBOLIZATION HCG STRYKER NEUROVASCULAR CORK 15726440R

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention NEUROFORM EZ STENT (STRYKER)| 9 TARGET COILS (STRYKER)