BEUDAMED
    FDA Adverse Event Death Summary report: N

    GUGLIELMI DETACHABLE COIL (GDC)

    MDR report key: 2083437 · Received May 10, 2011

    Report

    Report Number
    2939204-2011-00255
    Event Type
    Death
    Date Received
    May 10, 2011
    Report Date
    April 19, 2011
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    HCG
    PMA / PMN Number
    K031049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: ANTICIPATED PROCEDURAL COMPLICATION. THE DEVICE HISTORY RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS UPON ITS RELEASE. THE DEVICE WAS NOT AVAILABLE FOR EVALUATION. FROM THE INFORMATION PROVIDED THERE IS NO INDICATION THAT THERE WAS ANY DEVICE MALFUNCTION, NONCONFORMANCE OR MISUSE THAT CONTRIBUTED TO THE REPORTED EVENT. DEATH AND THE ASSOCIATED COMPLICATIONS ARE KNOWN AND ANTICIPATED COMPLICATIONS TO THESE TYPES OF PROCEDURES AND IS LISTED AS SUCH IN THE DIRECTIONS FOR USE. THE PHYSICIAN ATTRIBUTES THE PATIENT'S DEATH TO THEIR PRESENTING CONDITION. THEREFORE IT WAS DETERMINED THAT THE REPORTED EVENT WAS AN ANTICIPATED PROCEDURAL COMPLICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT ENDOVASCULAR EMBOLIZATION OF AN ACUTELY RUPTURED ANTERIOR COMMUNICATING ARTERY (ACOM) ANEURYSM. UPON ATTEMPTED DEPLOYMENT OF APPROXIMATELY 2-3MM OF THE COIL, THERE WAS AN UNEXPECTED MOVEMENT OF THE MICROCATHETER TIP THAT RESULTED IN THE COIL PUSHING THROUGH THE DOME OF THE ANEURYSM CAUSING THE ANEURYSM TO RE-RUPTURE. AN ATTEMPT WAS MADE TO DEPLOY ADDITIONAL COILS WITHIN RUPTURED ANEURYSM, HOWEVER IMMEDIATE VASOSPASM AND AN ADJACENT HEMORRHAGE MASS AFFECT PROHIBITED MICROCATHETER AND COIL PLACEMENT. THE MICROCATHETER AND COIL WERE REMOVED AS ONE UNIT FROM THE PATIENT. 100MG OF PROTAMINE SULFATE AND 50MG OF MANNITOL WERE IMMEDIATELY ADMINISTERED INTRAVENOUSLY AND A RIGHT FRONTAL EXTERNAL VENTRICULAR DRAIN (EVD) WAS EMERGENTLY INSERTED. THE PATIENT LATER SUFFERED BRAIN HERNIATION AND SUBSEQUENT BRAIN DEATH.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT ENDOVASCULAR EMBOLIZATION OF AN ACUTELY RUPTURED ANTERIOR COMMUNICATING ARTERY (ACOM) ANEURYSM. UPON ATTEMPTED DEPLOYMENT OF APPROXIMATELY 2-3MM OF THE COIL, THERE WAS AN UNEXPECTED MOVEMENT OF THE MICROCATHETER TIP THAT RESULTED IN THE COIL PUSHING THROUGH THE DOME OF THE ANEURYSM CAUSING THE ANEURYSM TO RE-RUPTURE. AN ATTEMPT WAS MADE TO DEPLOY ADDITIONAL COILS WITHIN RUPTURED ANEURYSM, HOWEVER IMMEDIATE VASOSPASM AND AN ADJACENT HEMORRHAGE MASS AFFECT PROHIBITED MICROCATHETER AND COIL PLACEMENT. THE MICROCATHETER AND COIL WERE REMOVED AS ONE UNIT FROM THE PATIENT. 100MG OF PROTAMINE SULFATE AND 50MG OF MANNITOL WERE IMMEDIATELY ADMINISTERED INTRAVENOUSLY AND A RIGHT FRONTAL EXTERNAL VENTRICULAR DRAIN (EVD) WAS EMERGENTLY INSERTED. THE PATIENT LATER SUFFERED BRAIN HERNIATION AND SUBSEQUENT BRAIN DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUGLIELMI DETACHABLE COIL (GDC) DEVICE, NEUROVASCULAR EMBOLIZATION HCG BOSTON SCIENTIFIC - CORK M003341203SR40

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Death| R HEADLINER MICROGUIDEWIRE (MICROVENTION)| EXCELSIOR SL-10 MICROCATHETER (BOSTON SCIENTIFIC)| NEUROFORM 3 STENT SYSTEM (BOSTON SCIENTIFIC)