BEUDAMED
    FDA Adverse Event Death Summary report: N

    NEUROFORM 3 EZ- 4.0 X 20MM

    MDR report key: 4750038 · Received May 5, 2015

    Report

    Report Number
    3008853977-2015-00205
    Event Type
    Death
    Date Received
    May 5, 2015
    Date of Event
    September 18, 2014
    Report Date
    April 28, 2015
    Manufacturer
    STRYKER NEUROVASCULAR CORK
    Product Code
    NJE
    PMA / PMN Number
    H020002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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. STROKE AND DEATH 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 PATIENT COMPLICATION.

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINED IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SUBJECT STENT AND A NON-STRYKER STENT WERE PLACED IN Y CONFIGURATION WITH FOLLOWING EMBOLIZATION WITH NON-STRYKER COILS TO TREAT AN UNRUPTURED BASILAR TIP ANEURYSM. THERE WAS NO EVIDENCE OF IMMEDIATE POST PROCEDURAL COMPLICATIONS. ONE MONTH FOLLOW-UP SHOWED THAT THE PATIENT WAS DOING WELL WITH NO COMPLAINTS. HOWEVER, TWO MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT SUFFERED A STROKE AND WAS BEING TREATED AN OUTSIDE FACILITY. MEDICAL THERAPY (NOT SPECIFIED) WAS PROVIDED. THE PHYSICIAN STATED THAT THE EVENT WAS NOT RELATED TO THE IMPLANTED STENT. ONE MONTH LATER, THE PATIENT DIED. THE CAUSE OF DEATH IS UNKNOWN. NO FURTHER DETAILS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SUBJECT STENT AND A NON-STRYKER STENT WERE PLACED IN Y CONFIGURATION WITH FOLLOWING EMBOLIZATION WITH NON-STRYKER COILS TO TREAT AN UNRUPTURED BASILAR TIP ANEURYSM. THERE WAS NO EVIDENCE OF IMMEDIATE POST PROCEDURAL COMPLICATIONS. ONE MONTH FOLLOW-UP SHOWED THAT THE PATIENT WAS DOING WELL WITH NO COMPLAINTS. HOWEVER, TWO MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT SUFFERED A STROKE AND WAS BEING TREATED AN OUTSIDE FACILITY. MEDICAL THERAPY (NOT SPECIFIED) WAS PROVIDED. THE PHYSICIAN STATED THAT THE EVENT WAS NOT RELATED TO THE IMPLANTED STENT. ONE MONTH LATER, THE PATIENT DIED. THE CAUSE OF DEATH IS UNKNOWN. NO FURTHER DETAILS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294766 NEUROFORM 3 EZ- 4.0 X 20MM STENT, INTRACRANIAL NEUROVASCULAR NJE STRYKER NEUROVASCULAR CORK 15630152

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death COILS ( MICROVENTION)| ENTERPRIZE STENT (CODMAN)