BEUDAMED
    FDA Adverse Event Death Summary report: N

    NEUROFORM STENT

    MDR report key: 1913901 · Received December 3, 2010

    Report

    Report Number
    2939204-2010-01114
    Event Type
    Death
    Date Received
    December 3, 2010
    Date of Event
    November 3, 2010
    Report Date
    November 17, 2010
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT
    Product Code
    NJE
    PMA / PMN Number
    H020002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: ANTICIPATED PROCEDURAL COMPLICATION. THE DEVICE REMAINS IMPLANTED SO 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. INTRAPARENCHYMAL HEMORRHAGE AND THE PATIENT OUTCOME OF DEATH ARE KNOWN AND ANTICIPATED COMPLICATIONS TO THESE TYPES OF PROCEDURES AND ARE LISTED AS SUCH IN THE DIRECTIONS FOR USE. THEREFORE IT WAS DETERMINED THAT THE REPORTED EVENT WAS AN ANTICIPATED PROCEDURAL COMPLICATION.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION FROM THE USER FACILITY STATED THAT THE INTRAPARENCHYMAL HEMORRHAGE WAS NOT IN THE TERRITORY OF THE TREATED ANEURYSM, IT COULD BE RELATED TO THE STENT, GUIDEWIRES OR COIL USED IN THE PROCEDURE.

    Description of Event or Problem · 1

    A STENT WAS SUCCESSFULLY PLACED AT THE NECK OF THE LEFT SUPRACLINOID INTERNAL CAROTID ANEURYSM, THE PHYSICIAN ENCOUNTERED DIFFICULTIES DEPLOYING THE NON-BOSTON SCIENTIFIC COIL AND CHOOSE TO PERFORM A STAGED PROCEDURE. ANGIOGRAPHY DID NOT REVEALING ANY PERFORATION OR OTHER ANOMALIES. APPROXIMATELY TWO HOURS POST PROCEDURE, THE PATIENT SUFFERED A DELAYED INTRAPARENCHYMAL HEMORRHAGE AND SUBSEQUENTLY DIED THE SAME DAY. THE CAUSE OF THE HEMORRHAGE IS UNKNOWN.

    Description of Event or Problem · 1

    A STENT WAS SUCCESSFULLY PLACED AT THE NECK OF THE LEFT SUPRACLINOID INTERNAL CAROTID ANEURYSM, THE PHYSICIAN ENCOUNTERED DIFFICULTIES DEPLOYING THE NON-BOSTON SCIENTIFIC COIL AND CHOOSE TO PERFORM A STAGED PROCEDURE. ANGIOGRAPHY DID NOT REVEALING ANY PERFORATION OR OTHER ANOMALIES. APPROXIMATELY TWO HOURS POST PROCEDURE, THE PATIENT SUFFERED A DELAYED INTRAPARENCHYMAL HEMORRHAGE AND SUBSEQUENTLY DIED THE SAME DAY. THE CAUSE OF THE HEMORRHAGE IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEUROFORM STENT STENT, INTRACRANIAL NEUROVASCULAR NJE BOSTON SCIENTIFIC - FREMONT M003SNF340150

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| O TRANSEND GUIDEWIRE (BOSTON SCIENTIFIC)| SYNCHRO GUIDEWIRE (BOSTON SCIENTIFIC)| HEPARIN, DOSE UNKNOWN| CERECYTE COIL (MICRUS)