BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROFORM STENT

    MDR report key: 2063441 · Received April 19, 2011

    Report

    Report Number
    2939204-2011-00244
    Event Type
    Injury
    Date Received
    April 19, 2011
    Date of Event
    January 20, 2011
    Report Date
    March 31, 2011
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT
    Product Code
    NJE
    PMA / PMN Number
    H020002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT AVAILABLE FOR EVALUATION AS IT WAS IMPLANTED. FROM THE INFORMATION PROVIDED THERE IS NO INDICATION THAT THERE WAS ANY DEVICE MALFUNCTION, NONCONFORMANCE OR MISUSE THAT CONTRIBUTED TO THE REPORTED EVENT. VESSEL DISSECTION IS A KNOWN AND ANTICIPATED COMPLICATION 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 RECEIVED FROM THE USER FACILITY STATED THAT THE PHYSICIAN IS UNCERTAIN AS TO THE CAUSE OF THE DISSECTION AND THOUGHT IT MAY HAVE BEEN DUE TO THE DISTAL TIP OF THE GUIDEWIRE (MANUFACTURER UNKNOWN).

    Description of Event or Problem · 1

    FOUR HOURS POST SUCCESSFUL STENTING OF A BASILAR TIP ANEURYSM, IT WAS DISCOVERED THE PATIENT HAD SUFFERED A VESSEL DISSECTION IN THE DISTAL POSTERIOR CEREBRAL ARTERY (PCA) AFTER HAVING COMPLAINED OF HEADACHE. THE PATIENT RECOVERED AND IS REPORTED TO BE OKAY. NO FURTHER INFORMATION WAS REPORTED.

    Description of Event or Problem · 1

    FOUR HOURS POST SUCCESSFUL STENTING OF A BASILAR TIP ANEURYSM, IT WAS DISCOVERED THE PATIENT HAD SUFFERED A VESSEL DISSECTION IN THE DISTAL POSTERIOR CEREBRAL ARTERY (PCA) AFTER HAVING COMPLAINED OF HEADACHE. THE PATIENT RECOVERED AND IS REPORTED TO BE OKAY. NO FURTHER INFORMATION WAS REPORTED.

    Description of Event or Problem · 1

    FOUR HOURS POST SUCCESSFUL STENTING OF A BASILAR TIP ANEURYSM, IT WAS DISCOVERED THE PATIENT HAD SUFFERED A VESSEL DISSECTION IN THE DISTAL POSTERIOR CEREBRAL ARTERY (PCA) AFTER HAVING COMPLAINED OF HEADACHE. THE PATIENT RECOVERED AND IS REPORTED TO BE OKAY. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEUROFORM STENT STENT, INTRACRANIAL NEUROVASCULAR NJE BOSTON SCIENTIFIC - FREMONT UNK270

    Patients

    Seq Age Sex Outcome Treatment
    1 Other GUIDEWIRE (MANUFACTURER UNKNOWN)