BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROFORM MICRODELIVERY STENT SYSTEM

    MDR report key: 1033818 · Received April 24, 2008

    Report

    Report Number
    2939204-2008-00143
    Event Type
    Injury
    Date Received
    April 24, 2008
    Date of Event
    March 26, 2008
    Report Date
    March 26, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NJE
    PMA / PMN Number
    H020002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE DIRECTIONS FOR USE (DFU) CONTAINS THE RISK OF THE REPORTED EVENT. PER THE DFU: "THE POTENTIAL ADVERSE EVENTS LISTED BELOW, AS WELL AS OTHERS, MAY BE ASSOCIATED WITH THE USE OF THE NEUROFORM MICRODELIVERY STENT SYSTEM OR WITH THE PROCEDURE...COIL HERNIATION THROUGH STENT INTO PARENT VESSEL...STENT MIGRATION.." AS WELL, THE DFU PRECAUTIONS USERS TO: "EXERCISE CAUTION WHEN CROSSING THE DEPLOYED STENT WITH ADJUNCT DEVICES."

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED IN 2008, REGARDING AN ANEURYSM COILING PROCEDURE OF THE INTERNAL CAROTID ARTERY (ICA): AS THIS WAS AN ELECTIVE PROCEDURE, THE PATIENT WAS ALERT, ORIENTED AND WELL PRIOR TO THE PROCEDURE. IN THE PROCEDURE, "....9 COILS PLACED TO THE SATISFACTION OF THE PHYSICIAN. UPON PLACING THE 10TH COIL, THE PHYSICIAN FELT THE POSITION WAS INCORRECT AND REQUIRED REPOSITIONING. WHEN REPOSITIONING THE COIL, THE PHYSICIAN LOST ONE TO ONE FEEL AND NOTED THAT IN HIS OPINION THE COIL WAS STRETCHING. ON TRYING TO WITHDRAW 10TH COIL, THE PREVIOUS COIL WAS DISLODGED FROM THE COIL BALL IN THE ANEURYSM SAC. THE TAIL OF THIS COIL BALL IN THE ANEURYSM SAC. THE TAIL OF THIS COIL WAS SEEN TO BE IN THE MIDDLE CEREBRAL ARTERY AND CAUSED VASOSPASM OF THE MIDDLE CEREBRAL ARTERY." THE 10TH COIL WAS REMOVED, AND IT WAS DECIDED THAT THE 9TH COIL NEEDED TO BE STABILIZED WITH A STENT (SUBJECT DEVICE). "THE STENT (SUBJECT DEVICE) WAS PLACED OVER THE NECK OF THE ANEURYSM AND HELPED APPOSE THE COIL TO THE VESSEL WALL WITHIN THE TERMINAL INTERNAL CAROTID ARTERY." ON WITHDRAWING THE GUIDEWIRE, "...THIS DISLODGED THE COIL FROM THE MIDDLE CEREBRAL ARTERY INTO THE INTERNAL CAROTID ARTERY LEAVING THE COIL INSIDE THE LUMEN OF THE STENT (SUBJECT DEVICE)." A SECOND STENT WAS THEN USED "...IN ATTEMPT TO JAIL THE COIL AGAINST THE VESSEL WALL. NUMEROUS ATTEMPTS WERE MADE TO CROSS THE FIRST STENT (SUBJECT DEVICE) AND COIL IN THE INTERNAL CAROTID ARTERY..." WITH TWO DIFFERENT GUIDEWIRES. ACCESS WAS EVENTUALLY GAINED WITH ONE OF THE GUIDEWIRES. A MICROCATHETER WAS ADVANCED OVER THE GUIDEWIRE. THE MICROCATHETER WAS WITHDRAWN, AND THE SECOND STENT DELIVERY SYSTEM WAS ADVANCED OVER THE GUIDEWIRE. "IT WAS UNABLE TO PASS THE FIRST STENT (SUBJECT DEVICE) DESPITE NUMEROUS ATTEMPTS..." THE PHYSICIAN DECIDED TO END THE PROCEDURE. ON TRYING TO REMOVE THE STENT DELIVERY SYSTEM AND GUIDEWIRE, THE FIRST STENT (SUBJECT DEVICE) AND LOOSE COIL WERE PULLED FROM THE TERMINAL INTERNAL CAROTID ARTERY INTO THE COMMON CAROTID ARTERY. "IT WAS DECIDED THAT A SNARE WAS TO BE USED TO TRY TO RETRIEVE THE COIL." THE COIL AND STENT (SUBJECT DEVICE) WERE RETRIEVED WITHOUT ISSUE. "THE PROCEDURE WAS FINISHED HERE WITH 8 COILS LEFT IN THE ANEURYSM." "IMMEDIATELY POST PROCEDURE, THE PATIENT WAS SEDATED AND VENTILATED AND TAKEN TO ICU [INTENSIVE CARE UNIT], WHERE SHE WAS KEPT UNDER OBSERVATION OVERNIGHT. SHE WAS EXTUBATED THE FOLLOWING DAY, AND SUFFERED NO LONG TERM EFFECTS AND WITH NO NEUROLOGICAL DEFICIT." THE PATIENT WAS DISCHARGED FROM THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEUROFORM MICRODELIVERY STENT SYSTEM NJE - STENT, INTRACRANIAL NEUROVASCULAR NJE BOSTON SCIENTIFIC E340020 0011319144

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention GDC-10 COIL| GDC-10 COIL| GDC-10 COIL| GDC-10 COIL| GDC-10 COIL| SYNCHRO GUIDEWIRE| EXCELSIOR SL-10 MICROCATHETER| NEUROFORM STENT| GDC-10 COIL| NEUROFORM STENT| SYNCHRO GUIDEWIRE| GDC-10 COIL| TRANSEND GUIDEWIRE| TRANSEND GUIDEWIRE| GDC-10 COIL| EXCELSIOR SL-10 MICROCATHETER| GDC-10 COIL