BEUDAMED
    FDA Adverse Event Death Summary report: N

    EXCELSIOR 1018 PRE-SHAPED 45 150CM

    MDR report key: 2883282 · Received December 21, 2012

    Report

    Report Number
    3008853977-2012-00022
    Event Type
    Death
    Date Received
    December 21, 2012
    Date of Event
    November 14, 2012
    Report Date
    December 3, 2012
    Manufacturer
    BOSTON SCIENTIFIC CORK, LTD
    Product Code
    DQY
    PMA / PMN Number
    K042568
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: PRODUCT LONG DESCRIPTION - CORRECTED. CATALOG # - CORRECTED. CONCLUSION: FOR ANTICIPATED PROCEDURAL COMPLICATION. THE DEVICE 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. DEATH, VESSEL PERFORATION AND HEMORRHAGE 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 PROCEDURAL COMPLICATION.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE TO THE MANUFACTURER.

    Description of Event or Problem · 1

    THE STENT WAS UNEVENTFULLY DEPLOYED ACROSS THE ANEURYSM NECK WITH ITS LEADING END ENTERING THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) M2 BRANCH, THE MIDDLE THIRD CROSSING THE ANEURYSM NECK AND THE TRAILING END IN THE DISTAL RIGHT MCA M1 BRANCH. FOLLOWING DEPLOYMENT OF THE STENT, A GUIDEWIRE TIP WAS EASILY ADVANCE THROUGH A STENT INTERSTICE WITHOUT DISTURBING THE POSITIONING OF THE STENT. HOWEVER, AS THE MICROCATHETER TIP (THE SUBJECT DEVICE) WAS BEING ADVANCED OVER THE GUIDEWIRE, THE TRAILING END OF THE STENT RETRACTED OUT OF THE RIGHT MCA M1 SEGMENT AND PROLAPSED INTO THE ANEURYSM. MULTIPLE ATTEMPTS WERE MADE WITH VARIOUS GUIDEWIRES TO MOVE THE ENTIRE STENT INTO THE ANEURYSM SAC WITHOUT SUCCESS. COIL EMBOLIZATION WAS PERFORMED AND PERI-PROCEDURE IMAGING DEMONSTRATED PRESERVATION OF RIGHT MCA ARTERIAL BRANCHES WITHOUT EVIDENCE OF CONTRAST EXTRAVASATION. THE PATIENT DID NOT WAKE UP FROM GENERAL ANESTHESIA. IMAGING DEMONSTRATED CONTRAST EXTRAVASATION CONSISTENT WITH SIGNIFICANT ACUTE SUBARACHNOID HEMORRHAGE AND SLIGHT RIGHT HEMISPHERIC SWELLING. THE PHYSICIAN STATED THAT THE HEMORRHAGE MAY HAVE RESULTED FROM EITHER RIGHT M3 BRANCH OR ANEURYSM PERFORATION. HEPARINIZATION WAS IMMEDIATELY REVERSED WITH PROTAMINE. SUBSEQUENTLY, THE PATIENT DEVELOPED SIGNIFICANT INTRACRANIAL HYPERTENSION WITH SIGNS OF BRAIN HERNIATION. AN EMERGENT LEFT FRONTAL EXTERNAL VENTRICULAR DRAINAGE (EVD) WAS PLACED TO TREAT INTRACRANIAL PRESSURE (ICP). HOWEVER, THE SEVERITY OF INTRACRANIAL HYPERTENSION RESULTED IN BRAIN DEATH. THE PATIENT DIED TWO DAYS POST PROCEDURE, THE CAUSE OF DEATH IS DEVELOPED SIGNIFICANT INTRACRANIAL HYPERTENSION WITH SIGNS OF BRAIN HERNIATION.

    Description of Event or Problem · 1

    THE STENT WAS UNEVENTFULLY DEPLOYED ACROSS THE ANEURYSM NECK WITH ITS LEADING END ENTERING THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) M2 BRANCH, THE MIDDLE THIRD CROSSING THE ANEURYSM NECK AND THE TRAILING END IN THE DISTAL RIGHT MCA M1 BRANCH. FOLLOWING DEPLOYMENT OF THE STENT, A GUIDEWIRE TIP WAS EASILY ADVANCE THROUGH A STENT INTERSTICE WITHOUT DISTURBING THE POSITIONING OF THE STENT. HOWEVER, AS THE MICROCATHETER TIP (THE SUBJECT DEVICE) WAS BEING ADVANCED OVER THE GUIDEWIRE, THE TRAILING END OF THE STENT RETRACTED OUT OF THE RIGHT MCA M1 SEGMENT AND PROLAPSED INTO THE ANEURYSM. MULTIPLE ATTEMPTS WERE MADE WITH VARIOUS GUIDEWIRES TO MOVE THE ENTIRE STENT INTO THE ANEURYSM SAC WITHOUT SUCCESS. COIL EMBOLIZATION WAS PERFORMED AND PERI-PROCEDURE IMAGING DEMONSTRATED PRESERVATION OF RIGHT MCA ARTERIAL BRANCHES WITHOUT EVIDENCE OF CONTRAST EXTRAVASATION. THE PATIENT DID NOT WAKE UP FROM GENERAL ANESTHESIA. IMAGING DEMONSTRATED CONTRAST EXTRAVASATION CONSISTENT WITH SIGNIFICANT ACUTE SUBARACHNOID HEMORRHAGE AND SLIGHT RIGHT HEMISPHERIC SWELLING. THE PHYSICIAN STATED THAT THE HEMORRHAGE MAY HAVE RESULTED FROM EITHER RIGHT M3 BRANCH OR ANEURYSM PERFORATION. HEPARINIZATION WAS IMMEDIATELY REVERSED WITH PROTAMINE. SUBSEQUENTLY, THE PATIENT DEVELOPED SIGNIFICANT INTRACRANIAL HYPERTENSION WITH SIGNS OF BRAIN HERNIATION. AN EMERGENT LEFT FRONTAL EXTERNAL VENTRICULAR DRAINAGE (EVD) WAS PLACED TO TREAT INTRACRANIAL PRESSURE (ICP). HOWEVER, THE SEVERITY OF INTRACRANIAL HYPERTENSION RESULTED IN BRAIN DEATH. THE PATIENT DIED TWO DAYS POST PROCEDURE, THE CAUSE OF DEATH IS DEVELOPED SIGNIFICANT INTRACRANIAL HYPERTENSION WITH SIGNS OF BRAIN HERNIATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXCELSIOR 1018 PRE-SHAPED 45 150CM CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC CORK, LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death NEUROFORM3 STENT SYSTEM (BOSTON SCIENTIFIC)