BEUDAMED
    FDA Adverse Event Death Summary report: N

    WINGSPAN STENT

    MDR report key: 1890328 · Received November 3, 2010

    Report

    Report Number
    2939204-2010-01027
    Event Type
    Death
    Date Received
    November 3, 2010
    Date of Event
    June 20, 2010
    Report Date
    October 18, 2010
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT
    Product Code
    NJE
    PMA / PMN Number
    H050001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    HYDROCEPHALUS.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATION. THE SUBJECT DEVICE IS NOT AVAILABLE; THEREFORE, PHYSICAL ANALYSIS CANNOT BE PERFORMED. FROM THE INFORMATION AVAILABLE THERE IS NO INDICATION THAT THE PHYSICIAN DID NOT USE THE DEVICE ACCORDING TO THE DIRECTION FOR USE (DFU). THERE IS NO INDICATION FROM THE INFORMATION AVAILABLE THAT MISUSE CAUSED OR CONTRIBUTED TO THE EVENT. HEMORRHAGE AND PATIENT OUTCOME OF DEATH ARE KNOWN ANTICIPATED PROCEDURAL COMPLICATIONS ASSOCIATED WITH ENDOVASCULAR PROCEDURES AND NOTED AS SUCH IN THE DFU. THEREFORE, A ROOT CAUSE OF ANTICIPATED PROCEDURAL COMPLICATION HAS BEEN ASSIGNED TO THIS EVENT.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT SUCCESSFUL STENT ASSISTED ANGIOPLASTY OF THE M2 SEGMENT INFERIOR DIVISION OF THE RIGHT MIDDLE CEREBRAL ARTERY. IMMEDIATELY POST PROCEDURE, ANGIOGRAPHIC RUNS DID NOT DEMONSTRATE EVIDENCE OF ANY MAJOR DISTAL INTRACRANIAL VESSEL DROPOUT, CONTRAST EXTRAVASATION OR DISSECTION. THE PATIENT WOKE UP CLINICALLY STABLE IN THE RECOVERY ROOM. POST ADMISSION TO THE INTENSIVE CARE UNIT (ICU), THE PATIENT EXPERIENCED WORSENING DYSARTHRIA AND SUBSEQUENTLY BECAME UNRESPONSIVE. A CT SCAN REVEALED A LARGE RIGHT-SIDE INTRACRANIAL HEMORRHAGE WITH INTRACRANIAL EXTENSION. DUE TO HYDROCEPHALUS AN EMERGENT EXTERNAL VENTRICULAR DRAINAGE (EVD) WAS PLACED AND ELEVATED INTRACRANIAL PRESSURE PROMPTED HYPOTHERMIA. KEPPRA WAS ADMINISTERED (DOSE UNKNOWN) FOR SEIZURE, AND THE PATIENT WAS MAINTAINED ON PRESSOR SUPPORT (UNKNOWN DRUG TYPE AND DOZE ADMINISTERED). THE PATIENT'S CONDITION CONTINUED TO DECLINE, AND SIX DAYS POST THE INDEX PROCEDURE, THE FAMILY DECIDED TO WITHDRAW CARE. THE PATIENT EXPIRED EARLY MORNING THE SAME DAY. THE PHYSICIAN BELIEVES THAT THE INTRACRANIAL HEMORRHAGE WAS POSSIBLY DUE TO A REPERFUSION HEMORRHAGE. IN ADDITION, THE AUTOPSY REPORT IDENTIFIED THE PRIMARY CAUSE OF DEATH AS AN ACUTE RESPIRATORY DISTRESS SYNDROME (ARDS) VERSUS SEPTIC SHOCK ALONG WITH A SECONDARY CAUSE OF DEATH OF A SPONTANEOUS MASSIVE RIGHT INTRACRANIAL/INTRAVENTRICULAR HEMORRHAGE.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT SUCCESSFUL STENT ASSISTED ANGIOPLASTY OF THE M2 SEGMENT INFERIOR DIVISION OF THE RIGHT MIDDLE CEREBRAL ARTERY. IMMEDIATELY POST PROCEDURE, ANGIOGRAPHIC RUNS DID NOT DEMONSTRATE EVIDENCE OF ANY MAJOR DISTAL INTRACRANIAL VESSEL DROPOUT, CONTRAST EXTRAVASATION OR DISSECTION. THE PATIENT WOKE UP CLINICALLY STABLE IN THE RECOVERY ROOM. POST ADMISSION TO THE INTENSIVE CARE UNIT (ICU), THE PATIENT EXPERIENCED WORSENING DYSARTHRIA AND SUBSEQUENTLY BECAME UNRESPONSIVE. A CT SCAN REVEALED A LARGE RIGHT-SIDE INTRACRANIAL HEMORRHAGE WITH INTRACRANIAL EXTENSION. DUE TO HYDROCEPHALUS AN EMERGENT EXTERNAL VENTRICULAR DRAINAGE (EVD) WAS PLACED AND ELEVATED INTRACRANIAL PRESSURE PROMPTED HYPOTHERMIA. KEPPRA WAS ADMINISTERED (DOSE UNKNOWN) FOR SEIZURE, AND THE PATIENT WAS MAINTAINED ON PRESSOR SUPPORT (UNKNOWN DRUG TYPE AND DOSE ADMINISTERED). THE PATIENT'S CONDITION CONTINUED TO DECLINE, AND SIX DAYS POST THE INDEX PROCEDURE, THE FAMILY DECIDED TO WITHDRAW CARE. THE PATIENT EXPIRED EARLY MORNING THE SAME DAY. THE PHYSICIAN BELIEVES THAT THE INTRACRANIAL HEMORRHAGE WAS POSSIBLY DUE TO A REPERFUSION HEMORRHAGE. IN ADDITION, THE AUTOPSY REPORT IDENTIFIED THE PRIMARY CAUSE OF DEATH AS AN ACUTE RESPIRATORY DISTRESS SYNDROME (ARDS) VERSUS SEPTIC SHOCK ALONG WITH A SECONDARY CAUSE OF DEATH OF A SPONTANEOUS MASSIVE RIGHT INTRACRANIAL/INTRAVENTRICULAR HEMORRHAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WINGSPAN STENT STENT, INTRACRANIAL NEUROVASCULAR NJE BOSTON SCIENTIFIC - FREMONT M003WS0250150 12993502

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death| R GUIDEWIRE (UNKNOWN MANUFACTURER)| GATEWAY BALLOON CATHETER (BOSTON SCIENTIFIC)| HEPARIN 50 U| 8 FR ANGIOSEAL (UNKNOWN MANUFACTURER)| 5 FR DAV CATHETER (UNKNOWN MANUFACTURER)| 7 FR INTRODUCER SHEATH (UNKNOWN MANUFACTURER)| 6 FR NEURON GUIDECATHETER (PENUMBRA)| TRANSEND GUIDEWIRE (BOSTON SCIENTIFIC)