BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNCHRO .014GUIDE WIRE 300 CM LENGTH

    MDR report key: 5036607 · Received August 27, 2015

    Report

    Report Number
    3008853977-2015-00353
    Event Type
    Death
    Date Received
    August 27, 2015
    Date of Event
    May 8, 2015
    Report Date
    July 31, 2015
    Manufacturer
    STRYKER NEUROVASCULAR-UTAH
    Product Code
    DQX
    PMA / PMN Number
    K032146
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. 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. STROKE, VESSEL INJURY AND DEATH 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 WAS DISPOSED AT THE HOSPITAL.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT SUCCESSFUL STENT ASSISTED EMBOLIZATION OF THE POSTERIOR COMMUNICATION ARTERY ANEURYSM. THE SUBJECT GUIDEWIRE WAS USED DURING THE PROCEDURE. IMAGING SHOWED FULL ANEURYSM OCCLUSION. SIX HOURS LATER, THE PATIENT WAS NOTED TO HAVE LESS LEFT UPPER EXTREMITY STRENGTH AND THE LEFT NASOLABIAL GROOVE BECAME NARROW. IMAGING SHOWED THAT AN INFARCTION OCCURRED IN THE TREATED TERRITORY IN THE RIGHT INTERNAL CAROTID ARTERY. THE PATIENT WAS ADMINISTERED ANTIPLATELET, ANTICOAGULANT AND OTHER UNSPECIFIED TREATMENT TO IMPROVE THE BLOOD SUPPLY. HOWEVER, THE PATIENT'S CONDITION CONTINUED TO DETERIORATE. THE PATIENT DECIDED TO STOP TREATMENT AND LATER DIED AT HOME. THE EXACT DATE OF DEATH IS UNKNOWN. THE PHYSICIAN STATED THAT THE CAUSE OF THE STROKE WAS THE PARENT ARTERY STENOSIS AND THE PATIENT'S TORTUOUS ANATOMY. THE PHYSICIAN STATED THAT AN ACUTE IN-STENT THROMBOSIS INSIDE A NON-STRYKER STENT AND POSSIBLE VESSEL INJURY WITH DEVICES USED IN THE PROCEDURE MIGHT HAVE CONTRIBUTED TO THE REPORTED ADVERSE EVENT AS WELL.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT SUCCESSFUL STENT ASSISTED EMBOLIZATION OF THE POSTERIOR COMMUNICATION ARTERY ANEURYSM. THE SUBJECT GUIDEWIRE WAS USED DURING THE PROCEDURE. IMAGING SHOWED FULL ANEURYSM OCCLUSION. SIX HOURS LATER, THE PATIENT WAS NOTED TO HAVE LESS LEFT UPPER EXTREMITY STRENGTH AND THE LEFT NASOLABIAL GROOVE BECAME NARROW. IMAGING SHOWED THAT AN INFARCTION OCCURRED IN THE TREATED TERRITORY IN THE RIGHT INTERNAL CAROTID ARTERY. THE PATIENT WAS ADMINISTERED ANTIPLATELET, ANTICOAGULANT AND OTHER UNSPECIFIED TREATMENT TO IMPROVE THE BLOOD SUPPLY. HOWEVER, THE PATIENT铠CONDITION CONTINUED TO DETERIORATE. THE PATIENT DECIDED TO STOP TREATMENT AND LATER DIED AT HOME. THE EXACT DATE OF DEATH IS UNKNOWN. THE PHYSICIAN STATED THAT THE CAUSE OF THE STROKE WAS THE PARENT ARTERY STENOSIS AND THE PATIENT'S TORTUOUS ANATOMY. THE PHYSICIAN STATED THAT AN ACUTE IN-STENT THROMBOSIS INSIDE A NON-STRYKER STENT AND POSSIBLE VESSEL INJURY WITH DEVICES USED IN THE PROCEDURE MIGHT HAVE CONTRIBUTED TO THE REPORTED ADVERSE EVENT AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568429 SYNCHRO .014GUIDE WIRE 300 CM LENGTH WIRE, GUIDE, CATHETER DQX STRYKER NEUROVASCULAR-UTAH B35697

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death