BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN_NEUROVASCULAR_PRODUCT

    MDR report key: 3878905 · Received June 17, 2014

    Report

    Report Number
    3008853977-2014-00189
    Event Type
    Death
    Date Received
    June 17, 2014
    Date of Event
    April 25, 2014
    Report Date
    May 21, 2014
    Manufacturer
    STRYKER NEUROVASCULAR CORK
    Product Code
    DQY
    PMA / PMN Number
    K042568
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 SUBJECT DEVICE IS NOT AVAILABLE; THEREFORE ANALYSIS CANNOT BE PERFORMED. FROM THE INFORMATION AVAILABLE, THERE IS NO INDICATION THAT THE REPORTED EVENT IS RELATED TO PRODUCT SPECIFICATIONS NONCONFORMANCE OR MISUSE. THERE IS ALSO NO INDICATION THAT THE SUBJECT DEVICE MALFUNCTIONED. HOWEVER, NEUROLOGICAL DEFICIT, ANEURYSM RUPTURE AND DEATH ARE KNOWN RISKS ASSOCIATED WITH SUCH PROCEDURES AND NOTED AS SUCH IN THE DIRECTIONS FOR USE (DFU). THEREFORE, A ROOT CAUSE OF ANTICIPATED PROCEDURAL COMPLICATION HAS BEEN ASSIGNED TO THE EVENT.

    Additional Manufacturer Narrative · 1

    SUBJECT DEVICE WAS DISPOSED.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT A COIL EMBOLIZATION PROCEDURE TO TREAT A VERTEBRAL ARTERY FENESTRATION ANEURYSM. AFTER THE FIRST (NON-STRYKER) COIL WAS DEPLOYED WITH THE MICROCATHETER, A STENT WAS DEPLOYED TO USE A ¿JAIL TECHNIQUE¿. IT WAS REPORTED THAT DURING STENT DEPLOYMENT, THE MICROCATHETER MOVED UNEXPECTEDLY AND ANGIOGRAPHY REVEALED EXTRAVASATION FROM THE ANEURYSM . THE PHYSICIAN ADMINISTERED PROTAMINE (EXACT DOSAGE UNKNOWN) AND IMPLANTED COILS TO STOP THE BLEEDING. ONE DAY POST PROCEDURE, THE PATIENT EXPERIENCED DISTURBANCES OF CONSCIOUSNESS. THREE DAYS POST PROCEDURE THE PATIENT DIED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT A COIL EMBOLIZATION PROCEDURE TO TREAT A VERTEBRAL ARTERY FENESTRATION ANEURYSM. AFTER THE FIRST (NON-STRYKER) COIL WAS DEPLOYED WITH THE MICROCATHETER, A STENT WAS DEPLOYED TO USE A ¿JAIL TECHNIQUE¿. IT WAS REPORTED THAT DURING STENT DEPLOYMENT, THE MICROCATHETER MOVED UNEXPECTEDLY AND ANGIOGRAPHY REVEALED EXTRAVASATION FROM THE ANEURYSM . THE PHYSICIAN ADMINISTERED PROTAMINE (EXACT DOSAGE UNKNOWN) AND IMPLANTED COILS TO STOP THE BLEEDING. ONE DAY POST PROCEDURE, THE PATIENT EXPERIENCED DISTURBANCES OF CONSCIOUSNESS. THREE DAYS POST PROCEDURE, THE PATIENT DIED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354652 UNKNOWN_NEUROVASCULAR_PRODUCT CATHETER, PERCUTANEOUS DQY STRYKER NEUROVASCULAR CORK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death PROTAMINE (EXACT DOSAGE UNKNOWN)| NEUROVASCULAR STENT (CODMAN)| COIL (MANUFACTURER UNKNOWN)