BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 5482695 · Received March 6, 2016

    Report

    Report Number
    1058196-2016-00023
    Event Type
    Death
    Date Received
    March 6, 2016
    Date of Event
    September 1, 2015
    Report Date
    February 8, 2016
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NEITHER THE CATALOGUE NUMBER NOR THE LOT NUMBER WAS AVAILABLE THUS NEITHER DHR NOR FAL COULD BE COMPLETED. DEATH IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE USE OF THE ENTERPRISE FAMILY OF DEVICES AND IS LISTED IN THE IFU AS SUCH. TO DATE NO CATALOGUE OR LOT NUMBER INFORMATION HAS BEEN AVAILABLE, HOWEVER, ALL PRODUCTS UNDERGO A 100% INSPECTION PRIOR TO BEING RELEASED FOR SALE; THERE IS NO EVIDENCE OF A MANUFACTURING ISSUE RELATED TO THIS COMPLAINT. REVIEW OF THE LIMITED INFORMATION SUGGESTS THAT MULTIPLE FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED PATIENT DEATH, SPECIFICALLY THE SIZE AND LOCATION OF THE TARGET ANEURYSM AND ANTI-COAGULATION MEDICATION REGIMEN. UDI: PART # UNKNOWN, LOT # NOT AVAILABLE, UDI NOT AVAILABLE.

    Description of Event or Problem · 1

    IN THE LITERATURE ARTICLE ¿INTRACRANIAL ANEURYSMS IN CHILDREN: THE ROLE OF STENTING AND FLOW-DIVERSION¿ BY SERGIO A. VARGAS, CARLOS DIAZ, DIEGO A. HERRERA, AND ARTHUR B. DUBLIN, PUBLISHED J NEUROIMAGING 2016;26:41-45. IT WAS REPORTED THAT 1 HOUR POST UNKNOWN ENTERPRISE STENT, THE PATIENT DIED. THIS WAS A (B)(6) MALE WHO PRESENTED WITH MASS EFFECT WITH CRANIAL NERVE PALSY. THE TARGET ANEURYSM WAS DESCRIBED AS 40MM FUSIFORM VERTEBROBASILAR OF IDIOPATHIC ORIGIN. TWO UNKNOWN ENTERPRISE STENTS WERE IMPLANTED WITH UNKNOWN EMBOLIC COILS. THE PATIENT RECOVERED FROM ANESTHESIA WITHOUT REPORTED EVENTS; HOWEVER, WAS PRESENTED WITH SUDDEN LOSS OF CONSCIOUSNESS AND BRAIN DEATH WAS CONFIRMED BY TRANSCRANIAL DOPPLER. THIS ARTICLE WAS PUBLISHED TO REPORT A SINGLE-CENTER EXPERIENCE IN THE ENDOVASCULAR MANAGEMENT OF CEREBRAL ANEURYSMS IN CHILDREN WITH STENTING AND FLOW-DIVERSION TECHNIQUES. DURING A 7-YEAR PERIOD, 5 MALE PATIENTS WITH SIX INTRACRANIAL ANEURYSMS (IA) WERE TREATED BY ENDOVASCULAR THERAPY WITH STENTING OR FLOW-DIVERSION. THE AVERAGE AGE WAS 11 YEARS (RANGE 6-18 YEARS). IN THIS SERIES, DEVICE-ASSISTED ENDOVASCULAR TECHNIQUES WERE A RELATIVELY SAFE AND EFFECTIVE METHOD OF TREATMENT OF PEDIATRIC ANEURYSMS. HOWEVER, CONTINUED FOLLOW-UP IS REQUIRED AFTER TREATMENT, BECAUSE THERE ARE UNSOLVED ISSUES REGARDING THE DURABILITY OF FLOW-DIVERTERS AND STENTS. ONE PATIENT DEATH OCCURRED AFTER TREATMENT OF A GIANT VERTEBROBASILAR ANEURYSM (STENTING AND EMBOLIZATION WITH HYDROCOILS). IN THIS CASE, THE PATIENT RECOVERED FROM THE ANESTHESIA WITHOUT FOCAL DEFICIT, BUT AFTER ONE HOUR PRESENTED SUDDEN LOSS OF CONSCIOUSNESS, AND BRAIN DEATH WAS CONFIRMED BY TRANSCRANIAL DOPPLER. NO DEVICE SPECIFIC INFORMATION, I.E. CATALOG/LOT NUMBER, IS AVAILABLE. THE CAUSE OF DEATH WAS NEVER CONFIRMED. THE PATIENT'S VESSELS WERE REPORTEDLY VERY TORTUOUS AND THE ANEURYSM WAS A GIANT ANEURYSM. NO CATALOG OR LOT NUMBERS FOR THE ENTERPRISE STENT ARE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138813 ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM CNV ENTERPRISE SES (NJE) NJE CODMAN AND SHURTLEFF, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Death| R