BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 3322749 · Received September 3, 2013

    Report

    Report Number
    1058196-2013-00232
    Event Type
    Death
    Date Received
    September 3, 2013
    Date of Event
    August 5, 2013
    Report Date
    August 6, 2013
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES: ENPOWER CONTROL CABLE (ECB00018200/LOT UNKNOWN); G2 COMPLEX XTRASOFT COIL 2.5X5 (641CX2505/LOT UNKNOWN); G2 COMPLEX XTRASOFT COIL 3X8 (641CX0308/LOT UNKNOWN); G2 TDL COMPLEX COIL 5X10 (641CF0510/LOT UNKNOWN); G2 TDL COMPLEX COIL 4X12 (641CF0412/ LOT UNKNOWN); G2 TDL COMPLEX COIL 4X8 (641CX0408/ LOT UNKNOWN); ENVOY (DETAILS UNKNOWN); SL 10 MICROCATHETER (DETAILS UNKNOWN); PROWLER SELECT PLUS MICROCATHETER (DETAILS UNKNOWN). THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS AND ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. (B)(4).

    Additional Manufacturer Narrative · 1

    THIS PATIENT WITH A HISTORY OF STAGE 4 THROAT AND NECK CANCER PRESENTED WITH A ¿BLOWN OUT¿ DISSECTING RIGHT CAROTID ARTERY PSEUDO ANEURYSM MEASURING 5MM WITH A 4.2MM NECK. AFTER SUCCESSFUL STENT ASSISTED COIL EMBOLIZATION USING AN ENTERPRISE VRD ((B)(4)/LOT UNKNOWN) AND CODMAN G2 COILS (B)(4) (ALL UNKNOWN LOTS) THE PATIENT WAS STABLE. HOWEVER, IT WAS REPORTED THAT LATER THE PATIENT¿S CAROTID ¿GAVE OUT¿/¿BLEW OUT¿ AGAIN. AN ATTEMPT WAS MADE TO CONTROL THE BLEEDING VIA EMBOLIZATION. THIS WAS UNSUCCESSFUL AND THE PATIENT EXSANGUINATED AND DIED. IT WAS REPORTED THAT THE DEVICES HAD NOTHING TO DO WITH THE PATIENT¿S DEATH BUT WERE USED PRIOR TO HIS DEATH; HOWEVER, THERE IS NO FURTHER INFORMATION REGARDING THE SITE OF THE BLEED AS RELATED TO THE DEVICES. DURING THE PROCEDURE THE RIGHT CAROTID WAS SELECTED WITH AN ENVOY WITH STENT PLACEMENT VIA A PROWLER SELECT PLUS AND COILING PERFORMED VIA A JAILED MICROCATHETER TECHNIQUE VIA AN SL 10 MICROCATHETER. THE LOT NUMBERS OF THE DEVICES ARE NOT KNOWN; THEREFORE A DEVICE HISTORY RECORD REVIEW CANNOT BE COMPLETED. THE CODMAN G2 COILS AND ENTERPRISE STENT REMAIN IMPLANTED. VESSEL RUPTURE AND HEMORRHAGE ARE KNOWN POSSIBLE ADVERSE EVENTS ASSOCIATED WITH THE USE OF THE GALAXY G2 AND ENTERPRISE VRD AS OUTLINED IN THE RESPECTIVE INSTRUCTIONS FOR USE. BASED ON THE AVAILABLE INFORMATION A DEFINITIVE RELATIONSHIP OF THE DEVICES TO THE EVENT CANNOT BE DETERMINED; HOWEVER, WITH REVIEW OF THE AVAILABLE INFORMATION THERE ARE NO IDENTIFIED DEVICE MANUFACTURING ISSUES AND IT WAS REPORTED THAT THE EVENT WAS NOT RELATED TO THE DEVICES. THIS PATIENT¿S SIGNIFICANT HISTORY OF STAGE 4 THROAT AND NECK CANCER AND PRE-EXISTING DISSECTION WITH RUPTURE PUT HIM AT HIGH RISK FOR REOCCURRENCE OF BLEEDING/CAROTID RUPTURE. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN. THIS IS 1 OF 6 REPORTS ASSOCIATED WITH (B)(4).

    Description of Event or Problem · 1

    THE PATIENT HAD A ¿BLOWN OUT¿ RIGHT CAROTID IN (B)(6). AFTER THE PROCEDURE, THE PATIENT EXSANGUINATED AND DIED. THE PATIENT HAD STAGE 4 THROAT AND NECK CANCER, AND WAS MADE HEMODYNAMICALLY STABLE AND BROUGHT TO (B)(6). THE ANGIOGRAM SHOWED A DISSECTED RIGHT CAROTID AND PSEUDO ANEURYSM THAT MEASURED 5MM WITH A 4.2MM NECK. THE DOCTOR DECIDED TO STENT AND COIL THE ANEURYSM. HE SELECTED THE RIGHT CAROTID WITH THE ENVOY, PLACED HIS SL 10 MICROCATHETER IN THE ANEURYSM, AND THEN INTRODUCED A PROWLER SELECT PLUS MICROCATHETER. HE THEN DEPLOYED THE ENTERPRISE STENT (ENF452212/LOT UNKNOWN) AND JAILED HIS SL 10 MICROCATHER. HE THEN DEPLOYED 5 CODMAN G2 COILS: G2 COMPLEX XTRASOFT COIL 2.5X5 (641CX2505/LOT UNKNOWN), G2 COMPLEX XTRASOFT COIL 3X8 (641CX0308/LOT UNKNOWN), G2 TDL COMPLEX COIL 5X10 (641CF0510/LOT UNKNOWN), G2 TDL COMPLEX COIL 4X12 (641CF0412/ LOT UNKNOWN), G2 TDL COMPLEX COIL 4X8 (641CX0408/ LOT UNKNOWN) AND SUCCESSFULLY COILED THIS ANEURYSM. AN ENPOWER CONTROL CABLE (ECB00018200/LOT UNKNOWN) WAS USED. THE PATIENT WAS STABLE POST STENT AND COIL DEPLOYMENT AND IT WAS A SUCCESSFUL CASE. LATER THE PATIENT¿S CAROTID GAVE OUT OR TO USE ANOTHER TERM ¿BLEW OUT¿ AGAIN, AND THE PATIENT BEGAN TO BLEED OUT. THE DOCTOR TRIED TO CONTROL THE BLEEDING THROUGH EMBOLIZATION TO NO AVAIL AND THE PATIENT EXSANGUINATED AND DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436183 ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM CNV ENTERPRISE SES (NJE) NJE CORDIS NEUROVASCULAR, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death