BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 5951448 · Received September 14, 2016

    Report

    Report Number
    1226348-2016-00138
    Event Type
    Death
    Date Received
    September 14, 2016
    Date of Event
    April 1, 2016
    Report Date
    August 17, 2016
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NEITHER THE PRODUCT NOR PRODUCT SPECIFIC INFORMATION WAS AVAILABLE, THUS NO DHR AND/OR PRODUCT ANALYSIS COULD BE PERFORMED. CEREBRAL HEMORRHAGE IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE USE OF THE ENTERPRISE VRD DEVICE AND IS LISTED AS SUCH IN THE PRODUCT IFU. ALTHOUGH THERE IS NOT PRODUCT SPECIFIC INFORMATION AVAILABLE, ALL PRODUCTS UNDERGO A 100% INSPECTION PRIOR TO BEING RELEASED FOR SALE; THERE IS NO EVIDENCE OF A MANUFACTURING ISSUE RELATED TO THIS COMPLAINT. THIS WAS AN OFF LABEL USE OF THE VRD DEVICE FOR TREATMENT OF A BASILAR ARTERY DISSECTION. REVIEW OF THE AVAILABLE INFORMATION SUGGESTS THAT THE PATIENT¿S DISEASE STATE, EXTENSIVE BASILAR ARTERY DISSECTION, ANTI-PLATELET MEDICATION REGIMEN AND NEUROLOGICAL STATE UPON ARRIVAL TO THE TREATING FACILITY ALL CONTRIBUTED TO THE EVENT OF FURTHER CEREBRAL HEMORRHAGE LEADING TO DEATH. NO FURTHER ACTION IS REQUIRED AT THIS TIME. UDI: PRODUCT # UNKNOWN, LOT # UNKNOWN, ATTEMPT TO FOLLOW UP FOR INFORMATION NOT SUCCESSFUL.

    Description of Event or Problem · 1

    IN THE LITERATURE ARTICLE ¿THREE CASES OF RUPTURED BASILAR ARTERY DISSECTION: FROM DIAGNOSIS TO ENDOVASCULAR TREATMENT¿ BY ANNE-LAURE DERELLE, CHARLOTTE BARBIER, ROMAIN TONNELET, LIANG LIAO, RENE´ ANXIONNAT, SERGE BRACARD, PUBLISHED WORLD NEUROSURG. (2016) 91:676.E1-676.E7. IT WAS REPORTED THAT A PATIENT HAD HEMORRHAGE 2 WEEKS AFTER A STENTING PROCEDURE. PER THE ARTICLE ¿CASE:1 - A (B)(6) YEAR-OLD MAN WAS ADMITTED IN A COMA AS A RESULT OF SEVERE SUBARACHNOID HEMORRHAGE(SAH) (WORLD FEDERATION OF NEUROSURGICAL SOCIETIES GRADING SYSTEM[WFNS] 5 AND GLASGOW COMA SCALE [GCS]SCORE 3) WITH TETRA VENTRICULAR FLOODING AND DILATION (FISHER GRADE 4).¿ THE PATIENT¿S DISEASE WAS VERY SEVERE AND WITH A RARE SHAPE (LONG BASILAR DISSECTION). COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) REVEALED AN ELONGATED IRREGULARITY IN THE UPPER HALF OF THE BASILAR ARTERY, SUGGESTING A RUPTURED DISSECTION. AN EXTERNAL VENTRICULAR SHUNT WAS INSERTED. THE DIAGNOSIS WAS CONFIRMED BY A DIAGNOSTIC ANGIOGRAPHY, WHICH FOUND A NARROWING AND DOUBLE LUMEN ASPECT INVOLVING A LONG SEGMENT OF THE UPPER BASILAR ARTERY. AFTER 3 DAYS IN THE INTENSIVE CARE UNIT (ICU), THE PATIENT¿S CLINICAL STATUS HAD SLIGHTLY IMPROVED, AND HIS CEREBRAL PRESSURE WAS GOOD. A BRAIN MAGNETIC RESONANCE IMAGING (MRI) DID NOT SHOW ANY MAJOR CEREBRAL DAMAGE, PARTICULARLY IN THE BRAIN STEM. WE DECIDED TO ATTEMPT AN ENDOVASCULAR TREATMENT. ANGIOGRAPHIC CONTROL SHOWED THE DISSECTION REMAINED STABLE THROUGHOUT THE PROCEDURE. THE ACTIVATED COAGULATION TIME (ACT) WAS MAINTAINED AT 2.5-3 TIMES THE BASELINE VALUE. WE CROSSED THE DISSECTION WITH A MICROCATHETER (RAPID TRANSIT[CODMAN, USA]) WITH A J-SHAPED MICRO WIRE (TRAXCESS 14 [MICROVENTION,USA]). BECAUSE WE DID NOT HAVE FLOW DIVERTERS AT OUR DISPOSAL, 3 OVERLAPPING STENTS (SELF-EXPANDING) WERE PLACED IN THE UPPER HALF OF THE BASILAR ARTERY (ENTERPRISE [CODMAN];4.5 X 22, 4.5 X 28, AND 4.5 X 14MM). THE PATIENT WAS ADMINISTERED 250 MG OF ASPIRIN DURING THE PROCEDURE, A HALF BOLUS OF ABCIXIMAB (5.65 ML) AFTER STENTING, AND A HALF LOADING DOSE OF CLOPIDOGREL (300MG) VIA THE NASOGASTRIC TUBE AFTER THE ANGIOGRAPHY. THERE WAS NO MORPHOLOGIC MODIFICATION OF THE ZONE OF DISSECTION AFTER PLACING THE STENTS ON ANGIOGRAPHY PERFORMED AT THE END OF THE PROCEDURE. THE PATIENT RECEIVED DAILY DUAL ANTIPLATELET MEDICATION OF ASPIRIN (75 MG) AND CLOPIDOGREL (75 MG). THE PATIENT¿S NEUROLOGIC STATUS FAILED TO IMPROVE. A CTA PERFORMED 2 WEEKS LATER SHOWED A NEW DILATION OF THE LATERAL WALL OF THE BASILAR ARTERY (FIG. 2A,B). HE WAS UNABLE TO UNDERGO A SCHEDULED ANGIOGRAPHY BECAUSE OF RESPIRATORY FAILURE, AND HE DIED A FEW DAYS LATER AFTER REBLEEDING (MODIFIED RANKIN SCALE [MRS] 6). THE AUTHOR STATED THAT THE REBLEED WAS THE CONSEQUENCE OF THE PATHOLOGY AND THERE WAS NO PROCEDURAL DIFFICULTY WITH THE 3 OVERLAPPING ENTERPRISE STENTS. AT THE TIME OF COMPLAINT ENTRY NO DEVICE SPECIFIC INFORMATION, I.E. CATALOGUE/LOT NUMBER, IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600363 ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM INTRACRANIAL NEUROVASCULAR STENT NJE CODMAN AND SHURTLEFF, INC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Death