BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 3351340 · Received September 16, 2013

    Report

    Report Number
    1058196-2013-00253
    Event Type
    Death
    Date Received
    September 16, 2013
    Date of Event
    June 10, 2013
    Report Date
    August 23, 2013
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DUMONT ET AL, J NEUROINTERVENTION SURGERY, PUBLISHED ONLINE JULY 2, 2013, DOI: 10.1136/NEURINTSURG-2013-010794 FOR CASE 14 INDICATED THAT DURING THE PROCEDURE THE ENTERPRISE VRD (ENC452212/LOT UNK) WAS USED OFF LABELED AS A THROMBECTOMY DEVICE ON A PATIENT WITH A THROMBUS LOCATED IN RIGHT MCA, BUT THE DEVELOP SICH WITH WORSENING NIHSS SCORE FROM 12 AT PRESENTATION TO 25 AT 24 HOURS. THE PATIENT EXPIRED DUE TO RESPIRATORY FAILURE SECONDARY TO RIGHT MCA STROKE. THE TIMI AFTER REVASCULARIZATION WAS 2 AND THE MRS WAS 6 AFTER 1 MONTH. THE PATIENT RECEIVED INTRAVENOUS TPA PRIOR TO THE ATTEMPTED REVASCULARIZATION PROCEDURE, AND THE DILATION WAS CONDUCTED POST THROMBECTOMY. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, AND THE LOT NUMBER WAS NOT PROVIDED TO CONDUCT DHR REVIEW. AFTER REVASCULARIZATION THAT ALLEVIATES A HIGH-GRADE SYMPTOMATIC STENOTIC LESION, (HEMORRHAGE/CEREBRAL HYPERPERFUSION SYNDROME- USE TERM THAT WAS REPORTED) MAY OCCUR AS A RESULT OF A SUDDEN, RAPID INCREASE IN CEREBRAL BLOOD FLOW EXCESS OF THAT REQUIRED TO MEET METABOLIC DEMANDS. THERE ARE VARIOUS FACTORS IMPLICATED AS PLAYING A ROLE IN THIS, SUCH AS CEREBRAL AUTOREGULATION, HYPERTENSION, ISCHEMIA REPERFUSION INJURY, INTRAOPERATIVE ISCHEMIA, OXYGEN DERIVED FREE RADICALS AND BARORECEPTOR DYSFUNCTION. TRANSIENT CEREBRAL HYPEREMIA CAN LEAD TO SEVERE UNILATERAL HEADACHE, FACE AND EYE PAIN, CONFUSION, SEIZURES, FOCAL NEUROLOGIC DEFICITS, AND INTRACEREBRAL HEMORRHAGES. TYPICALLY, INTRACEREBRAL HEMORRHAGE DEVELOPS ON THE THIRD TO FIFTH POSTOPERATIVE DAY, THOUGH THERE HAVE BEEN CASES OBSERVED IMMEDIATELY AFTER SURGERY, AS WELL AS CASES DEVELOPED 3 WEEKS AFTER REVASCULARIZATION. ANTICOAGULATION IS A KNOWN RISK FACTOR FOR BRAIN HEMORRHAGE IN PATIENTS WITH PRE-EXISTING DISEASE. THE USE OF TPA ALSO PUTS THE PATIENT AT A HIGHER RISK FOR EXPERIENCE A HEMORRHAGIC STROKE.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS, AND ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    DUMONT ET AL, J NEUROINTERVENTION SURGERY, PUBLISHED ONLINE JULY 2, 2013, DOI: 10.1136/NEURINTSURG-2013-010794 FOR CASE 14 INDICATED THAT DURING THE PROCEDURE THE ENTERPRISE VRD (ENC452212/LOT UNK) WAS USED OFF LABELED AS A THROMBECTOMY DEVICE ON A PATIENT WITH A THROMBUS LOCATED IN RIGHT MCA, BUT THE DEVELOP SICH WITH WORSENING NIHSS SCORE FROM 12 AT PRESENTATION TO 25 AT 24 HOURS. THE PATIENT EXPIRED DUE TO RESPIRATORY FAILURE SECONDARY TO RIGHT MCA STROKE. THE TIMI AFTER REVASCULARIZATION WAS 2 AND THE MRS WAS 6 AFTER 1 MONTH. THE PATIENT RECEIVED INTRAVENOUS TPA PRIOR TO THE ATTEMPTED REVASCULARIZATION PROCEDURE, AND THE DILATION WAS CONDUCTED POST THROMBECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465144 ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM CNV ENTERPRISE SES (NJE) NJE CORDIS NEUROVASCULAR, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death