BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 3680282 · Received March 14, 2014

    Report

    Report Number
    1058196-2014-00076
    Event Type
    Injury
    Date Received
    March 14, 2014
    Date of Event
    September 22, 2013
    Report Date
    February 21, 2014
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATALOG AND LOT NUMBER FOR THE DEVICE WAS NOT PROVIDED, THEREFORE, THE DEVICE UNK. ENTERPRISE ENC REPRESENTS AN ENTERPRISE VRD THAT THE CATALOG NUMBER BEGINS WITH ENC. THE PRODUCT REMAINS IMPLANTED, AND WILL NOT BE RETURNED FOR ANALYSIS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    AS REPORTED VIA A LITERATURE ARTICLE (GONZALEZ, ANA MARCOS, ET AL. ¿BLOOD BLISTER-LIKE ANEURYSMS: SINGLE CENTER EXPERIENCE AND SYSTEMATIC LITERATURE REVIEW¿ ,EUROPEAN JOURNAL OF RADIOLOGY, (2014): 197-205) A PATIENT (PATIENT #6) EXPERIENCED EMBOLIC LESIONS WITH CLOT FORMATION INSIDE THE STENT (ALSO REFERRED TO AS AN ISCHEMIC COMPLICATION) AFTER STENT ASSISTED COILING USING AN ENTERPRISE STENT (CATALOG AND LOT UNKNOWN) AND UNKNOWN COILS FOR TREATMENT OF LEFT INTERNAL CAROTID ARTERY BLOOD BLISTER-LIKE ANEURYSM WITH SUBARACHNOID HEMORRHAGE. THERE WERE TWO THROMBOEMBOLIC EVENTS REPORTED IN THE STUDY WITH ONE PATIENT HAVING STOPPED ANTI-PLATELET THERAPY FOR PLACEMENT OF A VENTRICULAR DRAIN AFTER ACCIDENTAL REMOVAL OF THE FIRST ONE. THE OTHER PATIENT HAD A POOR RESPONSE TO CLOPIDOGREL, AND HIS ANTIPLATELET REGIMEN WAS ADOPTED ACCORDING TO THE RESULTS OF PLATELET AGGREGATION INHIBITION TESTS. TREATMENT INCLUDED PLACEMENT OF AN ADDITIONAL STENT AND THE PATIENT RECOVERED COMPLETELY. ADDITIONAL INFORMATION PROVIDED INDICATED THAT ¿AS THE TEXT MENTIONS, IT IS A VERY COMPLEX TYPE OF ANEURYSM. THE ENTERPRISE STENT DID VERY WELL THE JOB AND WE HAD TO RETREAT THE PATIENT DUE TO A VASOSPASM AND WE DECIDED TO ADD MORE COILS TO THE ANEURYSM SAC. THE MEDICATION IS MARKED ON THE TEXT BELOW PLAVIX AND ASPIRIN. THE ANEURYSM HAD 3 X 3 X 3.4 MM AND THE VESSELS RANGED FROM 4 TO 4,2 MM. WE HAVE NO REFERENCES OF THE DEVICES USED AT THE TIME OF THE PROCEDURE. THE ENTERPRISE STENT DID VERY WELL THE JOB AND WE HAD TO RETREAT THE PATIENT DUE TO A VASOSPASM AND WE DECIDED TO ADD MORE COILS TO THE ANEURYSM SAC. THE MEDICATION IS MARKED ON THE TEXT BELOW PLAVIX AND ASPIRIN. THE ANEURYSM HAD 3 X 3 X 3.4 MM AND THE VESSELS RANGED FROM 4 TO 4,2 MM. THERE WERE NO REFERENCES OF THE DEVICES USED AT THAT TIME ((B)(6) 2008). THE ENTERPRISE VRD REMAINED IMPLANTED AND THE LOT NUMBER IS NOT KNOWN; THEREFORE, THE DEVICE HISTORY RECORD REVIEWS CANNOT BE COMPLETED. THROMBOSIS AND NEUROLOGIC CHANGES ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH STENT IMPLANTATION PROCEDURES AND ARE LISTED IN THE IFU AS SUCH. THE ACT OF STENT IMPLANTATION PRODUCES INTENDED DAMAGE TO THE INTIMA OF THE VESSEL WALL IN ORDER TO REMODEL THE WALL AND REESTABLISH PATENCY OF THE VESSEL. THE DISRUPTION OF THE INTIMAL LAYERS TRIGGERS THE IMMUNE SYSTEM TO HEAL THE DAMAGED AREAS, THUS ACTIVATING THE CLOTTING MECHANISM AS WELL AS THE INFLAMMATORY RESPONSE. THE COMBINATION OF INFLAMMATORY RESPONSE AND CLOTTING CASCADE CAN LEAD TO THROMBUS FORMATION IN SIDE OF THE STENT AROUND THE DAMAGED AREAS. THE PATIENT WAS NON-COMPLIANT WITH AN ANTIPLATELET REGIMEN JUST PRIOR TO THE THROMBOTIC EVENT. REVIEW OF THE LIMITED INFORMATION SUGGESTS THAT MEDICATION REGIMEN FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    AS REPORTED VIA A LITERATURE ARTICLE (GONZALEZ, ANA MARCOS, ET AL. ¿BLOOD BLISTER-LIKE ANEURYSMS: SINGLE CENTER EXPERIENCE AND SYSTEMATIC LITERATURE REVIEW¿, EUROPEAN JOURNAL OF RADIOLOGY, (2014): 197-205) A PATIENT (PATIENT #6) EXPERIENCED EMBOLIC LESIONS WITH CLOT FORMATION INSIDE THE STENT (ALSO REFERRED TO AS AN ISCHEMIC COMPLICATION) AFTER STENT ASSISTED COILING USING AN ENTERPRISE STENT (CATALOG AND LOT UNKNOWN) AND UNKNOWN COILS FOR TREATMENT OF LEFT INTERNAL CAROTID ARTERY BLOOD BLISTER-LIKE ANEURYSM WITH SUBARACHNOID HEMORRHAGE. THERE WERE TWO THROMBOEMBOLIC EVENTS REPORTED IN THE STUDY WITH ONE PATIENT HAVING STOPPED ANTI-PLATELET THERAPY FOR PLACEMENT OF A VENTRICULAR DRAIN AFTER ACCIDENTAL REMOVAL OF THE FIRST ONE. THE OTHER PATIENT HAD A POOR RESPONSE TO CLOPIDOGREL, AND HIS ANTIPLATELET REGIMEN WAS ADOPTED ACCORDING TO THE RESULTS OF PLATELET AGGREGATION INHIBITION TESTS. TREATMENT INCLUDED PLACEMENT OF AN ADDITIONAL STENT AND THE PATIENT RECOVERED COMPLETELY HISTORY: CHRONIC ALCOHOL USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153772 ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM CNV ENTERPRISE SES (NJE) NJE CORDIS NEUROVASCULAR, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention