BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 3681809 · Received March 16, 2014

    Report

    Report Number
    1058196-2014-00086
    Event Type
    Injury
    Date Received
    March 16, 2014
    Report Date
    February 21, 2014
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    CORRECTED EVENT DESCRIPTION. THE REPORTED EVENT WAS INSTANT STENOSIS.

    Additional Manufacturer Narrative · 1

    AS REPORTED VIA A LITERATURE ARTICLE (YOUNG DAE CHO, ET AL. ¿TIME-OF-FLIGHT MAGNETIC RESONANCE ANGIOGRAPHY FOR FOLLOW-UP OF COIL EMBOLIZATION WITH ENTERPRISE STENT FOR INTRACRANIAL ANEURYSM: USEFULNESS OF SOURCE IMAGES¿, KOREAN JOURNAL OF RADIOLOGY, (2014): 15:161-168) 5 PATIENTS EXPERIENCED INSTANT RESTENOSIS AFTER STENT ASSISTED COIL EMBOLIZATION WITH ENTERPRISE STENTS AND UNKNOWN COILS. THE RESTENOSES WERE GREATER THAN 33% AND WERE DISCOVERED GREATER THAN SIX MONTHS AFTER THE PROCEDURE. INFORMATION ABOUT SPECIFIC PATIENTS OR TREATMENT OF THE RESTENOSIS WAS NOT PROVIDED IN THE ARTICLE. NO ADDITIONAL INFORMATION WAS PROVIDED IN THE ARTICLE. THERE WAS NO RETURN OF COMPLAINT PRODUCT NOR IS THERE A KNOWN LOT NUMBER, THUS NO ANALYSIS OR DHR COULD BE PERFORMED. IN-STENT RESTENOSIS IS A WELL-KNOWN POTENTIAL COMPLICATION FOR THIS TYPE OF PROCEDURE AND IS LISTED IN THE IFU. IN THE LITERATURE, IN-STENT STENOSIS RATES RANGE FROM 11% TO 39% FROM 6 TO 12 MONTHS AFTER STENT PLACEMENT. RATES WERE HIGHER IN OLDER PATIENTS WITH MORE SEVERE ATHEROSCLEROSIS AND DEPENDED ON THE TYPE OF STENOSIS TREATED. IN-STENT STENOSIS WAS MORE PREVALENT IN OSTIAL STENT PLACEMENT PROCEDURES. STENOSES IN STENTS ARE USUALLY TREATED WITH INTRASTENT PTA OR PLACEMENT OF A SECOND STENT. PROGRESSION OF ATHEROSCLEROTIC DISEASE IS KNOWN TO CAUSE INSTANT RESTENOSIS AND DOES NOT INDICATE A DEVICE FAILURE. INTRA-ARTERIAL STENT PLACEMENT IS A TREATMENT OF THE DISEASE PROCESS AND IT NOT A PREVENTIVE OR CURE FOR THE PROGRESSION OF SYMPTOMS OF ATHEROSCLEROTIC ARTERY DISEASE. ALL PRODUCTS UNDERGO A 100% INSPECTION PRIOR TO RELEASE FOR MARKETING. THERE IS NO EVIDENCE OF MANUFACTURING ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT; THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. IT IS DIFFICULT TO ASSESS POTENTIAL CONTRIBUTING FACTORS WITH THE LIMITED INFORMATION AVAILABLE.

    Description of Event or Problem · 1

    AS REPORTED VIA A LITERATURE ARTICLE (YOUNG DAE CHO, ET AL. "TIME-OF-FLIGHT MAGNETIC RESONANCE ANGIOGRAPHY FOR FOLLOW-UP OF COIL EMBOLIZATION WITH ENTERPRISE STENT FOR INTRACRANIAL ANEURYSM: USEFULNESS OF SOURCE IMAGES", KOREAN JOURNAL OF RADIOLOGY, (2014): 15:161-168) 5 PATIENTS EXPERIENCED INSTANT STENOSIS AFTER STENT ASSISTED COIL EMBOLIZATION WITH ENTERPRISE STENTS AND UNKNOWN COILS. THE RESTENOSES WERE GREATER THAN 33% AND WERE DISCOVERED GREATER THAN SIX MONTHS AFTER THE PROCEDURE. INFORMATION ABOUT SPECIFIC PATIENTS OR TREATMENT OF THE RESTENOSIS WAS NOT PROVIDED IN THE ARTICLE. NO ADDITIONAL INFORMATION WAS PROVIDED IN THE ARTICLE.

    Description of Event or Problem · 1

    AS REPORTED VIA A LITERATURE ARTICLE (YOUNG DAE CHO, ET AL. ¿TIME-OF-FLIGHT MAGNETIC RESONANCE ANGIOGRAPHY FOR FOLLOW-UP OF COIL EMBOLIZATION WITH ENTERPRISE STENT FOR INTRACRANIAL ANEURYSM: USEFULNESS OF SOURCE IMAGES¿, KOREAN JOURNAL OF RADIOLOGY, (2014): 15:161-168) 5 PATIENTS EXPERIENCED INSTENT RESTENOSIS AFTER STENT ASSISTED COIL EMBOLIZATION WITH ENTERPRISE STENTS AND UNKNOWN COILS. THE RESTENOSES WERE GREATER THAN 33% AND WERE DISCOVERED GREATER THAN SIX MONTHS AFTER THE PROCEDURE. INFORMATION ABOUT SPECIFIC PATIENTS OR TREATMENT OF THE RESTENOSIS WAS NOT PROVIDED IN THE ARTICLE. NO ADDITIONAL INFORMATION WAS PROVIDED IN THE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156282 ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM CNV ENTERPRISE SES (NJE) NJE CORDIS NEUROVASCULAR, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other