BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 5784191 · Received July 11, 2016

    Report

    Report Number
    1226348-2016-00121
    Event Type
    Injury
    Date Received
    July 11, 2016
    Date of Event
    January 2, 2014
    Report Date
    June 16, 2016
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS UNAVAILABLE FOR ANALYSIS AND NO STERILE LOT NUMBER WAS AVAILABLE THUS NO DHR COULD BE PERFORMED. THIS WAS AN OFF LABEL USE OF THE ENTERPRISE. THE IFU DOES NOT ADDRESS POTENTIAL HARMS TO THE PATIENT ASSOCIATED WITH OFF LABEL USE. THE DECISION TO USE A DEVICE IN AN OFF LABEL MANNER RESTS WITH THE CLINICIAN PERFORMING THE PROCEDURE. IN MANY CASES, WHERE OFF LABEL APPLICATIONS ARE USED, IT IS BECAUSE THERE ARE NO OTHER ALTERNATIVES AND THE CLINICIAN IS GIVING THE PATIENT THE BEST POSSIBLE OPTION IN A CRITICAL SITUATION. CEREBRAL INFARCT AND ARTERIAL DISSECTION ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE INDICATED USE OF THE ENTERPRISE DEVICE. 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. THERE IS NO NEED FOR FURTHER ACTION AT THIS TIME. REVIEW OF THE AVAILABLE INFORMATION SUGGESTS THAT TARGET LESION DISEASE PROCESS, INTRAPROCEDURAL ISSUES AND MEDICATION REGIMEN MAY HAVE ALL CONTRIBUTED TO THE REPORTED EVENT. UDI: PART # UNKNOWN, LOT # NOT AVAILABLE, UDI NOT AVAILABLE.

    Description of Event or Problem · 1

    IN THE LITERATURE ARTICLE ¿STENT ALONE TREATMENT FOR DISSECTIONS AND DISSECTING ANEURYSMS INVOLVING THE BASILAR ARTERY¿ BY CHUANHUI LI, YOUXIANG LI, CHUHAN JIANG, ZHONGXUE WU, YANG WANG, XINJIAN YANG , PUBLISHED J NEUROINTERVENT SURG 2015;7:50¿55. DOI:10.1136/NEURINTSURG-2013-010967, IT WAS REPORTED THAT IN OFF LABEL APPLICATION USAGE OF THE ENTERPRISE DEVICE, PATIENT #5 PRESENTED WITH A DISSECTION OF THE BASILAR ARTERY AND AFTER ENTERPRISE IMPLANTATION SUFFERED A PONTINE INFARCTION. THERE WERE NO DIFFICULTIES USING THE DEVICE AND THERE WERE NO PHYSICAL ANOMALIES FOUND ON THE DEVICE. PER THE ARTICLE: ¿BACKGROUND AND PURPOSE: DISSECTIONS AND DISSECTING ANEURYSMS INVOLVING THE BASILAR ARTERY (BA) ARE RARE LESIONS WITH A POOR PROGNOSIS, AND CONTROVERSIES EXIST ON TREATMENT STRATEGY. WE DESCRIBE THE CLINICAL PRESENTATION, RADIOLOGIC FEATURES, AND CLINICAL OUTCOMES OF 11 CONSECUTIVE PATIENTS WITH THESE LESIONS, TREATED USING STENT ALONE PLACEMENT¿.. CONCLUSIONS STENT ALONE TREATMENT AS A POTENTIAL AND DISPUTABLE ALTERNATIVE THERAPEUTIC OPTION FOR THE TREATMENT OF BA DISSECTION AND DISSECTING ANEURYSMS, ALTHOUGH TECHNICALLY FEASIBLE, WAS EFFECTIVE IN ONLY CERTAIN LESIONS, AND THIS TREATMENT CARRIES SUBSTANTIAL RISKS OF COMPLICATIONS AND A HIGH FAILURE RATE. THE TRUE EFFECT OF THIS STRATEGY IS QUESTIONABLE. A STUDY INVOLVING LARGER POPULATIONS AND A LONGER FOLLOW-UP IS NECESSARY TO EVALUATE THE EFFICACY OF THIS TREATMENT MODALITY.¿ THIS PATIENT PRESENTED WITH SUDDEN DIZZINESS AND VOMITING AND PREOPERATIVE IMAGING REVEALED INTRAMURAL THROMBUS AND FUSIFORM DILATION OF THE ENTIRE BASIL ARTERY WITH A NOTED DOUBLE LUMEN. TWO ENTERPRISE STENTS WERE IMPLANTED, 4.5 X 28MM. IT WAS REPORTED THAT THE PATIENT SUFFERED A PONTINE INFARCTION AS A COMPLICATION OF THE PROCEDURE. NO DEVICE SPECIFIC INFORMATION, I.E. LOT NUMBER, IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437525 ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM CNV ENTERPRISE SES (NJE) NJE CODMAN AND SHURTLEFF, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R