BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 6138872 · Received December 1, 2016

    Report

    Report Number
    1226348-2016-00178
    Event Type
    Malfunction
    Date Received
    December 1, 2016
    Date of Event
    September 27, 2016
    Report Date
    November 4, 2016
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO STERILE LOT NUMBER INFORMATION HAS BEEN AVAILABLE THUS NO DHR COULD BE PERFORMED. THE DEVICE WAS NOT AVAILABLE FOR ANALYSIS. INCOMPLETE EXPANSION IS A KNOWN POTENTIAL PRODUCT MALFUNCTION ASSOCIATED WITH THE USE OF THE CODMAN ENTERPRISE STENT. 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. REVIEW OF THE AVAILABLE INFORMATION SUGGESTS THAT VESSEL ANATOMY MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS. NO FURTHER ACTIONS ARE NEEDED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS NOT YET COMPLETE AND THE CONCLUSION IS NOT YET AVAILABLE. ADDITIONAL INFORMATION WILL BE PROVIDED WITHIN 30 DAYS. UDI: UNKNOWN PART NUMBER, ATTEMPTS TO OBTAIN LOT NUMBER HAVE NOT BEEN SUCCESSFUL, UDI UNAVAILABLE.

    Description of Event or Problem · 1

    IN THE LITERATURE ARTICLE ¿FIRST EXPERIENCES WITH THE NEW ENTERPRISE2 STENT¿ BY : C. HERWEH, S. NAGEL, J. PFAFF, C. ULFERT, M.WOLF, M. BENDSZUS, M. MÖHLENBRUCH . CLIN NEURORADIOL DOI 10.1007/S00062-016-0545-9. DATE OF PUBLICATION: 27-SEP 2016 THE AUTHORS REPORT THEIR EXPERIENCES WITH THE ENTERPRISE2 (EP2) STENT IN STENT-ASSISTED COILING AS WELL AS IN THE TREATMENT OF ATHEROSCLEROTIC STENOSIS. TWELVE (12) ENTERPRISE 2 STENTS WERE IMPLANTED IN 11 PATIENTS. PATIENT AGES RANGED BETWEEN 37 AND 64 YEARS. TWO PATIENTS WITH AN ATHEROSCLEROTIC STENOSIS WERE TREATED IN COMBINATION WITH PTA, ONE UNDER EMERGENCY CONDITIONS AFTER MECHANICAL THROMBECTOMY DUE TO ACUTE VERTEBRO-BASILAR ARTERIAL OCCLUSION. TARGET VESSELS WERE THE PETROUS INTERNAL CAROTID ARTERY (ICA) AND THE DISTAL VERTEBRAL ARTERY, RESPECTIVELY. STENT PLACEMENT WAS PERFORMED AFTER PTA IN BOTH CASES. NINE PATIENTS HAD STENT-ASSISTED COIL-EMBOLIZATION OF INTRACRANIAL ANEURYSMS, SEVEN OF WHICH WERE INCIDENTAL FINDINGS. ONE PATIENT HAD AN ACUTE SUBARACHNOID HEMORRHAGE (SAH) DUE TO A DISSECTING ANEURYSM OF THE BASILAR ARTERY AND ONE WAS TREATED DUE TO REPERFUSION OF A PREVIOUSLY RUPTURED AND COILED ANEURYSM. IN ONE PATIENT A SECOND STENT WAS PLACED WITHIN A FIRST ONE SITUATED IN THE SUPRAOPHTHALMIC ARTERY TO TREAT A PARTIAL COIL DISLOCATION IN A SEPARATE PROCEDURE. THE ANEURYSMS WERE LOCATED AT THE SUPRAOPHTHALMIC ICA IN FIVE PATIENTS, AT THE PROXIMAL ANTERIOR CEREBRAL ARTERY (A1¿A2 JUNCTION) IN TWO PATIENTS AND AT THE DISTAL ICA (POSTERIOR COMMUNICATING ARTERY ORIGIN) AND BASILAR ARTERY IN ONE PATIENT EACH. CATHETERIZATION, STENT PLACEMENT AND DEPLOYMENT INCLUDING PARTIAL OR COMPLETE RESHEATHING WAS UNEVENTFUL IN ALL PROCEDURES. THE STENT MARKERS WERE WELL-VISUALIZED BUT THE STRUT GEOMETRY COULD ONLY BE SEEN ON FPCT RECONSTRUCTION. THERE WAS CORRECT WALL APPOSITION IN ALL BUT TWO CASES (PATIENTS 9 AND 10). IN THESE TWO CASES, THE ANGLE OF THE VESSEL CURVE WAS 160° AND 180° AND THE RADIUS WAS 2.2 MM AND 2.3 MM, RESPECTIVELY. INCORRECT WALL APPOSITION LED TO THE KNOWN CRESCENT SHAPE WITH THE BENT STENT SITUATED CENTRALLY IN THE VESSEL LUMEN. IN PATIENT 9, FPCT AFTER 6 MONTHS REVEALED AN IDENTICAL CONFORMATION AND POSITION OF STENT AND COILS. IN ONE PATIENT A PREVIOUSLY INSERTED COIL (1.5 × 3 MM, DELTAPLUSH, CODMAN NEUROVASCULAR) WAS PARTIALLY DISLOCATED THROUGH THE STENT STRUTS AT THE OUTER CURVE INTO THE VESSEL LUMEN BY MANIPULATION WITH THE MICROCATHETER WHILE TRYING TO REACCESS THE ANEURYSM. THIS PROBLEM WAS SOLVED BY PLACING A SECOND EP2 (30 MM) WITHIN THE FIRST ONE (23 MM). NONE OF THE PATIENTS EXPERIENCED NEUROLOGICAL DETERIORATION AFTER THE PROCEDURE. NO MIGRATION OF ANY OF THE STENTS WAS OBSERVED AT DEPLOYMENT OR ON FOLLOW-UP. 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
    789102 ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM INTRACRANIAL NEUROVASCULAR STENT NJE CODMAN AND SHURTLEFF, INC NA

    Patients

    Seq Age Sex Outcome Treatment
    1