BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 6406064 · Received March 15, 2017

    Report

    Report Number
    1226348-2017-00024
    Event Type
    Malfunction
    Date Received
    March 15, 2017
    Date of Event
    September 27, 2016
    Report Date
    February 22, 2017
    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

    THIS IS ONE OF ONE INITIAL/FINAL MDR REPORT BEING SUBMITTED FOR THIS COMPLAINT WITH ASSOCIATED MFR# 1226348-2017-00024. D4: UDI UNAVAILABLE; LOT UNKNOWN D11: 6F GUIDE CATHETER OR 8F GUIDING CATHETER, 6F INTERMEDIATE CATHETER; 0.021-INCH MICROCATHETER (PROWLER SELECT PLUS), 0.0165-INCH MICROCATHETER (EXCELSIOR SL10; STRYKER) H4: MANUFACTURING DATE UNAVAILABLE; LOT UNKNOWN H3, H6: BASED ON THE INFORMATION, THE EVENT COULD NOT BE CONFIRMED. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS AND A DEVICE HISTORY RECORD REVIEW CANNOT BE COMPLETED BECAUSE THE LOT FOR THE PRODUCT IS UNKNOWN. SINCE THE EVENT COULD NOT BE CONFIRMED AND THERE IS NO EVIDENCE OF A MANUFACTURING-RELATED MALFUNCTION, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    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.WOLF1, M. BENDSZUS, M. MÖHLENBRUCH, PUBLISHED CLINICAL RADIOLOGY, DOI 10.1007/S00062-016-0545-9, IT WAS REPORTED THAT TWO UNKNOWN ENTERPRISE 2 STENTS HAD INCOMPLETE EXPANSION. PER THE ARTICLE: ¿IN 11 CONSECUTIVE PATIENTS 12 ENTERPRISE 2 STENTS WERE USED TO TREAT 9 INTRACRANIAL ANEURYSMS AND 2 STENOSIS . ALL STENTS COULD EASILY BE DELIVERED INCLUDING PARTIAL OR COMPLETE RECAPTURING WHEN NECESSARY. IN TWO CASES (PATIENT 9) WITH SHARP ANGLED CURVES IN THE CAROTID SIPHON THERE WAS KINKING AND FLATTENING OF THE STENT RESULTING IN INCOMPLETE WALL APPOSITION OF THE STENT. MOREOVER, WHEN VASCULAR ANATOMY SHOWED CURVES WITH ANGLES >50° IT WAS REGULARLY OBSERVED THAT THE PROXIMAL STENT MARKERS WERE ASYMMETRICALLY ARRANGED ALONG THE VESSEL CIRCUMFERENCE WITHOUT INFLUENCE ON THE STENT APPOSITION. BOTH FINDINGS COULD BE REPRODUCED IN A SILICONE FLOW MODEL. CATHETERIZATION, STENT PLACEMENT AND DEPLOYMENT INCLUDING PARTIAL OR COMPLETE RESHEATHING WAS UNEVENTFUL IN ALL PROCEDURES. EMBOLIZATION WAS ACHIEVED BY ¿JAILING¿ THE MICROCATHETER. 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.¿PATIENT 9, A (B)(6) MALE PATIENT PRESENT WITH ANEURYSM IN SUPRA-OPTHALMIC INTERNAL CAROTID ARTERY. THE ENTERPRISE STENT DIMENSION WERE REPORTED TO BE LENGTH: 30 MM, DISTAL DIAMETER 4 MM AND PROXIMAL DIAMETER 5.8MM. THE ANGLE OF THE VESSEL CURVE WAS 180° AND THE RADIUS WAS 2.3 MM, 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.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
    188554 ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM INTRACRANIAL NEUROVASCULAR STENT NJE CODMAN AND SHURTLEFF, INC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR SEE H10