BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTAPLUSH - CERECYTE MICROCOIL

    MDR report key: 6138892 · Received December 1, 2016

    Report

    Report Number
    2954740-2016-00294
    Event Type
    Malfunction
    Date Received
    December 1, 2016
    Date of Event
    September 27, 2016
    Report Date
    November 3, 2016
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    KRD
    PMA / PMN Number
    K083646
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COIL PROTRUSION INTO THE PARENT VESSEL AND INCOMPLETE EXPANSION ARE KNOWN POTENTIAL PRODUCT MALFUNCTIONS ASSOCIATED WITH THE USE OF THE CODMAN COILS AND STENT. ALTHOUGH THERE IS NO 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 TARGET LESION AND VESSEL ANATOMY AS WELL AS DEVICE INTERACTION MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. 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. PROTOCODE KRD/HCG.

    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. THE 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. 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
    790300 DELTAPLUSH - CERECYTE MICROCOIL NEUROVASCULAR EMBOLIZATION DEVICE KRD MEDOS INTERNATIONAL SARL NA

    Patients

    Seq Age Sex Outcome Treatment
    1