BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXUS COIL

    MDR report key: 6909825 · Received October 3, 2017

    Report

    Report Number
    2029214-2017-01102
    Event Type
    Malfunction
    Date Received
    October 3, 2017
    Date of Event
    October 25, 2007
    Report Date
    October 2, 2017
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    HCG
    PMA / PMN Number
    K051425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    KANG, H., MOON, W., ROH, H. G., HAN, M. H., CHOE, W. J., CHO, J., . . . KOH, Y. C. (2007). MR ANGIOGRAPHIC EVALUATION IS LIMITED IN INTRACRANIAL ANEURYSMS EMBOLIZED WITH NEXUS COILS. NEURORADIOLOGY, 50(2), 171-178. DOI:10.1007/S00234-007-0320-3 THE NEXUS COILS WILL NOT BE RETURNED FOR EVALUATION AS THEY REMAINS IMPLANTED IN THE PATIENTS. THE DEVICES WERE NOT RETURNED, THEREFORE THE REPORTED EVENTS COULD NOT BE CONFIRMED. THE CAUSE OF THE EVENTS COULD NOT BE CONCLUSIVELY DETERMINED FROM THE REPORTED INFORMATION. MDRS RELATED TO THIS ARTICLE: 2029214-2017-01092 2029214-2017-01093 2029214-2017-01094 2029214-2017-01095 2029214-2017-01096 2029214-2017-01097 2029214-2017-01098 2029214-2017-01099 2029214-2017-01100 2029214-2017-01101 2029214-2017-01102 2029214-2017-01103 2029214-2017-01104 2029214-2017-01105 2029214-2017-01106 2029214-2017-01107 2029214-2017-01108 2029214-2017-01109. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC LITERATURE REVIEW FOUND A REPORT OF ARTIFACTS ON MAGNETIC RESONANCE ANGIOGRAPHY (MRA) AFTER NEXUS COILING OF CEREBRAL ANEURYSMS. THE PURPOSE OF THIS STUDY WAS TO REPORT 3D TIME OF FLIGHT (TOF) MRA FINDINGS IN PATIENTS TREATED WITH NEXUS COILS, WITH A FOCUS ON THE FEASIBILITY OF NONINVASIVE FOLLOW-UP. THE AUTHORS REVIEWED THE RECORDS OF 14 PATIENTS WITH 15 INTRACRANIAL ANEURYSMS WHO UNDERWENT COIL EMBOLIZATION USING A COMBINATION OF NEXUS COILS AND BARE PLATINUM COILS. THE AUTHORS REVIEWED POST-EMBOLIZATION 3D TOF MR ANGIOGRAMS AND RATED MRA ARTIFACTS AS: - GRADE 0: NO SIGNIFICANT SIGNAL LOSS - GRADE 1: PARTIAL SIGNAL LOSS OF THE PARENT ARTERY, BARELY MAINTAINING ITS CONTINUITY - GRADE 2: COMPLETE SEGMENTAL SIGNAL LOSS OF THE PARENT ARTERY PATIENT 1 (FEMALE, (B)(6)) UNDERWENT EMBOLIZATION OF A MIDDLE CEREBRAL ARTERY (MCA) ANEURYSM USING ONE NON-MEDTRONIC COIL AND ONE NEXUS (X-2-2-T10-HSS) COIL. THE ANEURYSM WAS COMPLETELY OCCLUDED. THE AUTHORS RATED THE ARTIFACTS ON TWO POST-EMBOLIZATION MRAS AS GRADE 1 AND GRADE 2. PATIENT 2 (FEMALE, (B)(6)) UNDERWENT EMBOLIZATION OF AN INTERNAL CAROTID ARTERY (ICA) ¿ POSTERIOR COMMUNICATING ARTERY (PCOA) ANEURYSM USING ONE NEXUS COIL (X-3-4-T10-TC) AND ONE NON-MEDTRONIC COIL. THE ANEURYSM WAS NEAR-COMPLETELY OCCLUDED. THE AUTHORS RATED THE ARTIFACTS ON TWO POST-EMBOLIZATION MRAS AS GRADE 1 AND GRADE 2. PATIENT 3 (MALE, (B)(6)) UNDERWENT EMBOLIZATION OF AN ICA-PCOA ANEURYSM USING THREE NEXUS COILS (X-5-10-T10-TC, X-2-3-T10-HSS, X-2 -3-T10-HSS) AND ONE NON-MEDTRONIC COIL. THE ANEURYSM WAS COMPLETELY OCCLUDED. THE AUTHORS RATED THE ARTIFACTS ON A POST-EMBOLIZATION MRA AS GRADE 2. PATIENT 4 (MALE, (B)(6)) UNDERWENT EMBOLIZATION OF AN ICA-PCOA ANEURYSM USING THREE NON-MEDTRONIC COILS AND ONE NEXUS COIL (X-2-2- T10-HSS). THE ANEURYSM WAS COMPLETELY OCCLUDED. POST-EMBOLIZATION MRA SHOWED GRADE 1 ARTIFACTS. THE AUTHORS RATED THE ARTIFACTS ON A POST-EMBOLIZATION MRA AS GRADE 1. THE PATIENT UNDERWENT EMBOLIZATION OF A SECOND ANEURYSM IN THE MCA USING TWO NON-MEDTRONIC COILS AND ONE NEXUS COIL (X-2-1-T10-HSS). THE ANEURYSM WAS NEAR-COMPLETELY OCCLUDED. THE AUTHORS RATED THE ARTIFACTS ON A POST-EMBOLIZATION MRA AS GRADE 2. PATIENT 5 (MALE, (B)(6)) UNDERWENT EMBOLIZATION OF AN ANTERIOR COMMUNICATING ARTERY (ACOA) ANEURYSM USING ONE NEXUS COIL (X-3-4-T10-TC) AND TWO NON-MEDTRONIC COILS. THE ANEURYSM WAS NEAR-COMPLETELY OCCLUDED. THE AUTHORS RATED THE ARTIFACTS ON A POST-EMBOLIZATION MRA AS GRADE 2. PATIENT 6 (MALE,(B)(6)) UNDERWENT EMBOLIZATION OF AN ACOA ANEURYSM USING TWO NON-MEDTRONIC COILS AND TWO NEXUS COILS (X-3-8-T10-MC, X-2-4-T10-HSS). THE ANEURYSM WAS COMPLETELY OCCLUDED. THE AUTHORS RATED THE ARTIFACTS ON A POST-EMBOLIZATION MRA AS GRADE 1. PATIENT 7 (MALE, (B)(6)) UNDERWENT EMBOLIZATION OF AN ACOA ANEURYSM USING THREE NEXUS COILS (X-6-12-T10-MC, X-6-12-T10-MC, X-5-15-T10-MC) AND THREE NON-MEDTRONIC COILS. THE ANEURYSM WAS NEAR-COMPLETELY OCCLUDED. THE AUTHORS RATED THE ARTIFACTS ON A POST-EMBOLIZATION MRA AS GRADE 2. PATIENT 8 (FEMALE, 71 YEARS) UNDERWENT EMBOLIZATION OF AN ICA-PCOA ANEURYSM USING THREE NEXUS COILS (X-4-10-T10-MC, X-3-8-T10-MC, X- 2-8-T10-HSS) AND ONE NON-MEDTRONIC COIL. THE ANEURYSM WAS NEAR-COMPLETELY OCCLUDED. THE AUTHORS RATED THE ARTIFACTS ON A POST-EMBOLIZATION MRA AS GRADE 2. PATIENT 9 (FEMALE, (B)(6)) UNDERWENT EMBOLIZATION OF AN ICA-PCOA ANEURYSM USING FIVE NEXUS COILS (X-3-5-T10-MC, X-3-5-T10-MC, X-2- 4-T10-HSS, X-2-2-T10-HSS, X-2-2-T10-HSS) AND TWO NON-MEDTRONIC COILS. THE ANEURYSM WAS NEAR-COMPLETELY OCCLUDED. THE AUTHORS RATED THE ARTIFACTS ON A POST-EMBOLIZATION MRA AS GRADE 2. PATIENT 10 (MALE, (B)(6)) UNDERWENT EMBOLIZATION OF AN ICA-A1 ANTERIOR CEREBRAL ARTERY (ACA) USING TWO NEXUS COILS (UNKNOWN MODEL, X-3-8-T10-MC) AND ONE NON-MEDTRONIC COIL. THE ANEURYSM WAS NEAR-COMPLETELY OCCLUDED. THE AUTHORS RATED THE ARTIFACTS ON A POST-EMBOLIZATION MRA AS GRADE 2. PATIENT 11 (MALE, (B)(6)) UNDERWENT EMBOLIZATION OF AN ACOA ANEURYSM USING THREE NEXUS COILS (X-5-10-T10-MC, X-3-8-T10-MC, X-2-6-T10-HSS) AND TWO NON-MEDTRONIC COILS. THE ANEURYSM WAS NEAR-COMPLETELY OCCLUDED. THE AUTHORS RATED THE ARTIFACTS ON A POST-EMBOLIZATION MRA AS GRADE 2. PATIENT 12 (FEMALE, (B)(6)) UNDERWENT EMBOLIZATION OF AN MCA ANEURYSM USING ONE NEXUS COIL (X-4-10-T10-MC) AND FOUR NON-MEDTRONIC COILS. THE ANEURYSM WAS COMPLETELY OCCLUDED. THE AUTHORS RATED THE ARTIFACTS ON A POST-EMBOLIZATION MRA AS GRADE 2. PATIENT 13 (FEMALE, (B)(6)) UNDERWENT EMBOLIZATION OF AN ICA-PCOA ANEURYSM USING TWO NEXUS COILS (X-5-10-T10-TC, X-3-8-T10-MC) AND ONE NON-MEDTRONIC COIL. THE ANEURYSM WAS INCOMPLETELY OCCLUDED. THE AUTHORS RATED THE ARTIFACTS ON A POST-EMBOLIZATION MRA AS GRADE 2. PATIENT 14 (MALE, (B)(6)) UNDERWENT EMBOLIZATION OF A BASILAR ARTERY ANEURYSM USING TEN NEXUS COILS (X-8-25-T10-MC, X-6-20-T10-MC, X-6-20-T10-MC, X-6-20-T10-HSS, X-5-15-T10-MC, X-5-15-T10-MC, X-4-10-T10-MC, X-3-8-T10-MC, X-2-8-T10-HSS, X-2-6-T10-HSS). THE ANEURYSM WAS NEAR-COMPLETELY OCCLUDED. THE AUTHORS RATED THE ARTIFACTS ON A POST-EMBOLIZATION MRA AS GRADE 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690658 NEXUS COIL DEVICE, NEUROVASCULAR EMBOLIZATION HCG COVIDIEN (IRVINE) X-2-8-T10-HSS

    Patients

    Seq Age Sex Outcome Treatment
    1