BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLITAIRE REVASCULARIZATION DEVICE

    MDR report key: 6742530 · Received July 25, 2017

    Report

    Report Number
    2029214-2017-00919
    Event Type
    Injury
    Date Received
    July 25, 2017
    Date of Event
    November 24, 2015
    Report Date
    July 6, 2017
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    NRY
    PMA / PMN Number
    K123378
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: G. B. BRADAC, F. VENTURI, G. STURA, M. CORIASCO, G. VENTILII, D. GARABELLO, M. BERGUI. CONSIDERATIONS ABOUT OCCLUSION OF THE INTRACRANIAL DISTAL INTERNAL CAROTID ARTERY. CLIN NEURORADIOL (2017) 27:169¿174. DOI 10.1007/S00062-015-0480-1. PUBLISHED ONLINE: 24 NOVEMBER 2015. THE PURPOSE OF THIS ARTICLE WAS TO REVIEW 8 PATIENTS (3 MALE, 5 FEMALE) WITH DISTAL INTERNAL CAROTID ARTERY (ICA) OCCLUSIONS THAT WERE TREATED ENDOVASCULARLY WITH THE SOLITAIRE (5 CASES), SOLITAIRE IN ASSOCIATION WITH ANOTHER THROMBECTOMY DEVICE (2 CASES), AND IN 1 PATIENT CONSERVATIVE TREATMENT WAS PERFORMED. IN ALL CASES THE INTERVAL BETWEEN STROKE AND EXAMINATION WAS 4-6 HOURS. THE COLLATERALS CAN BE IMPAIRED, BY DISTAL EMBOLIZATION AND BY ANOMALIES OF THE CIRCLE OF WILLIS: THE AIM OF THIS STUDY IS TO DESCRIBE THESE ASPECTS. THE AUTHORS CONCLUDE THAT THAT IN THE 2 TYPES OF DISTAL ICA OCCLUSION (COMPLETE AND PARTIAL ¿T¿), THE LEPTOMENINGEAL COLLATERAL CIRCULATION CAN BE THE SAME. IT IS ITS IMPAIRMENT DUE TO DISTAL EMBOLIZATION AND/OR ANOMALIES OF THE CIRCLE OF WILLIS WHICH CAN INFLUENCE NEGATIVELY THE FINAL RESULT. THE DEVICE WAS NOT RETURNED AS THIS EVENT WAS FOUND THROUGH LITERATURE REVIEW; THEREFORE, PRODUCT ANALYSIS OF THE SOLITAIRE DEVICES WAS NOT ABLE TO BE PERFORMED. BASED ON THE REPORTED INFORMATION, THE INFORMATION DID NOT REASONABLY SUGGEST A MALFUNCTION OR QUALITY DEFICIENCY OF THE SOLITAIRE DEVICES OCCURRED. THE CAUSE OF THE REPORTED EVENTS CANNOT BE RELIABLY DETERMINED; HOWEVER, PER THE REPORTED INFORMATION, REVIEW OF IFU, AND REVIEW OF LITERATURE TO INVESTIGATE THE COMPLAINT, IT IS MOST LIKELY A PROCEDURE RELATED EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, INCLUDING DEVICE AND PATIENT INFORMATION, HOWEVER NO INFORMATION HAS BEEN PROVIDED. SHOULD IT BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THROUGH LITERATURE REVIEW THAT 2 PATIENTS WITH OCCLUSIONS OF THE ICA AND M1, THAT RECEIVED MECHANICAL THROMBECTOMY FOR TREATMENT EXPERIENCED COMPLICATIONS. ONE PATIENT, EXPERIENCED A PARTIAL REVASCULARIZATION AND RECOVERED WITH MINIMAL DEFICIT. THE OTHER PATIENT EXPERIENCED PARTIAL REVASCULARIZATION, DISTAL EMBOLIZATION, DEVELOPED A LARGE HEMISPHERIC INFARCT AND REMAINS SEVERELY DISABLED. THE FIRST PATIENT PRESENTED WITH RIGHT HEMIPLEGIA AND APHASIA 5 HOURS AFTER A STROKE. THE PATIENT ALSO SHOWED ANOMALIES IN THE CIRCLE OF WILLIS. THE MECHANICAL THROMBECTOMY TREATMENT WITH THE SOLITAIRE AND OTHER THROMBECTOMY DEVICE (NON-MEDTRONIC) ALLOWED REOPENING OF THE DISTAL ICA AND OF THE FETAL PCA, ACHA, AND OF THE PROXIMAL M1. CT PERFORMED 24 HOURS LATER SHOWED INFARCT AT THE LEVEL OF THE BASAL GANGLIA. THE APHASIA RESOLVED RAPIDLY AND THERE WAS PROGRESSIVE IMPROVEMENT OF THE MOTOR DEFICIT IN THE FOLLOWING WEEKS. THE SECOND PATIENT WAS CARDIOPATHIC AND PRESENTED WITH LEFT HEMIPLEGIA AND AGITATION 5 HOURS AFTER STROKE. CT WAS NORMAL, BUT ANGIO-CT SHOWED OCCLUSION OF THE RIGHT DISTAL ICA WITH THE INVOLVEMENT OF THE M1. THIS PATIENT ALSO SHOWED ANOMALIES IN THE CIRCLE OF WILLIS. THE PATIENT WAS TREATED WITH THE SOLITAIRE AND ACHIEVED RAPID RECANALIZATION. HOWEVER, ON LATERAL ANGIOGRAM, THE DISTAL BRANCHES OF THE MCA WHERE SPARELY INJECTED WERE OCCLUDED BY EMBOLI, AND THE PATIENT DEVELOPED A LARGE INFARCT. THE PATIENT SURVIVED WITH A SEVERE HEMIPLEGIA AND HEMIANOPIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521852 SOLITAIRE REVASCULARIZATION DEVICE CATHETER, THROMBUS RETRIEVER NRY COVIDIEN (IRVINE) UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other