BEUDAMED
    FDA Adverse Event Death Summary report: N

    APOLLO 1.5 CM ONYX DELIVERY MICROCATHETER

    MDR report key: 7089271 · Received December 6, 2017

    Report

    Report Number
    2029214-2017-01332
    Event Type
    Death
    Date Received
    December 6, 2017
    Date of Event
    November 10, 2017
    Report Date
    February 12, 2018
    Manufacturer
    MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
    Product Code
    MFE
    PMA / PMN Number
    P030004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE EVENT HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE EVENT COULD NOT BE CONFIRMED. ONCE THE DEVICE IS RECEIVED, A SUPPLEMENTAL WILL BE SUBMITTED. 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.

    Additional Manufacturer Narrative · 1

    RECEIVED ADDITIONAL INFORMATION STATING THAT THE DEATH WAS DUE TO HEMORRHAGIC STROKE AFTER EMBOLIZATION OF THE AVM AND NOT DUE TO THE DEVICE. ALSO RECEIVED THE DATE OF DEATH FOR PATIENT AND UPDATED SECTION. THE DEVICE IS IN TRANSIT FOR EVALUATION. ONCE RECEIVED AND EVALUATED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE MICROCATHETER WAS RETURNED FOR ANALYSIS WITHOUT THE GUIDEWIRES AS THEY WERE DISCARDED AT THE SITE. THE GUIDEWIRES WERE FOUND TO BE COMPATIBLE WITH THE MICROCATHETER. THE MICROCATHETER WAS DECONTAMINATED AND THE USABLE AND FLOPPY DISTAL SEGMENTS OF THE MICROCATHETER WERE MEASURED TO BE WITHIN SPECIFICATIONS. NO ISSUES OR IRREGULARITIES WERE FOUND WITH THE MICROCATHETER HUB. NO KINKS OR BENDS WERE FOUND WITH THE MICROCATHETER BODY. THE DETACHABLE TIP WAS FOUND TO BE INTACT. THE SURFACE OF THE MICROCATHETER BODY WAS EXAMINED UNDER MAGNIFICATION. THE MICROCATHETER BODY WAS FOUND TO BE DISTENDED AND RUPTURED AT APPROXIMATELY 14.3CM FROM THE DISTAL TIP. THE MICROCATHETER WAS TESTED WITH AN IN-HOUSE GUIDEWIRE BY INSERTING IT INTO THE MICROCATHETER HUB; HOWEVER, IT COULD NOT PASS THROUGH THE DISTAL TIP AS IT BECAME STUCK NEAR THE DISTAL TIP. IT APPEARS THE MICROCATHETER IS OCCLUDED WITH WHAT IS LIKELY DRIED CONTRAST. THE MICROCATHETER WAS DISSECTED (CUT) DISTAL TO THE RUPTURED SITE AT APPROXIMATELY 13.5CM FROM THE DISTAL TIP. WHAT APPEARS TO BE DRIED CONTRAST WAS FOUND WITH THE SEPARATED END OF THE MICROCATHETER. NO OTHER ANOMALIES WERE OBSERVED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT THE FLOW DIRECTED MICROCATHETER HERNIATED AND RUPTURED DURING CONTRAST INJECTION IN THE RIGHT MIDDLE CEREBRAL ARTERY (MCA). THE MICROCATHETER RUPTURED IN THE PROXIMAL SEGMENT AND IT REMAINED INTACT. IT WAS ALSO REPORTED THAT THERE WAS FRICTION FELT DURING DELIVERY OF THE CATHETER. DUE TO TORTUOSITY AND FRICTION, THREE GUIDEWIRES WERE USED IN THE PROCEDURE. PRIOR TO THE EVENT, THE CATHETER WAS FLUSHED AND THERE WAS NO RESISTANCE WHEN THE CATHETER WAS ADVANCED THROUGH THE GUIDE CATHETER. THERE WAS SLIGHT FRICTION IN THE MIDDLE SECTION OF THE CATHETER WHEN THE GUIDEWIRES WERE ADVANCED, HENCE THREE GUIDEWIRES WERE USED ONE AFTER THE OTHER UNTIL THE GUIDEWIRE COULD BE ADVANCED ALL THE WAY THOUGH. THERE WAS NO FRICTION OR DIFFICULTY DURING THE INJECTION. THERE WAS NO VISIBLE DAMAGE TO THE DEVICE PRIOR TO USE. THE CONTRAST INJECTION WAS DONE SLOWLY. THE PATIENT WAS REPORTED TO HAVE A HEMORRHAGE LOCATED PROXIMAL TO THE EMBOLIZED NIDUS. THE PROCEDURE WAS COMPLETED BY TOTAL ANGIOGRAPHIC OCCLUSION OF ARTERIOVENOUS MALFORMATION (AVM). RECEIVED ADDITIONAL INFORMATION APPROXIMATELY THREE WEEKS POST PROCEDURE STATING THE PATIENT HAD EXPIRED. THE RELATIONSHIP TO THE DEVICE OR PROCEDURE WAS NOT PROVIDED. THE GUIDEWIRES WERE DISCARDED AT THE SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    868830 APOLLO 1.5 CM ONYX DELIVERY MICROCATHETER AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR 105-5095-000 A458084

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Death