BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIUM DETACHABLE COIL

    MDR report key: 3439974 · Received October 31, 2013

    Report

    Report Number
    2029214-2013-00891
    Event Type
    Injury
    Date Received
    October 31, 2013
    Date of Event
    August 8, 2013
    Report Date
    October 2, 2013
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    HCG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION AS THEY WERE IMPLANTED IN THE PATIENT. THE DEVICES INVOLVED IN THE EVENT ARE AS FOLLOWS: MODEL: QC-10-30-3D, LOT: 9562426, DOM: 15-MAR-2012, EXP: 15-MAR-2015. MODEL: QC-9-30-3D, LOT: 9409248, DOM: 12-FEB-2011, EXP: 11-FEB-2014. MODEL: QC-9-30-3D, LOT: 9657724, DOM: 17-OCT-2012, EXP: 17-OCT-2015 . MODEL: QC-8-30-3D, LOT: 9492920, DOM: 22-SEP-2011, EXP: 21-SEP-2014 . MODEL: QC-8-30-3D, LOT: 9689080, DOM: 07-JAN-2013, EXP: 07-JAN-2016. MODEL: QC-8-30-HELIX, LOT: 9503593, DOM: 18-OCT-2011, EXP: 17-OCT-2014. MODEL: QC-7-30-3D, LOT: 9490479, DOM: 16-SEP-2011, EXP: 15-SEP-2014 2014. MODEL: QC-7-30-3D, LOT: 9666185, DOM: 06-NOV-2012, EXP: 06-NOV-2015. MODEL: QC-7-30-HELIX, LOT: 9400422, DOM: 19-JAN-2011, EXP: 18-JAN-2014. MODEL: QC-7-30-HELIX, LOT: 9494853, DOM: 27-SEP-2011, EXP: 26-SEP-2014. MODEL: QC-6-20-3D, LOT: 9695398, DOM: 21-JAN-2013, EXP: 21-JAN-2016 (QTY.2). MODEL: QC-6-20-HELIX, LOT: 9543578, DOM: 02-FEB-2012, EXP: 01-FEB-2015. MODEL: QC-6-20-HELIX, LOT: 9611075, DOM: 02-JUL-2012, EXP: 02-JUL-2015. MODEL: QC-6-15-3D, LOT: 9691362, DOM: 11-JAN-2013, EXP: 11-JAN-2016. (B)(4).

    Additional Manufacturer Narrative · 1

    RECEIVED ADDITIONAL INFORMATION ON (B)(4) 2013 STATING THAT THE PATIENT COMPLAINED ABOUT SYMPTOMS OF TRIGEMINAL NEURALGIA AT THE TIME OF FOLLOW UP ON (B)(6) 2013. THE PHYSICIAN HAS NOT BEEN ABLE TO DETERMINE IF THE SYMPTOM WAS CAUSED BY OR RELATED TO THE EMBOLIZATION TREATMENT. (B)(4).

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM THE (B)(4) STUDY. TREATMENT OF A GIANT SACCULAR ANEURYSM MEASURING 28.4MM LOCATED AT THE RIGHT CAVERNOUS SINUS. IT WAS REPORTED THAT THE PATIENT PRESENTED WITH SYMPTOMS OF OCULOMOTOR PARALYSIS UNDERWENT COILING EMBOLIZATION ON (B)(6) 2013 INVOLVING PENUMBRA PC400, TERUMO MICROPLEX, AND AXIUM IMPLANT COILS. DURING THE PROCEDURE, IT WAS REPORTED THAT TWO MICROCATHETERS WERE PLACED USING THE STENT (JAILING TECHNIQUE) FOLLOWED BY THE IMPLANTATION OF THE COILS. A FEW HOURS POST PROCEDURE, THE PHYSICIAN CONFIRMED THE PATIENT'S SYMPTOMS HAVE GOTTEN WORSE AND REQUIRED INTRAVENOUS INJECTION OF STEROIDS. THE PATIENT'S MRS (MODIFIED RANKIN SCORE) WAS GRADE 1 (NO SIGNIFICANT DISABILITY. ABLE TO CARRY OUT ALL USUAL ACTIVITIES, DESPITE SOME SYMPTOMS) BOTH DURING AND POST PROCEDURE. THE MRS BECAME GRADE 2 (SLIGHT DISABILITY, ABLE TO LOOK AFTER OWN AFFAIRS WITHOUT ASSISTANCE, BUT UNABLE TO CARRY OUT ALL PREVIOUS ACTIVITIES) AFTER 30 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559896 AXIUM DETACHABLE COIL DETACHABLE COIL HCG EV3 NEUROVASCULAR VARIOUS VARIOUS

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention| S