BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUFILL DCS ORBIT MINI COMPLEX FILL

    MDR report key: 1051664 · Received May 21, 2008

    Report

    Report Number
    1058196-2008-00137
    Event Type
    Injury
    Date Received
    May 21, 2008
    Date of Event
    March 21, 2008
    Report Date
    March 22, 2008
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    HCG
    PMA / PMN Number
    K053197
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CD'S WERE REVIEWED BY AN INDEPENDENT PHYSICIAN. THE REASON OF THE ANEURYSM RUPTURE IS UNKNOWN. THE COILS USED WHILE THE RUPTURE OCCURRED WERE ORBIT COILS. THE OPERATOR CLEARLY ADVANCED THE PUSHER OF COIL #2 SEVERAL MILLIMETERS TOO FAR, BUT THIS HAPPENED ONLY AFTER (DOCUMENTED) RUPTURE OF THE ANEURYSM. THIS OPERATOR ERROR WITH COIL #2 RESULTED IN COIL PROTRUSION THROUGH THE WALL OF THE ANEURYSM. COIL 2 DETACHED NORMALLY. COIL #4 WAS AGAIN LOOPING OUTSIDE THE PHYSICAL LIMITS OF THE ANEURYSM WALL. IN ADDITION, THIS COIL STRETCHED, IN MY OPINION IN A CONVENTIONAL WAY. I DON'T SEE ANY INDICATION OR VISUAL SIGN OF EARLY DETACHMENT. THE REASON OF THE STRETCHING WAS MANIPULATION WITH THE MICROCATHETER AND THE GUIDE CATHETER BECAUSE THE CATHETER TIP WAS KICKED OUT OF THE ANEURYSM DURING COILING. THE COIL STRETCHED AND WAS PULLED INTO THE GUIDE CATHETER WHERE IT LATER DETACHED FROM THE PUSHER. THE UNSECURED, STRETCHED COIL LATER WAS EJECTED BY MULTIPLE CONTRAST INJECTIONS VIA THE NEURON INTO THE ICA. THERE WAS A TIME WINDOW BETWEEN 14:08 AND 14:36 WHEN THE COIL COULD HAVE BEEN REMOVED RELATIVELY EASILY WHILE IN THE GUIDE CATHETER. LATER THE MASS MIGRATED INTO THE MCA AND CAUSED CLOTTING AND CONSEQUENT OCCLUSION. DRUG INFUSION AND MECHANICAL CLOT RETRIEVAL WAS PERFORMED SUCCESSFULLY, FOLLOWED BY AN APPARENTLY NOT COMPLETELY SUCCESSFUL ATTEMPT TO REMOVE THE STRETCHED COIL MECHANICALLY WITH MERCI. THIS IS ONE OF TWO PRODUCTS USED ON THE SAME PT. MFR REPORT # 1058196-2008-00097.

    Description of Event or Problem · 1

    ADDITIONAL INFO REGARDING 2ND COIL. THE FEMALE WITH HUNT-HESS 3 FISCHER 3 SUBARACHNOID HEMORRHAGE (SAH) PRIOR TO THE PROCEDURE WAS UNDERGOING A COIL EMBOLIZATION OF A 5 MM NARROW NECKED ANEURYSM OF THE RIGHT INTERNAL CAROTID ARTERY (ICA) AT THE REGION OF THE POSTERIOR COMMUNICATING ARTERY (PCOM). IT WAS REPORTED THAT THE ORBIT COIL BOTH STRETCHED AND DETACHED, OR THE DISTAL PLASTIC PART OF THE DELIVERY SYSTEM DETACHED. WITH FOLLOW-UP INVESTIGATION, IT WAS REPORTED THAT PRIOR TO THIS OCCURRING, THERE WAS AN ANEURYSM RUPTURE AND THROMBOEMBOLIC EVENT. PER THE OPERATING PHYSICIAN AND FILM REVIEWER ANEURYSM RUPTURE IS NOT RELATED TO THIS #2 COIL. THE PT HAD A LACUNAR INFARCT OF THE RIGHT IC RESULTING IN A LEFT ARM PARESIS THAT HAS RESOLVED. THE PT HAS MILD MEMORY LOSS AND MILD DISORIENTATION, WHICH IS AN IMPROVEMENT OF THE BASELINE AT INITIAL PRESENTATION. DIAGNOSTIC ANGIOGRAM DEMONSTRATED THREE ANEURYSMS OF THE RIGHT CAROTID CIRCULATION: AN APPROXIMATELY 4MM ANEURYSM IN THE REGION OF THE ANTERIOR COMMUNICATING ARTERY (ACOM)/RIGHT A2 JUNCTION, WHICH IS LOBULATED AND POINTS SUPERIORLY AND ANTEROLATERALLY, A 4.5MM ANEURYSM OF THE RIGHT ICA IN THE REGION OF THE PCOM., WHICH IS SMOOTH, DOMED WITH A NARROW NECK. A 3MM ANEURYSM OF THE RIGHT MIDDLE CEREBRAL (MCA) ARTERY BIFURCATION WITH A BRANCH TO THE ANTERIOR TEMPORAL LOBE ORIGINATING FROM THE PROXIMAL DOME OF THE ANEURYSM. THE DECISION WAS MADE TO PROCEED WITH COIL EMBOLIZATION OF THE ACOM ANEURYSM AND RIGHT PCOM REGION ANEURYSM. THERE WAS NO VESSEL CALCIFICATION, TORTUOSITY OR BENDS. THE FIRST COIL WAS DEPLOYED INTO THE PCOM ANEURYSM SUCCESSFULLY. DURING PLACEMENT OF THE SECOND COIL, THE PT BECAME BRADYCARDIAC AND HYPERTENSIVE. CONTRAST EXTRAVASATION WAS NOTED WITH AN IMMEDIATE ANGIOGRAM. THE COIL WAS DETACHED AND WAS FOLLOWED BY IMMEDIATE PLACEMENT OF TWO MORE COILS, WHICH STOPPED THE EXTRAVASATION. THE PHYSICIAN REPORTED THAT IT IS NOT BELIEVED THAT ANY DEVICES CONTRIBUTED TO THE RUPTURE. COIL EMBOLIZATION CONTINUED. DURING PLACEMENT OF THE FINAL COIL, IT APPEARS THAT THE COIL BOTH STRETCHED AND, DETACHED, OR THE DISTAL PLASTIC PART OF THE DELIVERY SYSTEM DETACHED. THERE WAS NO DIFFICULTY PREPPING THE COIL PRIOR TO USE, NO RESISTANCE ENCOUNTERED DURING INSERTION OF THE COIL THROUGH THE MICROCATHETER AND A CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. THE COIL WAS BEING ADVANCED INTO THE ANEURYSM WHEN THE EVENT OCCURRED AND PRIOR AT ATTEMPTED WITHDRAWAL THERE WAS A LOSS OF ONE-ONE CORRESPONDENCE WITH THE COIL. NO EXCESSIVE TORQUE OR MANIPULATION WAS USED OR REQUIRED. THERE WAS NO RESISTANCE PRIOR TO THE EVENT. THE COIL WAS NEARLY COMPLETED DEPLOYED FROM THE MICROCATHETER. THE MICROCATHETER WAS NOT REPOSITIONED OVER THE DEPLOYED COIL. THE PART OF THE COIL, OR COIL/DELIVERY TUBING THAT PROTRUDED FROM THE ANEURYSM WAS RETRIEVED WITH A CONCENTRIC MERCI RETRIEVER. THIS RESULTED IN PROTRUSION INTO THE PARENT VESSEL. AN ATTEMPT TO RETRIEVE THIS COIL WAS UNSUCCESSFUL AND THE MASS OF THE MATERIAL EMBOLIZED DISTALLY INTO THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) AT THE MCA BIFURCATION. ANGIOGRAM DEMONSTRATED EARLY THROMBUS FORMATION WITHOUT OCCLUSION OF FLOW. THIS WAS TREATED WITH REOPRO AND MECHANICAL REMOVAL. AS THE MASS OF MATERIAL WAS REMOVED WITH MERCI RETRIEVAL, THE STRETCHED PORTION OF THE COIL DETACHED FROM THE COIL PACK AND PROTRUDED INTO THE PARENT VESSEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRUFILL DCS ORBIT MINI COMPLEX FILL CNV DCS ORBIT (HCG) HCG CORDIS NEUROVASCULAR, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention MC