BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIUM

    MDR report key: 19240383 · Received May 3, 2024

    Report

    Report Number
    2029214-2024-00854
    Event Type
    Injury
    Date Received
    May 3, 2024
    Date of Event
    December 24, 2023
    Report Date
    May 3, 2024
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    HCG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID PED-475-18 (UNKNOWN); PRODUCT TYPE: ; IMPLANT DATE ; EXPLANT DATE PRODUCT ID PED-450-16 (UNKNOWN); PRODUCT TYPE: ; IMPLANT DATE ; EXPLANT DATE PRODUCT ID PED-475-18 (UNKNOWN); PRODUCT TYPE: ; IMPLANT DATE ; EXPLANT DATE PRODUCT ID PED-500-35 (UNKNOWN); PRODUCT TYPE: ; IMPLANT DATE ; EXPLANT DATE G2: CITATION: AUTHORS: ROGERS, P. S., VOLDERS, D., PICKETT, G., <(>&<)> VANDORPE, R.. COIL MIGRATION THROUGH TWO FLOW-DIVERTING STENTS. BMJ CASE REPORTS 17(1) 2024. DOI:10.1136/BCR-2023-256863 EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED. WITHOUT RETURN OF THE PRODUCT NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATIONS. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    ROGERS PS, VOLDERS D, PICKETT G, VANDORPE R. COIL MIGRATION THROUGH TWO FLOW-DIVERTING STENTS. BMJ CASE REPORTS. 2024;17(1). DOI:10. 1136/BCR-2023-256863 MEDTRONIC LITERATURE REVIEW FOUND A REPORT OF PATIENT COMPLICATIONS IN ASSOCIATION WITH PIPELINE EMBOLIZATION DEVICE AND AXIUM COIL. THE PURPOSE OF THIS ARTICLE WAS TO REPORT A POTENTIAL COMPLICATION DURING NEUROINTERVENTIONAL PROCEDURES USING THESE DEVICES. THE FOLLOWING INTRA- OR POST-PROCEDURAL OUTCOMES WERE NOTED: A PIPELINE FLEX 4.75×18 MM FLOW DIVERTER (FD) WAS PARTIALLY DEPLOYED AND THE EMBOLIZATION COILS WERE INSERTED INTO THE ANEURYSM. THIS WAS FOLLOWED BY THE COMPLETE DEPLOYMENT OF THE FD IN THE CONVENTIONAL STENT-ASSISTED COILING (SAC) TECHNIQUE. IN TOTAL, 8 MICROVENTION MICROPLEX AND 10 MICROVENTION COILS WERE NECESSARY TO ACHIEVE ANEURYSM STASIS. THE OPERATORS DECIDED TO DEPLOY A LARGER NUMBER OF SMALLER COILS DUE TO CONCERNS ABOUT LOSING ACCESS TO THE ANEURYSM WITH THE MICROCATHETER. THERE WAS COMPLETE OBLITERATION (RAYMOND-ROY CLASS 1) WITH THE FD LANDING ZONE RUNNING FROM THE ICA TERMINUS TO THE CAVERNOUS ICA. A DIAGNOSTIC CEREBRAL ANGIOGRAM 1 YEAR LATER SHOWED A 7 MM RECURRENCE OF THE ANEURYSM SUPPLIED BY A LARGE POSTERIOR COMMUNICATING ARTERY (PCOM). DUE TO THE SIZE AND RAPIDITY OF THE ANEURYSM¿S RECURRENCE, IT WAS CLASSIFIED AS A DISSECTING ANEURYSM, WHICH WOULD EXPLAIN WHY THE INITIAL TREATMENT WAS INEFFECTIVE. A PLAN WAS MADE TO ADDRESS THE RECURRENT ANEURYSM WITH REPEAT FD INSERTION AND POTENTIAL PCOM VESSEL SACRIFICE. A PHENOM 27 MICROCATHETER WAS ADVANCED PAST THE BLISTER ANEURYSM, AND A SECOND PIPELINE FLEX 4.5×16 MM FD WAS SUCCESSFULLY DEPLOYED WITHIN THE FIRST FD FROM THE CAROTID TERMINUS TO THE CAVERNOUS ICA, AGAIN COVERING THE NECK OF THE ANEURYSM. DESPITE THE SECOND FD COVERING THE ANEURYSM, THERE WAS STILL INSUFFICIENT ANEURYSM STASIS. THEREFORE, THE PLAN WAS TO ACCESS THE ANEURYSM FROM THE POSTERIOR CIRCULATION VIA THE FEEDING PCOM WITH A SL-10 MICROCATHETER AND COIL THE ANEURYSM RECURRENCE. UNFORTUNA TELY, THE MICROCATHETER WAS NOT ABLE TO ADVANCE FROM THE DISTAL PCOM INTO THE ANEURYSM AND THE DECISION WAS MADE TO COIL FROM THAT LOCATION TO OCCLUDE INFLOW FROM THE DISTAL PCOM. IT WAS REASONED THAT THIS MANEUVER WAS SAFE BECAUSE THE ICA WAS PROTECTED BY THE TWO FDS. DURING THE DEPLOYMENT OF THE FIRST AXIUM PRIME 4×12 MM HELICAL COIL, DISTAL COIL MIGRATION THROUGH THE MESH OF THE SUPERIMPOSED FD INTO THE LEFT M1 OVER A LENGTH OF APPROXIMATELY 3.0 CM WAS SEEN. THE COIL MIGRATED QUICKLY INTO THE FD LUMEN, PUNCTURING THROUGH THE FD MESH AS IF UNDER TENSION. THE COIL THEN BEGAN TO PULSATE WITH EACH HEARTBEAT, CONFIRMING THAT IT WAS NOT JAILED BETWEEN THE FD AND THE VESSEL WALL. UNSUCCESSFUL RETRIEVAL EFFORTS WITH A MICROSNARE RESULTED IN STRETCHING OF THE PROXIMAL PART OF THE COIL. TO CORRECT THIS, A THIRD PIPELINE FLEX 4.75×18 MM FD WAS PARTIALLY DEPLOYED INTO THE MID-M1 SEGMENT WHICH SECURED THE DISTAL MIGRANT COIL LOOP. WHILE PULLING BACK THE FD, THE COIL WAS CAPTURED AND BROUGHT BACK INTO THE ICA TERMINUS. THE REST OF THE FD WAS THEN FULLY DEPLOYED, JAILING THE COIL BETWEEN THE SECOND AND THIRD FD, COVERING THE ANEURYSM NECK. USING A MICROSNARE, MUCH OF THE COIL WAS RETRIEVED. A CONTROL ANGIOGRAM DEMONSTRATED MORE STAGNATION OF CONTRAST WITHIN THE ANEURYSM, AND THE DECISION WAS MADE TO NOT REATTEMPT THE PCOM SACRIFICE. DURING THE REMOVAL OF THE INSTRUMENTS, A CONTROL RUN DEMONSTRATED A FLOW-LIMITING DISSECTION FROM THE DISTAL V3 TO THE PROXIMAL V4 SEGMENT WITH A GROWING PSEUDOANEURYSM. A PIPELINE FLEX 5×35 MM FD WAS DEPLOYED COVERING THE DISSECTION. A CONTROL ANGIOGRAM DEMONSTRATED COMPLETE RECANALIZATION OF THE DOMINANT LEFT VERTEBRAL ARTERY. A FINAL CONTROL ANGIOGRAM FROM THE LEFT VERTEBRAL ARTERY AND THE LEFT CCA DID NOT DEMONSTRATE ANY DISTAL EMBOLI. THE FOLLOWING DAY THE PATIENT DEVELOPED RIGHT ARM WEAKNESS AND APHASIA. SMALL INFARCTS WERE FOUND WITHIN THE LEFT BASAL GANGLIA, FRONTAL LOBE AND CEREBELLUM. THE PATIENT MADE A FULL NEUROLOGICAL RECOVERY. GIVEN THE PERSISTENT PRESENCE OF THE ANEURYSM DESPITE THE PLACEMENT OF THREE FDS, THE PATIENT SUBSEQUENTLY UNDERWENT OPEN SURGERY WITH SUCCESSFUL ANEURYSM CLIPPING 2 WEEKS LATER. THE PATIENT¿S CLINICAL CONDITION DID NOT CHANGE OVER THE NEXT 3 YEARS, AND THEY CONTINUE TO BE WELL. IT WAS NOTED IN THE ARTICLE THAT THE NOMINAL DIAMETER OF AN AXIUM PRIME 4×12 MM HELICAL COIL TIP IS 0.012 INCHES (305 ¿M). THE PORE SIZE FOR THE PIPELINE FLEX FD IS A RANGE BETWEEN 200 AND 300 ¿M DEPENDING ON THE SIZE OF THE VESSEL IT IS DEPLOYED WITHIN. ASSUMING THE FD WAS DEPLOYED IN A LARGE INTRACRANIAL VESSEL (ICA), ALLOWING FOR THE PORE SIZE TO REACH THE MAXIMUM EXTENT. THIS MEANS THAT THE COIL TIP IS STILL UNLIKELY TO PASS THROUGH THE WALL OF THE STENT GIVEN THAT THE COIL IS ALWAYS LARGER THAN THE PORE DIAMETER. HOWEVER, IF FORCE IS APPLIED AND THE ANGLE IS OPTIMIZED, THE WIRES IN THE BRAID WILL MOVE TO ACCOMMODATE THE PRESSURE IMPOSED BY THE COIL. IN THE REPORTED CASE, THE VESSEL CONTAINED TWO SUPERIMPOSED FDS, WHICH MADE IT EVEN MORE UNLIKELY FOR MIGRATION TO OCCUR AS THE COIL HAD TO PASS THROUGH TWO BARRIERS IN THIS FASHION. THE AUTHORS PROPOSED TWO FACTORS THAT MAY HAVE CONTRIBUTED TO THIS COMPLICAT ION. THE FIRST IS THE ANGLE OF APPROACH. WHEN THE COIL WAS DEPLOYED, THE MICROCATHETER DELIVERY SYSTEM WAS PLACED AT A 90° ANGLE FROM THE PCOM IN RELATION TO THE FD IN THE ICA. IF THE MICROCATHETER HAD BEEN PLACED AT AN ANGLE AWAY FROM THE STENT, AS IS DONE DURING MOST STENT-JAIL TECHNIQUES, THE COIL LOOP MAY HAVE INSTEAD REBOUNDED OFF THE SIDE OF THE FD. THE SECOND FACTOR IS SUPPORT. WHEN THE COIL WAS DELIVERED, THE MICROCATHETER WAS NEAR-ADJACENT TO THE FD. IN THIS CONFIGURATION, THE MICROCATHETER WAS ABLE TO STABILIZE THE COIL AND KEEP IT STRAIGHT UNTIL IT PENETRATED THE FD. IF THE COIL HAD BEEN DELIVERED FARTHER AWAY FROM THE FD, IT LIKELY WOULD HAVE STARTED BREAKING INTO LOOPS WHICH WOULD HAVE REDUCED THE LIKELIHOOD OF PENETRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123818 AXIUM DEVICE, NEUROVASCULAR EMBOLIZATION HCG MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-AXIUM UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention