BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APOLLO

    MDR report key: 17289386 · Received July 10, 2023

    Report

    Report Number
    2029214-2023-01061
    Event Type
    Injury
    Date Received
    July 10, 2023
    Date of Event
    April 13, 2023
    Report Date
    July 10, 2023
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    MFE
    PMA / PMN Number
    P030004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G2: CITATION: AUTHORS: LU, D., LI, Y., YANG, Z., ZHAO, Z., FANG, W., CHEN, L., MA, T., WANG, N., LI, X., ZHANG, T., <(>&<)> DENG, J.. APPLICATION OF THE PRESSURE COOKER TECHNIQUE FOR TRANSARTERIAL EMBOLIZATION OF BRAIN ARTERIOVENOUS MALFORMATIONS: FACTORS AFFECTING OBLITERATION AND OUTCOMES. FRONTIERS IN NEUROLOGY 14:1133091 2023. DOI:10.3389/FNEUR.2023.1133091 A.2. THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. A.3. THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. 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. G2: THE COUNTRY OF THE EVENT IS CN. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    LU D, LI Y, YANG Z, ET AL. APPLICATION OF THE PRESSURE COOKER TECHNIQUE FOR TRANSARTERIAL EMBOLIZATION OF BRAIN ARTERIOVENOUS MALFORMATIONS: FACTORS AFFECTING OBLITERATION AND OUTCOMES. FRONTIERS IN NEUROLOGY. 2023;14:1133091. DOI:10.3389/FNEUR.2023.1133091 MEDTRONIC LITERATURE REVIEW FOUND A REPORT OF PATIENT COMPLICATIONS IN ASSOCIATION WITH MARATHON CATHETER, APOLLO CATHETER, AND ONYX. THE PURPOSE OF THIS ARTICLE WAS TO ASSESS THE EFFECTIVENESS OF TRANSARTERIAL EMBOLIZATION OF BRAIN ARTERIOVENOUS MALFORMATIONS (BAVMS) WITH THE PRESSURE COOKER TECHNIQUE (PCT). THE PRESSURE COOKER TECHNIQUE (PCT), FIRST DEVELOPED BY CHAPOT ET  AL. TO GENERATE AN ANTI-REFLUX PLUG OF COILS AND GLUE, ENABLES A CONTINUOUS ONYX INJECTION INTO THE NIDUS WHILE STEERING CLEAR OF UNACCEPTABLE REFLUX, THEREBY IMPROVING THE RATE OF CURATIVE EMBOLIZATION. FROM JANUARY 2019 TO DECEMBER 2021, 125 CONSECUTIVE PATIENTS WITH BAVM MANAGED BY TRANSARTERIAL EMBOLIZATION IN THE PROSPECTIVE DATABASE ON CEREBRAL VASCULAR DISEASES OF A SINGLE CENTER WERE RETROSPECTIVELY REVIEWED. THERE WERE 81 MALES AND 44 FEMALES WITH AN AVERAGE AGE OF 31.5 YEARS. ALL PATIENTS WERE EMBOLIZED EXCLUSIVELY WITH ONYX 18 IN AN ATTEMPT TO ACHIEVE COMPLETE OCCLUSION OF THE NIDUS IN THE FIRST PROCEDURE. FOR THE PTC, AFTER FEMORAL ARTERIAL ACCESS, A 6FR GUIDE CATHETER WAS USED FOR THE CATHETERIZATION OF THE TARGET ARTERY, AND FULL SELECTIVE DSA WAS CARRIED OUT PRIOR TO EVERY TREATMENT. FOR THE PCT, TWO MICROCATHETERS WERE POSITIONED IN THE SELECTED FEEDER. THE FIRST MICROCATHETER (MARATHON, EV3; APOLLO, EV3; SONIC, BALT) WAS SUPER-SELECTIVELY ADVANCED TO A SUITABLE LOCATION OF THE SELECTED FEEDER ACCORDING TO THE OPERATOR¿S EXPECTATION. TO CREATE A PLUG OF COILS, THE SECOND MICROCATHETER (SL-10, STRYKER; HEADWAY-17, MICROVENTION) WAS NAVIGATED JUST PROXIMAL TO THE TIP OF MARATHON IN THE SAME FEEDER. COILS WERE DEPLOYED AS CLOSE AS POSSIBLE TO THE TIP OF THE FIRST MICROCATHETER TO AVOID DIFFICULTY IN PULLING THE MICROCATHETER. THE NUMBER OF DEPLOYED COILS NEEDED TO ACHIEVE THE HIGHEST PACKING DENSITY WAS DECIDED BY THE FEEDER¿S CALIBER. THE LAST COIL WAS NOT DETACHED UNTIL THE PLUG WAS S TABLE ENOUGH. THIS WAS FOLLOWED BY SLOW AND GRADUAL INJECTION OF ONYX INTO THE NIDUS, WITH CONTINUOUS MONITORING BY BIPLANE SUBTRACTED FLUOROSCOPY. ONCE REFLUX ALONG THE MICROCATHETER WAS OBSERVED, THE INJECTION WAS DISCONTINUED FOR A FEW SECONDS AND THEN RESUMED. THIS WAY, A PLUG WAS CREATED, FORMING A PERMANENT BARRIER TO PREVENT REFLUX. RIGHT AFTER EMBOLIZATION COMPLETION AND MICROCATHETER RETRIEVAL, GLOBAL CONTROL ANGIOGRAPHY WAS PERFORMED. FOR THE CONVENTIONAL EMBOLIZATION TECHNIQUE (CET), ONE MICROCATHETER WAS ADVAN CED IN THE SELECTED FEEDER WITH THE TIP OF MICROCATHETER POSITIONED AS CLOSE AS POSSIBLE TO THE NIDUS OF BAVM. NO COILS WERE USED FOR CREATING THE ANTI-REFLUX PLUG. A ¿PLUG-AND-PUSH TECHNIQUE,¿ WAS USED, WHICH CONSISTS OF FRACTIONATED INJECTIONS OF ONYX WITH PAUSES OF 30¿40S WHEN ONYX REACHES THE ORIGIN OF THE NIDAL VEINS OR IT REFLOWS INTO THE ARTERIAL FEEDER TOWARD THE MICROCATHETER. THE MICROCATHETER WOULD BE REMOVED AFTER THE EMBOLIZATION OR WHEN THE REFLUX EXCEEDED 2.0CM OR BEYOND THE DETERMINED LENGTH. IF NECESSARY, A NEW MICROCATHETER WAS POSITIONED INTO ANOTHER PEDICLE AND EMBOLIZATION WAS CONTINUED IN THE SAME WAY. THERE WERE 46 AND 79 PATIENTS IN THE PCT AND CET GROUPS, RESPECTIVELY. THE ARTICLE DOES NOT STATE ANY TECHNICAL ISSUES DURING USE OF THE ONYX, MARATHON CATHETER, OR APOLLO CATHETER. THE FOLLOWING INTRA- OR POST-PROCEDURAL OUTCOMES WERE NOTED: - ONE PATIENT WITH BRAINSTEM-FOURTH VENTRICLE AVM IN THE CET GROUP DIED OF MEDULLARY INFARCTION AFTER EMBOLIZATION. - PROCEDURE-RELATED COMPLICATIONS, INCLUDING INTRA-OPERATIVE HEMORRHAGE, POST-OPERATIVE HEMORRHAGE, AND CEREBRAL ISCHEMIA, OCCURRED IN 6 PATIENTS ADMINISTERED THE PCT VERSUS 8 IN THE CET GROUP; 3 PATIENTS EXPERIENCED INTRAOP ICH, 6 EXPERIENCED POSTOP ICH, AND 5 PATIENTS EXPERIENCED CEREBRAL ISCHEMIA - THE HEMORRHAGIC EVENTS CAUSED DETERIORATION IN MRS SCORES FOLLOWING EMBOLIZATION IN FOUR PATIENTS OF THE PCT GROUP VERSUS TWO PATIENTS OF THE CET GROUP. IN THESE SIX PATIENTS, 3 HAD A CHANGE OF THREE POINTS IN MRS SCORE, AND THE REMAINING THREE PATIENTS HAD A CHANGE OF =4 POINTS. 112 PATIENT HAD MRS SCORE OF LESS THAN 3 AND 13 WITH A MRS SCORE GREATER THAN OR EQUAL TO 3 - ONE PATIENT EACH IN THE PCT AND CET GROUPS WERE TREATED BY EXTERNAL VENTRICLE DRAINAGE AFTER EMBOLIZATION. - THREE AND ONE PATIENTS IN THE PCT AND CET GROUPS, RESPECTIVELY, WERE TREATED BY EMERGENCY HEMATOMA EVACUATION AFTER EMBOLIZATION. - TWO AND THREE PATIENTS IN THE PCT AND CET GROUPS, RESPECTIVELY, HAD CEREBRAL ISCHEMIA AFTER EMBOLIZATION. - NEUROLOGICAL DEFICITS OCCURRED IN ONE PATIENT OF THE CET GROUP. - THREE PATIENTS WITH CEREBRAL ISCHEMIA WERE CONSERVATIVELY TREATED WITH MEDICATIONS AND THEIR NEUROLOGIC STATUS DID NOT CHANGE - COMPLETE OBLITERATION IMMEDIATELY AFTER EMBOLIZATION WAS DETECTED IN 61 AND 42% OF PATIENTS IN THE PCT AND CET GROUPS, RESPECTIVELY - WITH THE RESULTS THAT BAVMS WERE COMPLETELY OCCLUDED, BAVM RECURRENCE OCCURRED IN ONE PATIENT OF THE PCT GROUP VERSUS THREE IN THE CET GROUP; IN THE CASES IN WHICH THE BAVM WAS NOT COMPLETELY OCCLUDED, PATIENTS UNDERWENT COMPLEMENTARY TREATMENT INCLUDING STAGED EMBOLIZATION, NEUROSURGERY AND RADIOSURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180153 APOLLO AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-APOLLO UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Male Required Intervention| L