BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APOLLO

    MDR report key: 17410368 · Received July 27, 2023

    Report

    Report Number
    2029214-2023-01206
    Event Type
    Malfunction
    Date Received
    July 27, 2023
    Date of Event
    October 25, 2020
    Report Date
    July 27, 2023
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    MFE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID :UNK-NV-APOLLO. G2: CITATION: AUTHORS: MOHAMED S, VILLABONA A, KENNION O, PADMANANBHAN R, SIDDIQUI A, KHAN S, PRASAD M, MUKERJI N. MIDDLE MENINGEAL ARTERY EMBOLISATION FOR CHRONIC SUBDURAL HAEMATOMAS: THE FIRST PROSPECTIVE UK STUDY. BRITISH JOURNAL OF NEUROSURGERY 36:6, 786-791 2022. 10.1080/02688697.2022.2097200. 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 IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. 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.

    Description of Event or Problem · 0

    MMA EMBOLIZATION HAS EMERGED IN RECENT YEARS AS A SAFE ENDOVASCULAR TREATMENT FOR CHRONIC SUBDURAL HEMATOMA. WE REPORT THE FIRST UK SERIES OF ENDOVASCULAR TREATMENT OF CHRONIC SUBDURAL HEMATOMAS. ALL ADULT PATIENTS REFERRED WITH MIDLINE SHIFT LESS THAN OR EQUAL TO 10MM AND GCS 13 WERE CONSIDERED. PATIENTS HAD TO BE MOBILE WITH A STANDARD ORIGIN OF MIDDLE MENINGEAL AND OPHTHALMIC ARTERIES. PATIENTS WITH GCS 13 OR PROFOUND WEAKNESS (MRC GRADE LESS THAN OR EQUAL TO 3) WERE TREATED WITH BURR HOLE DRAINAGE AND PLACEMENT OF SUBDURAL DRAINS.   PATIENTS WERE RECRUITED OVER A 14-MONTH PERIOD FROM 25 OCTOBER 2020 TO 25 DECEMBER 21 THROUGH OUR ELECTRONIC REFERRAL SYSTEM. PATIENTS¿ DEMOGRAPHICS, PRE-MORBID MODIFIED RANKIN SCORE (MRS), SYMPTOMS; ANTICOAGULATION AND CO-MORBIDITIES WERE PROSPECTIVELY COLLECTED. SUITABILITY FOR ENDOVASCULAR TREATMENT WAS DISCUSSED WITH THE INTERVENTIONAL NEURORADIOLOGIST AND NEUROSURGEON. SQUID-12 EMBOLIC MA TERIAL WAS USED FOR ALL MMA EMBOLIZATION, WHICH WAS PERFORMED UNDER GENERAL ANESTHETIC. BASELINE CT/MRI CHARACTERISTICS WERE COLLECTED. FURTHER IMAGING WAS OBTAINED AT 7, 21, 90 AND 180 DAYS. CLINICAL ASSESSMENT AND MRS WAS COMPLETED AT THREE MONTHS. FIFTEEN PATIENTS UNDERWENT ENDOVASCULAR EMBOLIZATION OF MMA IN THE STUDY PERIOD. OF THESE 13 WERE MALE, MEDIAN AGE WAS 79 YEARS. MEDIAN LENGTH OF STAY WAS FOUR DAYS. FOLLOW-UP CT AT THREE MONTHS HAS DEMONSTRATED SIGNIFICANT REDUCTION IN BOTH MIDLINE SHIFT AND MAXIMUM THICKNESS OF HEMATOMA. NINE PATIENTS HAD REACHED THE THREE MONTHS¿ FOLLOW-UP PERIOD. ALL OF THEM HAD COMPLETE OR NEAR-COMPLETE RESOLUTION OF THE CSDH.   ONE PATIENT HAD PERSISTENT HEADACHES TWO MONTHS FOLLOWING PROCEDURE AND REPEAT IMAGING SHOWED WORSENING MASS EFFECT. THIS PATIENT THEN WENT ON TO HAVE MINI-CRANIOTOMY AND EVACUATION OF CSDH. THERE WERE TWO PROCEDURE-RELATED COMPLICATIONS AND ONE NONPROCEDURAL RELATED COMPLICATION; ONE PATIENT HAD A RETAINED MICRO CATHETER THAT COULD NOT BE DETACHED AT THE END OF THE EMBOLIZATION. THE PATIENT MADE A GOOD RECOVERY AND WAS ALREADY ON LIFELONG ASPIRIN, WHICH WAS CONTINUED AFTER THE PROCEDURE. THE OTHER PROCEDURE RELATED COMPLICATION WAS A SMALL EXTRADURAL HEMATOMA SECONDARY TO RUPTURE OF ONE OF THE DISTAL BRANCHES OF THE MMA. THIS HAD NO CLINICAL SIGNIFICANCE AND HEMATOMA COMPLETELY RESOLVED ON FURTHER IMAGING. PATIENT 2 HAD PERIOPERATIVE COVID-19 PNEUMONIA AND SUBSEQUENTLY DIED ON THE SEVENTH POSTOPERATIVE DAY.   FOR SELECT PATIENTS, MMA EMBOLIZATION IS A SAFE ALTERNATIVE TREATMENT OPTION FOR CHRONIC SUBDURAL HEMATOMA. AS WE GAIN MORE EXPERIENCE, THE PROCEDURE COULD BE PERFORMED UNDER LOCAL ANESTHETIC.   ADVERSE EVENTS INCLUDED: 1. PERSISTENT HEADACHES; 2. WORSENING MASS EFFECT; 3. SMALL EXTRADURAL HEMATOMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    817017 APOLLO AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-APOLLO UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male SEE H10...