BEUDAMED
    FDA Adverse Event Death Summary report: N

    REBAR

    MDR report key: 20316158 · Received September 26, 2024

    Report

    Report Number
    2029214-2024-01652
    Event Type
    Death
    Date Received
    September 26, 2024
    Date of Event
    May 23, 2024
    Report Date
    September 27, 2024
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    KRA
    PMA / PMN Number
    K093750
    Adverse Event
    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-RIST (UNKNOWN); PRODUCT TYPE: ; IMPLANT DATE N/A; EXPLANT DATE N/A PRODUCT ID 103-0608 (UNKNOWN); PRODUCT TYPE: ; IMPLANT DATE N/A; EXPLANT DATE N/A PRODUCT ID 105-5081-153 (UNKNOWN); PRODUCT TYPE: ; IMPLANT DATE N/A; EXPLANT DATE N/A PRODUCT ID UNK-NV-ECHELON (UNKNOWN); PRODUCT TYPE: ; IMPLANT DATE N/A; EXPLANT DATE N/A PRODUCT ID UNK-NV-APOLLO (UNKNOWN); PRODUCT TYPE: ; IMPLANT DATE N/A; EXPLANT DATE N/A PRODUCT ID UNK-NV-ONYX (UNKNOWN); PRODUCT TYPE: ; IMPLANT DATE N/A; EXPLANT DATE N/A PRODUCT ID UNK-NV-AXIUM (UNKNOWN); PRODUCT TYPE: ; IMPLANT DATE N/A; EXPLANT DATE N/A PRODUCT ID UNK-NV-RIST (UNKNOWN); PRODUCT TYPE: ; IMPLANT DATE N/A; EXPLANT DATE N/A PRODUCT ID 103-0608 (UNKNOWN); PRODUCT TYPE: ; IMPLANT DATE N/A; EXPLANT DATE N/A G2: CITATION: AUTHORS: FLOOD, R., NUNN, A. C., TALBOTT, J., COX, A., MINKS, D., WAREHAM, J., CROSSLEY, R., MALCOLM, G., PATEL, N. K., WIGFIELD, C., WILLIAMS, A., <(>&<)> MORTIMER, A.. INITIAL EXPERIENCE USING MIDDLE MENINGEAL ARTERY EMBOLISATION FOR PATIENTS WITH RECURRENT AND HIGH-RECURRENCE-RISK CHRONIC SUBDURAL HAEMATOMA. JOURNAL OF CLINICAL NEUROSCIENCE¿: OFFICIAL JOURNAL OF THE 2024. DOI :10.1016/J.JOCN.2024.05.022 A.2. THIS VALUE IS THE MEDIAN 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. 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.

    Additional Manufacturer Narrative · 0

    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

    FLOOD R, NUNN AC, TALBOTT J, ET AL. INITIAL EXPERIENCE USING MIDDLE MENINGEAL ARTERY EMBOLISATION FOR PATIENTS WITH RECURRENT AND HI GH-RECURRENCE-RISK CHRONIC SUBDURAL HAEMATOMA. JOURNAL OF CLINICAL NEUROSCIENCE: OFFICIAL JOURNAL OF THE NEUROSURGICAL SOCIETY OF AUSTRALASIA. 2024; 125:126-131. DOI: 10.1016/J.JOCN.2024.05.022 LITERATURE WAS REVIEWED REGARDING 'INITIAL EXPERIENCE USING MIDDLE MENINGEAL ARTERY EMBOLIZATION FOR PATIENTS WITH RECURRENT AND HIG H-RECURRENCE-RISK CHRONIC SUBDURAL HEMATOMA(CSDH).' THIS WAS A MONOCENTRIC RETROSPECTIVE OBSERVATIONAL STUDY. THE TIME FRAME OF THIS STUDY WAS BETWEEN NOVEMBER 2019 AND MARCH 2022. A TOTAL OF 26 CSDHS WERE EMBOLIZED IN 20 PATIENTS DURING THE STUDY PERIOD. SIX PATIENTS WITH 9 DE-NOVO CSDH AND 14 PATIENTS WITH 17 RECURRENT CSDH WERE TREATED. MEDIAN AGE WAS 83 YEARS, RANGED FROM 51-89 YEARS AND 19 OF THE PATIENTS WERE MALE. THE FOLLOWING MEDTRONIC DEVICES WERE USED: RIST, MIRAGE GUIDEWIRE, REBAR 18 MICROCATHETER, REBAR 27 MICROCATHETER, ECHELON 14 MICROCATHETER, APOLLO MICROCATHETER, ONYX 18 AND AXIUM AND AXIUM PRIME COILS DEATHS OCCURRED IN THE STUDY POPULATION. ONE PATIENT DIED WITHIN 6 MONTHS OF THE PROCEDURE, BUT THIS PATIENT HAD PRESENTED WITH A TERMINAL BASILAR ARTERY OCCLUSION IN ADDITION TO A RECURRENT SUBDURAL HEMATOMA AND THE PATIENT SUFFERED PNEUMONIA-ASSOCIATED RESPIRATORY FAILURE. AMONG PATIENT ADVERSE EVENTS INCLUDED: -ONE PATIENT EXPERIENCED SYMPTOMATIC WORSENING, SPECIFICALLY DETERIORATING UNILATERAL LEG WEAKNESS, 12 HOURS AFTER BILATERAL EMBOLIZ ATION USING PVA PARTICLES. THE SYMPTOMS SETTLED FOLLOWING UNILATERAL SURGICAL DRAINAGE WITH NO RESIDUUM IDENTIFIED AT IMAGING FOLLOW-UP AND EXCELLENT CLINICAL OUTCOME. -ONE PATIENT HAD A PERSISTENT STABLE COLLECTION AFTER EMBOLIZATION AND BURR HOLE DRAINAGE BUT WITH NO NEW SYMPTOMS AND WAS MANAGED C ONSERVATIVELY. -TWO PATIENTS (10 %) WITH RECURRENT CSDH REQUIRED FURTHER SURGICAL TREATMENT FOR PERSISTENT SYMPTOMATIC COLLECTIONS (BILATERAL CRANIOTOMY IN ONE PATIENT AND UNILATERAL CRANIOTOMY AND REPEAT MMAE IN A SECOND PATIENT). BOTH WERE LARGE RECURRENT SUBDURAL HEMATOMAS WITH A SMALLER ASSOCIATED CONTRALATERAL COLLECTION. IN EACH CASE THE ANGIOGRAPHIC IMAGING DEMONSTRATED THAT EMBOLIZATION WAS INCOMPLETE WITH A POSTERIOR MMA BRANCH PERSISTING ON COMPLETION ANGIOGRAPHY THERE WAS NO PROCEDURAL MORTALITY OR ACCESS SITE OR THROMBO-EMBOLIC COMPLICATIONS. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1709755 REBAR CATHETER, CONTINUOUS FLUSH KRA MICRO THERAPEUTICS, INC. DBA EV3 105-5082-130 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Male Death SEE H11...