BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEPS

    MDR report key: 18113516 · Received November 10, 2023

    Report

    Report Number
    2021898-2023-00118
    Event Type
    Injury
    Date Received
    November 10, 2023
    Date of Event
    June 10, 2021
    Report Date
    November 10, 2023
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K042359
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A2. PLEASE NOTE THAT THIS AGE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE, AS THE ACTUAL AGE OF PATIENTS INVOLVED WAS NOT PROVIDED. A3. PLEASE NOTE THAT THIS IS THE GENDER OF THE MAJORITY OF PATIENTS REPORTED IN THE ARTICLE AS THE ACTUAL GENDERS OF PATIENTS INVOLVED WAS NOT PROVIDED. B3. PLEASE NOTE THAT THIS DATE IS BASED OFF THE DATE OF PUBLICATION OF THE ARTICLE AS THE ACTUAL EVENT DATE WAS NOT PROVIDED. 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

    EHSAN DOWLATI 1, KELSI CHESNEY, AUSTIN B. CARPENTER, MITCHELL ROCK, NIRALI PATEL, JEFFREY C. MAI, AI-HSI LIU, ROCCO A. ARMONDA, DANIEL R. FELBAUM. AWAKE TRANSRADIAL MIDDLE MENINGEAL ARTERY EMBOLIZATION AND TWIST DRILL CRANIOSTOMY FOR CHRONIC SUBDURAL HEMATOMAS IN THE ELDERLY: CASE SERIES AND TECHNICAL NOTE. JOURNAL OF NEUROSURGICAL SCIENCES 67 (2023). DOI: 10.23736/S0390-5616.21.05335-2 A B S T RAC T BACKGROUND: DUE TO PROHIBITIVE PERIOPERATIVE RISK FACTORS, OPTIMAL TREATMENT FOR CHRONIC SUBDURAL HEMATOMAS (CSDH) IN THE ELDERLY REMAINS UNCLEAR. MINIMALLY INVASIVE TECHNIQUES ARE A VIABLE OPTION AND INCLUDE BEDSIDE SUBDURAL EVACUATION PORT SYSTEM (SEPS), AS WELL AS PREVENTION OF RECURRENCE WITH MIDDLE MENINGEAL ARTERY (MMA) EMBOLIZATION. WE PRESENT A CASE SERIES OF ELDERLY PATIENTS UNDERGOING COMBINED TRANSRADIAL MMA EMBOLIZATION AND BED-SIDE CRANIOSTOMY AS PRIMARY TREATMENT FOR CSDH. METHODS: PATIENTS 70 YEARS AND OLDER FROM 2019 TO 2020 THAT UNDERWENT SINGLE SETTING, AWAKE TRANSRADIAL MMA EMBOLIZATION WITH CONCURRENT SEPS PLACEMENT UNDER LOCAL ANESTHESIA WERE INCLUDED. THOSE WITH PRIOR TREATMENTS, INTERVENTIONS PERFORMED UNDER GENERAL ANESTHESIA, OR WITH LESS THAN 60-DAY FOLLOW-UP WERE EXCLUDED. DESCRIPTIVE ANALYSES OF BASELINE CHARACTERISTICS, RADIOLOGIC PARAMETERS, COMORBIDITIES, AND OUTCOMEMEASURES WERE COMPLETED. RESULTS: TWENTY ELDERLY PATIENTS (MEAN AGE OF 81.0 YEARS) WITH MULTIPLE COMORBIDITIES UNDERWENT 28 MMA EMBOLIZATION+SEPS PROCEDURES AS PRIMARY TREATMENT FOR CSDH. MEAN CSDH THICKNESS WAS 1.8CM±0.6 CM WITH 7.3±3.9 MM MIDLINE SHIFT. ALL PATIENTS TOLERATED THE PROCEDURE WELL. 1/20 (5.0%) PATIENTS DIED WITHIN 30 DAYS OF THE PROCEDURE. A MAJORITY OF PATIENTS WERE DISCHARGED TO HOME (12/20; 60.0%). THERE WAS AN AVERAGE OF 3.6-MONTH FOLLOW-UP AND ONE PATIENT (5.0%) DEVELOPED RECURRENCE IN THE FOLLOW-UP PERIOD REQUIRING FURTHER INTERVENTION. CONCLUSIONS: IN SELECT ELDERLY PATIENTS WITH HIGH PERIOPERATIVE RISK FACTORS, PRIMARY TREATMENT OF CSDH USING AWAKE TRANSRADIAL MMA EMBOLIZATION+SEPS PLACEMENT IS A MINIMALLY INVASIVE, FEASIBLE, AND SAFE OPTION. FURTHER COMPARATIVE STUDIES ARE WARRANTED TO EVALUATE EFFICACY OF THE TREATMENT. REPORTED EVENTS: - COMPLICATIONS DURING HOSPITALIZATION INCLUDED NEW POST-PROCEDURE SEIZURES IN THREE PATIENTS (15.0%), PLUS SINGULAR CASES OF URINARY TRACT INFECTION, ACUTE KIDNEY INJURY, PNEUMONIA, AND DEEP VENOUS THROMBOSIS (DVT) (5.0%). THE PATIENT WITH A POSTPROCEDURE DVT WAS MANAGED WITH A LOW-DOSE HEPARIN DRIP THAT WAS CONVERTED TO WARFARIN WITHOUT RECURRENT INTRACRANIAL BLEEDING. SEE ATTACHED LITERATURE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2080166 SEPS SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY 11-0401-CAL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male Other