BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUFILL N-BCA-1 GRAM KIT

    MDR report key: 14143238 · Received April 19, 2022

    Report

    Report Number
    3008114965-2022-00300
    Event Type
    Injury
    Date Received
    April 19, 2022
    Date of Event
    February 22, 2022
    Report Date
    April 19, 2022
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    KGG
    UDI-DI
    10886704029151
    PMA / PMN Number
    P990040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INFORMATION REGARDING PATIENT WEIGHT, HEIGHT, MEDICAL HISTORY, RACE, AND ETHNICITY WAS NOT REPORTED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. COMPLAINT CONCLUSION: AS REPORTED VIA THE MEMBRANE STUDY, A 78-YEAR-OLD MALE (SUBJECT (B)(6)) WITH A HISTORY OF CARDIAC ARRHYTHMIA, CORONARY ARTERY DISEASE (CAD), DIABETES, HEAD INJURY WITHIN THE PAST 12 MONTHS, AND CONTROLLED HYPERTENSION UNDERWENT MIDDLE MENINGEAL ARTERY (MMA) EMBOLIZATION OF A LEFT FRONTAL CHRONIC SUBDURAL HEMATOMA (CSDH) ON (B)(6) 2022 AND EXPERIENCED A RIGHT POSTERIOR CEREBRAL ARTERY INFARCT ON (B)(6) 2022. COMPUTED TOMOGRAPHY (CT) SCAN OF THE BRAIN WITHOUT CONTRAST WAS PERFORMED AS DIAGNOSTIC TEST/EVALUATION. THE EVENT HAS NOT RESOLVED. PER THE PRINCIPAL INVESTIGATOR (PI), THE EVENT WAS MODERATE IN SEVERITY AND POSSIBLY RELATED TO THE STUDY DEVICE AND STUDY PROCEDURE (I.E., MMA EMBOLIZATION). THE EVENT WAS CONSIDERED SERIOUS BY THE PI AS THE EVENT REQUIRED PROLONGED HOSPITALIZATION. THE PATIENT WAS DISCHARGED TO A REHABILITATION CENTER ON (B)(6) 2022 WITH MODIFIED RANKIN SCALE (MRS) SCORE OF 4. THE PATIENT WAS RANDOMIZED INTO THE NON-SURGICAL MEDICAL MANAGEMENT (NSMM) AND MMA EMBOLIZATION COHORT OF THE STUDY. HIS BASELINE MARKWALDER GRADING SCALE (MGS) SCORE WAS 1 AND MODIFIED RANKIN SCALE (MRS) SCORE WAS 2. THE CSDH THICKNESS WAS 17MM AND VOLUME 58.4ML. THE MMA EMBOLIZATION STUDY PROCEDURE WAS PERFORMED ON (B)(6) 2022 VIA RIGHT RADIAL ACCESS. TRUFILL N-BCA 1X1 GRAM GLUE (631500/JR4806) (4:1 OIL: N-BCA RATIO) WAS DELIVERED VIA A HEADWAY DUO MICROCATHETER (MICROVENTION). NO VASOSPASM NOR NON-TARGET EMBOLIZATION OCCURRED DURING THE PROCEDURE. IN THE OPINION OF THE TREATING PHYSICIAN, THE MMA EMBOLIZATION WAS SUCCESSFUL. THE DEVICE REMAINS IMPLANTED, THEREFORE, NO FURTHER INVESTIGATION CAN BE PERFORMED. A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED FOR THE FINISHED DEVICE JR4806 NUMBER, AND NO NON-CONFORMANCES RELATED TO THE MALFUNCTION WERE IDENTIFIED. CEREBRAL INFARCTION IS A KNOWN POTENTIAL COMPLICATIONS ASSOCIATED WITH THIS TYPE OF EMBOLIZATION PROCEDURES AND IS LISTED IN THE TRUFILL N-BCA INSTRUCTIONS FOR USE (IFU) AS SUCH. WITH THE AMOUNT OF INFORMATION AVAILABLE, IT IS NOT POSSIBLE TO DRAW A CONCLUSION BETWEEN THE DEVICE AND THE REPORTED EVENT. HOWEVER, THERE ARE PATIENT, PROCEDURAL, AND PHARMACOLOGICAL FACTORS THAT MAY HAVE CONTRIBUTED TO THE CEREBRAL INFARCTION RATHER THAN THE DESIGN OR MANUFACTURE OF THE DEVICE. THERE IS NO EVIDENCE TO SUGGEST A DEVICE MALFUNCTION OR QUALITY ISSUE. CEREBRAL INFARCTION IS A CONDITION WHICH MAY REQUIRE MEDICAL AND/OR INVASIVE INTERVENTION AND HOSPITALIZATION TO PREVENT PERMANENT IMPAIRMENT. FURTHERMORE, THE PI ASSESSED THE EVENT AS POSSIBLY RELATED TO THE STUDY DEVICE. THUS, THE EVENT IS CONSIDERED SERIOUS , THE FILE WILL BE RE-REVIEWED IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE. AS PART OF THE CERENOVUS QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. AS PART OF THE POST MARKET SURVEILLANCE PROGRAM, INFORMATION FROM THIS COMPLAINT IS TRENDED TO IDENTIFY STATISTICAL SIGNALS FOR CONSIDERATION OF FURTHER CORRECTION ACTION. SINCE THERE WAS NO EVIDENCE TO SUGGEST THE EVENT WAS RELATED TO A MANUFACTURING OR DESIGN ISSUE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 0

    AS REPORTED VIA THE MEMBRANE STUDY, A 78-YEAR-OLD MALE (SUBJECT (B)(6)) WITH A HISTORY OF CARDIAC ARRHYTHMIA, CORONARY ARTERY DISEASE (CAD), DIABETES, HEAD INJURY WITHIN THE PAST 12 MONTHS, AND CONTROLLED HYPERTENSION UNDERWENT MIDDLE MENINGEAL ARTERY (MMA) EMBOLIZATION OF A LEFT FRONTAL CHRONIC SUBDURAL HEMATOMA (CSDH) ON (B)(6) 2022 AND EXPERIENCED A RIGHT POSTERIOR CEREBRAL ARTERY INFARCT ON (B)(6) 2022. COMPUTED TOMOGRAPHY (CT) SCAN OF THE BRAIN WITHOUT CONTRAST WAS PERFORMED AS DIAGNOSTIC TEST/EVALUATION. THE EVENT HAS NOT RESOLVED. PER THE PRINCIPAL INVESTIGATOR (PI), THE EVENT WAS MODERATE IN SEVERITY AND POSSIBLY RELATED TO THE STUDY DEVICE AND STUDY PROCEDURE (I.E., MMA EMBOLIZATION). THE EVENT WAS CONSIDERED SERIOUS BY THE PI AS THE EVENT REQUIRED PROLONGED HOSPITALIZATION. THE PATIENT WAS DISCHARGED TO A REHABILITATION CENTER ON (B)(6) 2022 WITH MODIFIED RANKIN SCALE (MRS) SCORE OF 4. THE PATIENT WAS RANDOMIZED INTO THE NON-SURGICAL MEDICAL MANAGEMENT (NSMM) AND MMA EMBOLIZATION COHORT OF THE STUDY. HIS BASELINE MARKWALDER GRADING SCALE (MGS) SCORE WAS 1 AND MODIFIED RANKIN SCALE (MRS) SCORE WAS 2. THE CSDH THICKNESS WAS 17MM AND VOLUME 58.4ML. THE MMA EMBOLIZATION STUDY PROCEDURE WAS PERFORMED ON (B)(6) 2022 VIA RIGHT RADIAL ACCESS. TRUFILL N-BCA 1X1 GRAM GLUE (631500/JR4806) (4:1 OIL: N-BCA RATIO) WAS DELIVERED VIA A HEADWAY DUO MICROCATHETER (MICROVENTION). NO VASOSPASM NOR NON-TARGET EMBOLIZATION OCCURRED DURING THE PROCEDURE. IN THE OPINION OF THE TREATING PHYSICIAN, THE MMA EMBOLIZATION WAS SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2619742 TRUFILL N-BCA-1 GRAM KIT TISSUE ADHESIVE FOR USE IN EMBOLIZATION OF BRAIN ARTERIOVENOUS MALFORMATIONS KGG MEDOS INTERNATIONAL SARL 631-500 JR4806 10886704029151

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Unknown Hospitalization HEADWAY DUO MICROCATHETER (MICROVENTION)