BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NBCA LIQUID EMBOLIC KIT

    MDR report key: 6947132 · Received October 13, 2017

    Report

    Report Number
    1226348-2017-00170
    Event Type
    Injury
    Date Received
    October 13, 2017
    Date of Event
    January 1, 2017
    Report Date
    September 20, 2017
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    KGG
    PMA / PMN Number
    P990040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS SUBMITTED TO CORRECT THE MFR SITE CONTACT NAME AND EMAIL ADDRESS.

    Additional Manufacturer Narrative · 1

    (B)(6). THIS MDR IS FROM A LITERATURE ARTICLE AND DESCRIBES 2 PATIENTS. THERE WAS NO SPECIFIC PATIENT, DEVICE OR PROCEDURE INFORMATION PROVIDED. THIS SUBMISSION IS RELATED TO A LITERATURE ARTICLE DISCOVERED IN AN EFFORT TO SUPPORT THE CER SUBMISSION PROCESS, AS SUCH, THE ASSOCIATED TIME FRAME OF EVENT DATES INCLUDES BUT IS NOT LIMITED TO 20 YEARS. THESE ARTICLES ARE BEING REVIEWED ON A MONTHLY BASIS FOR SAFETY SIGNALS AND WILL BE FOLLOWED BY MONTHLY TRENDING ASSESSMENTS AS WELL AS PMS REVIEWS. ARTICLE ATTACHED TO THE MDR: YANG R.Y, TAN, K.T., BEECRIFT, J.R, ET AL, (2017). DIRECT SAC PUNCTURE VERSUS TRANSARTERIAL EMBOLIZATION OF TYPE II ENDOLEAKS: AN EVALUATION AND COMPARISON OF OUTCOMES, VASCULAR 2017, VOL. 25(3) 227¿233 DOI: 10.1177/1708538116663992. THREE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE AUTHOR WERE UNSUCCESSFUL. DATE OF EVENT, PRODUCT CODE, AND LOT NUMBER COULD NOT BE OBTAINED FROM THE AUTHOR. UDI: UNKNOWN PART NUMBER, ATTEMPTS TO OBTAIN PRODUCT PART NUMBER WERE UNSUCCESSFUL, UDI UNAVAILABLE. CONCLUSION: THE DEVICES WERE NOT AVAILABLE FOR ANALYSIS. IN ADDITION, THE LOT NUMBER COULD NOT BE OBTAINED; THEREFORE, A DHR REVIEW COULD NOT BE PERFORMED. PASSAGE OF EMBOLIC MATERIAL INTO NORMAL VESSELS ADJACENT TO THE LESION IS A KNOWN ADVERSE EVENT ASSOCIATED WITH EMBOLIZATION PROCEDURES AND IS LISTED IN THE INSTRUCTIONS FOR USE (IFU). THE TRUFILL N-BCA LIQUID EMBOLIC SYSTEM IS INDICATED FOR THE EMBOLIZATION OF CEREBRAL ARTERIOVENOUS MALFORMATIONS (AVMS) WHEN PRE-SURGICAL DEVASCULARIZATION IS DESIRED. THE IFU CAUTIONS THAT ¿HIGH BLOOD FLOW PRECLUDES SAFE INFUSION OF AN EMBOLIC AGENT¿. THERE IS NO CURRENT SAFETY SIGNAL IDENTIFIED RELATED TO THE REPORTED EVENT BASED ON REVIEW OF COMPLAINT HISTORY FOR THE DEVICE. SINCE THERE WAS NO EVIDENCE TO SUGGEST THE EVENT WAS RELATED TO A MANUFACTURING ISSUE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS IS AN INITIAL/FINAL MDR REPORT.

    Description of Event or Problem · 1

    IN THE LITERATURE ARTICLE ¿DIRECT SAC PUNCTURE VERSUS TRANSARTERIAL EMBOLIZATION OF TYPE II ENDOLEAKS: AN EVALUATION AND COMPARISON OF OUTCOMES¿ BY YANG R.Y, TAN, K.T., BEECRIFT, J.R, ET AL, PUBLISHED VASCULAR 2017, VOL. 25(3) 227¿233 DOI: 10.1177/1708538116663992, IT WAS REPORTED THAT TWO PATIENTS HAD UNINTENTIONAL GLUE EMBOLIZATIONS WITHOUT CONSEQUENCES DURING TREATMENT OF TYPE II ENDOLEAKS WITH TRUFILL NBCA EMBOLIZATION GLUE (CATALOG AND LOT NUMBERS NOT PROVIDED). PER THE ARTICLE, THE PURPOSE OF THE RETROSPECTIVE WAS TO DETERMINE THE OUTCOMES OF TYPE II ENDOLEAK EMBOLIZATION WITH ANEURYSM SAC OBLITERATION AND WHETHER THE APPROACH ¿ DIRECT SAC PUNCTURE OR TRANSARTERIAL ¿ AFFECTS OUTCOME. IT WAS REPORTED THAT TWO PATIENTS HAD SMALL NON-TARGET GLUE EMBOLIZATIONS WITH NO CONSEQUENCE. THERE WAS NO PATIENT, DEVICE OR PROCEDURE SPECIFIC DATA REPORTED FOR THESE TWO EVENTS. A REVIEW OF PATIENTS WHO UNDERWENT ENDOVASCULAR ANEURYSM REPAIRS AND SUBSEQUENT TYPE II ENDOOLEAKS EMBOLIZATION OVER 10 YEARS WAS PERFORMED. IN TOTAL, 23 PATIENTS (83% MALE, 17 % FEMALE) AND 35 3 EMBOLIZATION PROCEDURES WERE EXAMINED. THE MEDIAN AGE WAS 76 YEARS. THE EXACT EMBOLIZATION TECHNIQUE WAS INDIVIDUALIZED TO THE PATIENT¿S ANATOMY AND ENDOLEAK CONFIGURATION, AT THE DISCRETION OF THE RADIOLOGIST. EMBOLIZATION MATERIALS USED INCLUDED TRUFILL NCBA GLUE, PLATINUM MICROCOILS (MICRONESTER, COOK MEDICAL, (B)(4)), PARTICULATE EMBOLIC MATERIALS (EMBOSPHERE, MERIT MEDICAL, (B)(4)), AMPLATZERTM VASCULAR PLUG (ST. JUDE MEDICAL, (B)(4)), AND GELATIN SPONGE SLURRY. FOR GLUE EMBOLIZATIONS, NBCA GLUE AND LIPIODOL MIXTURE WERE USED (1:3¿1:4 GLUE:LIPIODOL RATIO, AT THE DISCRETION OF THE RADIOLOGIST BASED ON FLOW DYNAMICS IN THE ANEURYSM SAC).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727605 NBCA LIQUID EMBOLIC KIT TISSUE ADHESIVE FOR USE IN EMBOLIZATION OF BRAIN ARTERIOVENOUS MALFORMATIONS KGG CODMAN AND SHURTLEFF, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening