BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NBCA LIQUID EMBOLIC SYSTEM 2

    MDR report key: 5595848 · Received April 21, 2016

    Report

    Report Number
    1226348-2016-00063
    Event Type
    Injury
    Date Received
    April 21, 2016
    Date of Event
    October 30, 2015
    Report Date
    March 25, 2016
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    MFE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION COULD BE OBTAINED. SINCE THE LOT NUMBER WAS NOT PROVIDED, THE MANUFACTURING AND EXPIRATION DATE WAS UNKNOWN. UDI: PART AND LOT NUMBER UNKNOWN. UDI CANNOT BE PROVIDED. LITERATURE ARTICLE ATTACHED TO THIS MDR REPORT: HEIT, J.J., FAISAL, G.S., TELISCHAK, N.A., ET AL (2015). ¿HEADWAY DUO MICROCATHETER FOR CEREBRAL ARTERIOVENOUS MALFORMATION EMBOLIZATION WITH N-BCA¿, J NEUROINTERVENT SURG 2015;0:1-5. DOI:10.1136/NEURINTSUR-2015-012094. CONCLUSION: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. IN ADDITION, THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, A DHR REVIEW COULD NOT BE PERFORMED. HEMORRHAGE IS A KNOWN ADVERSE EVENT ASSOCIATED WITH EMBOLIZATION PROCEDURES AND IS LISTED IN THE INSTRUCTIONS FOR USE (IFU) AS SUCH. WITHOUT PROCEDURE FILMS OR ADDITIONAL INFORMATION, IT IS NOT POSSIBLE TO DETERMINE THE CAUSE OF THE HEMORRHAGE; HOWEVER, PATIENT FACTORS MAY HAVE CONTRIBUTED TO THE EVENT (8 PRIOR HEMORRHAGES FROM THE AVM). THERE WAS NO EVIDENCE TO SUGGEST THE EVENT WAS RELATED TO A MANUFACTURING ISSUE; THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS IS AN INITIAL/FINAL MDR REPORT.

    Description of Event or Problem · 1

    AS REPORTED IN A LITERATURE ARTICLE (HEIT, J.J., FAISAL, G.S., TELISCHAK, N.A., ET AL (2015). ¿HEADWAY DUO MICROCATHETER FOR CEREBRAL ARTERIOVENOUS MALFORMATION EMBOLIZATION WITH N-BCA¿, J NEUROINTERVENT SURG 2015;0:1-5. DOI:10.1136/NEURINTSUR-2015-012094) IT WAS REPORTED THAT PATIENT 5, WHO PRESENTED WITH A POSTERIOR FOSSA AVM, EXPERIENCED A HEMORRHAGE POST N-BCA (CATALOG/LOT NUMBERS UNKNOWN) INJECTION. THE OBJECTIVE OF THE STUDY WAS TO DESCRIBE THE EARLY EXPERIENCE WITH THE HEADWAY DUO MICROCATHETER FOR EMBOLIZATION OF CEREBRAL AVMS WITH N-BUTYL-CYANOACRYLATE (N-BCA). TEN CONSECUTIVE PATIENTS (7 WOMEN, 3 MEN), WITH A MEAN PATIENT AGE OF 25 YEARS WERE TREATED FROM (B)(6) 2014 TO (B)(6) 2015. A TOTAL OF 50 ARTERIAL PEDICLES WERE EMBOLIZED, AND MULTIPLE ARTERIAL PEDICLES WERE EMBOLIZED IN EACH PATIENT (RANGE 3 ¿ 9). ALL EMBOLIZATION PROCEDURES WERE TECHNICALLY SUCCESSFUL, AND AVMS WERE TREATED WITH SURGERY OR RADIATION AFTER EMBOLIZATION. THERE WAS ONE POST-PROCEDURAL HEMORRHAGE (OUT OF 32 SESSIONS; 3%) THAT WAS WELL TOLERATED BY THE PATIENT, AND NO OTHER COMPLICATIONS OCCURRED. THE PATIENT HAD PRESENTED WITH HEMORRHAGE SYMPTOMS PRIOR TO THE PROCEDURE. THE PATIENT HAD UNDERGONE 5 EMBOLIZATION SESSIONS WITH 9 ARTERIAL PEDICLES TREATED (POSTERIOR INFERIOR CEREBRAL ARTERY X 3 AND SUPERIOR CEREBELLAR ARTERY X 6). THE N-BCA DILUTION HAD BEEN 1:2.5. THE HEMORRHAGE OCCURRED 4 DAYS AFTER HER TREATMENT, AND SHE HAD 8 PRIOR HEMORRHAGES FROM HER AVM. THE AVM WAS TREATED WITH SURGERY AFTER EMBOLIZATION. DURING THE PROCEDURE, INTRAVENOUS HEPARIN WAS ADMINISTERED TO ACHIEVE AN ACTIVATED CLOTTING TIME OF 250-300 S. ACCORDING TO THE AUTHOR, GIVEN HOW UNSTABLE HER AVM WAS, HE WOULD NOT NECESSARILY EVOKE THE GLUE AS THE CAUSE, ESPECIALLY WITH A HEMORRHAGE 4 DAYS OUT. SHE DID FINE AND DID NOT REQUIRE ANY FURTHER TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249041 NBCA LIQUID EMBOLIC SYSTEM 2 TRUFILL N-BCA-2 GRAM KIT MFE CODMAN AND SHURTLEFF, INC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening