BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NBCA LIQUID EMBOLIC SYSTEM 2

    MDR report key: 4743974 · Received May 1, 2015

    Report

    Report Number
    1058196-2015-00094
    Event Type
    Injury
    Date Received
    May 1, 2015
    Date of Event
    November 14, 2013
    Report Date
    April 10, 2015
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    MFE
    PMA / PMN Number
    P990040
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBER UNKNOWN, ALL 3 ATTEMPTS TO OBTAIN NUMBER WERE UNSUCCESSFUL - (B)(4). NO STERILE LOT NUMBER INFORMATION WAS AVAILABLE THUS NO DHR COULD BE PERFORMED. GLUE EMBOLIZATION IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH USE OF THE TRUFILL LIQUID EMBOLIC SYSTEM AND IS LISTED IN THE IFU AS SUCH. THE TRUFILL SYSTEM IS USED UNDER FLUOROSCOPIC GUIDANCE TO OBSTRUCT OR REDUCE BLOOD FLOW TO CEREBRAL ARTERIOVENOUS MALFORMATIONS (AVMS) VIA SUPER SELECTIVE CATHETER DELIVERY. UPON CONTACT WITH BODY FLUIDS OR TISSUE, THE MIXTURE POLYMERIZES INTO A SOLID MATERIAL. ALL PRODUCTS ARE 100% INSPECTED PRIOR TO LEAVING THE MANUFACTURING FACILITY AND THERE IS NO EVIDENCE OF A MANUFACTURING RELATED ISSUE. THE SYSTEM IS INDICATED FOR THE EMBOLIZATION OF CEREBRAL ARTERIOVENOUS MALFORMATIONS (AVMS) WHEN PRE-SURGICAL DEVASCULARIZATION IS DESIRED. THE IFU STATES: USE OF THE TRUFILL N-BCA LIQUID EMBOLIC SYSTEM IS CONTRAINDICATED WHEN ANY OF THE FOLLOWING CONDITIONS EXIST: OPTIMAL CATHETER PLACEMENT IS NOT POSSIBLE; A PREVIOUS HISTORY OF REACTIONS TO CYANOACRYLATES EXISTS; A PREVIOUS HISTORY OF HYPERSENSITIVITY TO ETHIODIZED OIL EXISTS; A PREVIOUS HISTORY OF REACTIONS TO IODINE EXISTS; PROVOCATIVE TESTING INDICATES INTOLERANCE TO THE OCCLUSION PROCEDURE; VASOSPASM STOPS BLOOD FLOW; HIGH BLOOD FLOW PRECLUDES SAFE INFUSION OF AN EMBOLIC AGENT. REVIEW OF THE INFORMATION SUGGESTS THAT TARGET SITE CHARACTERISTICS AND CHOICE OF TREATMENT METHOD MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS IN THIS OFF LABEL USE OF THE NBCA PRODUCT.

    Description of Event or Problem · 1

    IT WAS REPORTED IN THE LITERATURE ARTICLE ¿THE USE OF ADENOSINE IN THE TREATMENT OF A HIGH FLOW VEIN OF GALEN MALFORMATION IN AN ADULT¿, BY TSIMPAS, A; CHALOUHI, N; HALEVY, J; TJOUMAKARIS, S; GONZALEZ, LF; MONTIETH, S; DUMONT, A; ROSENWASSER, R AND JABBOUR, P; IN THE JOURNAL OF CLINICAL NEUROSCIENCE 21 (2014) 1259-1261, THAT AFTER THE TREATMENT OF A HIGH-FLOW VEIN OF GALEN ANEURYSMAL MALFORMATIONS (VGAM) WITH NBCA GLUE, THE GLUE EMBOLIZED AND THE PATIENT SUFFERED ISCHEMIC STROKES. THIS CASE INVOLVED A (B)(6) MALE WITH A HISTORY OF NON-SPECIFIC HEADACHES AND A VAGM. THIS ARTICLE REVIEWED THE EFFICACY OF THE USE OF ADENOSINE TO DECREASE THE BLOOD FLOW THROUGH THE MALFORMATION. MRI REVEALED A MURAL LESION WITH RAPID ARTERIOVENOUS (AV) SHUNTING WITH MULTIPLE ARTERIAL FEEDERS, WHICH ORIGINATED FROM ANTERIOR (ACA), MIDDLE AND POSTERIOR CEREBRAL ARTERIES BILATERALLY, AS WELL AS ANTERIOR AND POSTERIOR CHOROIDAL BRANCHES AND TERMINATED AT A LARGELY DILATED VENOUS POUCH THAT DRAINED INTO A FALCINE SINUS. A MICROINJECTION WITH CONTRAST MADE OBVIOUS THAT EMBOLIZATION OF THE ARTERIAL FEEDER WITHOUT SLOWING DOWN THE AVSHUNT WOULD BE EXTREMELY DANGEROUS. A 70% MIXTURE OF N-BUTYL CYANOACRYLATE (TRUFILL N-BCA, CODMAN NEUROVASCULAR) IN ETHIODIZED OIL WAS CHOSEN DUE TO ITS ADHESIVE PROPERTIES AND RAPID POLYMERIZATION. A NICARDIPINE INFUSION DROPPED THE MEAN ARTERIAL PRESSURE TO 40. A REPEAT RIGHT ICA ANGIOGRAM DID NOT DEMONSTRATE ANY SIGNIFICANT SLOWING OF THE AV SHUNT. A SLOW INJECTION OF N-BCA WAS ATTEMPTED, BUT IT WAS RAPIDLY SHUNTED TO THE VENOUS SIDE. AN ATTEMPT TO FURTHER DECREASE THE FLOW WITH MULTIPLE COILS THROUGH THE VENOUS SIDE WITHOUT DETACHING THEM WAS UNSUCCESSFUL, SINCE THE STRONG AV SHUNT PUSHED THEM OUT OF THE VENOUS POUCH AND INTO THE TORCULA. ADENOSINE WAS USED TO HELP SLOW THE SHUNTING OF BLOOD PRIOR TO ENDOVASCULAR TREATMENT OF THE VAGM. A TEST DOSE OF 21 MG ADENOSINE (0.3 MG/KG) PRODUCED ONLY A 3¿4 SECOND FLOW ARREST. A SUBSEQUENT DOSE OF 39 MG (0.55 MG/KG) PRODUCED AN APPROXIMATELY 10 SECOND LONG NEAR ASYSTOLE, AND THE N-BCA WAS INJECTED INTO THE RIGHT ACA FEEDER. A REPEAT ANGIOGRAPHIC RUN SHOWED SIGNIFICANT SLOWING OF THE AV SHUNT WITHOUT SUBSTANTIAL OBSTRUCTION OF THE VENOUS OUTFLOW. THE PATIENT WAS THEN EXTUBATED AND WAS TRANSFERRED TO THE INTENSIVE CARE UNIT. HE WAS NEUROLOGICALLY INTACT. DURING THE FIRST POSTOPERATIVE NIGHT THE PATIENT BECAME PROGRESSIVELY LETHARGIC AND STOPPED FOLLOWING COMMANDS. A CT SCAN OF THE BRAIN REVEALED CLOTTING OF THE VENOUS POUCH AND FORMATION OF A RIGHT BASAL GANGLIA AND A LEFT FRONTAL VENOUS INFARCTION WITH EARLY HEMORRHAGIC TRANSFORMATION. EMBOLIC MATERIAL WAS SEEN INSIDE THE FALCINE SINUS AND THE TORCULA, CAUSING AT LEAST PARTIAL OUTFLOW OBSTRUCTION. THE PATIENT WAS EVENTUALLY DISCHARGED TO A REHABILITATION FACILITY AND HIS CLINICAL CONDITION PROGRESSIVELY IMPROVED TO THE POINT WHERE HE WAS NEUROLOGICALLY INTACT AT HIS 6 MONTH CLINICAL FOLLOW-UP. FOLLOW-UP ANGIOGRAPHY ALSO DEMONSTRATED 100% OCCLUSION OF THE LESION. DESPITE THIS COMPLICATION, AN EXCELLENT CLINICAL AND ANGIOGRAPHIC OUTCOME WAS ACHIEVED IN THIS PATIENT. THE GLUE REMAINS IMPLANTED THUS UNAVAILABLE FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288861 NBCA LIQUID EMBOLIC SYSTEM 2 CNV_NBCA (MFE) MFE CODMAN AND SHURTLEFF, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R| S