BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NBCA LIQUID EMBOLIC SYSTEM 2

    MDR report key: 5996123 · Received October 4, 2016

    Report

    Report Number
    1226348-2016-00145
    Event Type
    Injury
    Date Received
    October 4, 2016
    Date of Event
    August 1, 2016
    Report Date
    September 16, 2016
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    KGG
    PMA / PMN Number
    P990040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE ARTICLE ATTACHED: PICEL A.C., KOO S.L., ROBERTS A.C. (AUGUST 2016) ¿TRANSCATHETER ARTERIAL EMBOLIZATION WITH N-BUTYL CYANOACRYLATE FOR THE TREATMENT OF ACQUIRED UTERINE VASCULAR MALFORMATIONS¿. CARDIOVASCULAR AND INTERVENTIONAL RADIOLOGY. 39 (8) (PP 1170-1176). THE AUTHOR WAS NOT ABLE TO PROVIDE ANY ADDITIONAL INFORMATION, INCLUDING PRODUCT CODE AND CATALOG NUMBER AND DATE OF THE PROCEDURE. DEVICE MANUFACTURING AND EXPIRATION DATES ARE UNKNOWN SINCE LOT AND PRODUCT CODES COULD NOT BE PROVIDED. THIS IS (B)(4) ASSOCIATED WITH THIS LITERATURE ARTICLE WITH ASSOCIATED (B)(4). UDI: THE PRODUCT CODE AND LOT NUMBER WERE NOT AVAILABLE; THEREFORE UDI IS UNKNOWN. CONCLUSION: THE DEVICE WAS NOT AVAILABLE FOR ANALYSIS. IN ADDITION, THE LOT NUMBER COULD NOT BE PROVIDED; THEREFORE, A DHR REVIEW COULD NOT BE PERFORMED. FAILED ATTEMPT TO EMBOLIZE THE AVM IS A KNOWN ADVERSE EVENT ASSOCIATED WITH NBCA GLUE. THE TRUFILL SYSTEM IS USED UNDER FLUOROSCOPIC GUIDANCE TO OBSTRUCT OR REDUCE BLOOD FLOW TO CEREBRAL ARTERIOVENOUS MALFORMATIONS (AVMS) VIA SUPERSELECTIVE CATHETER DELIVERY. THE ROOT CAUSE OF THE EMBOLIZATION FAILURE COULD NOT BE DETERMINED; HOWEVER, PROCEDURAL OR PATIENT FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. 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

    IN THE LITERATURE ARTICLE "TRANSCATHETER ARTERIAL EMBOLIZATION WITH N-BUTYL CYANOACRYLATE FOR THE TREATMENT OF ACQUIRED UTERINE VASCULAR MALFORMATIONS" BY PICEL A.C.; KOO S.J.; ROBERTS A.C, PUBLISHED IN CARDIOVASCULAR AND INTERVENTIONAL RADIOLOGY. 39 (8) (PP 1170-1176), A PATIENT (PATIENT 4) EXPERIENCED PERSISTENT AVM ON ULTRASOUND 291 DAYS AFTER LEFT UTERINE ARTERY EMBOLIZATION WITH NBCA (3ML OF 1:2 AND 1:1.5 MIXTURE). THE CATALOG/LOT NUMBER OF THE NBCA WAS NOT PROVIDED IN THE ARTICLE. THE AVM WAS INITIALLY DISCOVERED VIA ROUTINE UNTRASOUND APPROXIMATELY 4 YEARS AFTER FIBROID RESECTION. NBCA WAS USED TO EMBOLIZE THE LEFT UTERINE ARTERY, BUT THE AVM WAS SEEN TO BE PERSISTENT ON ULTRASOUND. EIGHT MONTHS LATER, REPEAT TREATMENT WAS PROVIDED WITH BILATERAL UTERINE ARTERY EMBOLIZATION WITH NBCA (1ML OF 1:4 AND 3ML OF 1:9 MIXTURES). THE AVM WAS IMPROVED, BUT PERSISTENT. THE PATIENT HAD A NORMAL INTRA-UTERINE PREGNANCY APPROXIMATELY 2 YEARS AFTER TREATMENT. NO FURTHER PATIENT, PROCEDURE OR DEVICE INFORMATION WAS PROVIDED. THE PURPOSE OF THE STUDY WAS TO EVALUATE THE TECHNIQUE AND OUTCOMES OF TRANS-CATHETER ARTERIAL EMBOLIZATION (TAE) WITH N-BUTYL CYANOACRYLATE (NBCA) FOR THE TREATMENT OF ACQUIRED UTERINE ARTERIOVENOUS MALFORMATIONS (AVMS). EMBOLIZATION RESULTED IN ANGIOGRAPHIC STASIS OF FLOW IN ALL SEVEN PROCEDURES. THERE WERE NO MAJOR COMPLICATIONS. THREE OF THE FIVE WOMEN TREATED HAD PREGNANCIES AND DELIVERIES AFTER EMBOLIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648922 NBCA LIQUID EMBOLIC SYSTEM 2 TISSUE ADHESIVE FOR USE IN EMBOLIZATION OF BRAIN ARTERIOVENOUS MALFORMATIONS KGG CODMAN AND SHURTLEFF, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention