BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NV MICROCATHETER

    MDR report key: 10249122 · Received July 9, 2020

    Report

    Report Number
    2029214-2020-00676
    Event Type
    Injury
    Date Received
    July 9, 2020
    Date of Event
    July 23, 2019
    Report Date
    July 9, 2020
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    KRA
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    Y. HE, Y. DING, W. BAI, T. LI, F.K. HUI, W.-J. JIANG, AND J. XUE ¿SAFETY AND EFFICACY OF TRANSVENOUS EMBOLIZATION OF RUPTURED BRAIN ARTERIOVENOUS MALFORMATIONS AS A LAST RESORT: A PROSPECTIVE SINGLE-ARM STUDY¿ HTTPS://DOI.ORG/10.3174/AJNR.A6197 G4: PMA / 510(K) # MARATHON = K093750, ECHELON CATHETER = K093750, APOLLO CATHETER = P030004/S006 THE CATHETER HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, PRODUCT ANALYSIS CANNOT BE PERFORMED. THE DEVICE WAS NOT RETURNED; THEREFORE, THE REPORTED EVENT COULD NOT BE CONFIRMED. THE CAUSE OF THE EVENT CANNOT BE CONCLUSIVELY DETERMINED FROM THE PROVIDED INFORMATION. MDRS RELATED TO THIS EVENT: 2029214-2020-00674, 2029214-2020-00675, 2029214-2020-00677. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    Y. HE, Y. DING, W. BAI, T. LI, F.K. HUI, W.-J. JIANG, AND J. XUE ¿SAFETY AND EFFICACY OF TRANSVENOUS EMBOLIZATION OF RUPTURED BRAIN ARTERIOVENOUS MALFORMATIONS AS A LAST RESORT: A PROSPECTIVE SINGLE-ARM STUDY¿ HTTPS://DOI.ORG/10.3174/AJNR.A6197 MEDTRONIC RECEIVED INFORMATION REGARDING ONYX THROUGH LITERATURE REVIEW. IMMEDIATELY AFTER THE PROCEDURES, COMPLETE OBLITERATION WAS ACHIEVED IN 16 CASES, WITH AN OBLITERATION RATE OF 84.2% IN THE 19 TECHNICALLY FEASIBLE CASES AND 76.2% IN ALL 21 CASES. FOLLOW-UP ANGIOGRAPHY WAS PERFORMED FROM 1 TO 15 MONTHS AFTER EMBOLIZATION. STABLE OBLITERATION WAS CONFIRMED IN 18 PATIENTS. NO RECURRENCE WAS NOTED. ONE AVM LOCATED IN THE PARIETAL LOBE AND BASAL GANGLIA SHOWED PROGRESSIVE OCCLUSION. THE PROCEDURES INCLUDED 1 OR 2 MICROCATHETERS (MARATHON, APOLLO, ECHELON, OR HEADWAY DUO) PLACED AS CLOSE AS POSSIBLE TO THE NIDUS OF THE AVMS. AT THE COMPLETION OF THE PROCEDURE, THE MICROCATHETER INJECTING ONYX WAS CUT AT THE LEVEL OF THE JUGULAR SHEATH. A SINGLE MICROCATHETER WAS USED IN 3 PATIENTS AND 2 MICROCATHETERS IN 16 PATIENTS. THE MICROCATHETERS FOR ONYX INJECTION WERE RETAINED IN ALL PATIENTS EXCEPT ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718583 NV MICROCATHETER CATHETER, CONTINUOUS FLUSH KRA MICRO THERAPEUTICS, INC. DBA EV3 UNKNOWN NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability