BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOBO VASCULAR OCCLUDER

    MDR report key: 17376052 · Received July 24, 2023

    Report

    Report Number
    3016444913-2023-00001
    Event Type
    Injury
    Date Received
    July 24, 2023
    Date of Event
    June 22, 2023
    Report Date
    August 29, 2023
    Manufacturer
    OKAMI MEDICAL INC.
    Product Code
    KRD
    UDI-DI
    00850008222030
    PMA / PMN Number
    K220383
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ANGIOGRAPHIC IMAGES WERE SENT TO THE MANUFACTURER AND EVALUATED. BASED ON THE IMAGE AND DIMENSIONAL ANALYSIS, IT WAS DETERMINED THAT THE LOBO-7 DEVICE WAS PLACED IN A VESSEL LARGER THAN INDICATED FOR USE. THE INVESTIGATION CONCLUDED THAT THE IMPLANT MIGRATION WAS ATTRIBUTED TO INADVERTENT USE ERROR AND THERE IS NO EVIDENCE TO INDICATE THE PRESENCE OF A POTENTIAL QUALITY ISSUE WITH RESPECT TO MANUFACTURING, DESIGN, OR LABELING. REFERENCE #: (B)(4).

    Additional Manufacturer Narrative · 0

    THE LOBO-7 DEVICE REMAINS IMPLANTED IN THE PATIENT, REMAINS STABLE, AND IS NOT AVAILABLE FOR EVALUATION. THE DEVICE IDENTIFIERS WERE PROVIDED AND THE LOT HISTORY RECORDS WERE REVIEWED; THERE WERE NO DEVIATIONS OR NONCONFORMANCES RELEVANT TO THE REPORTABLE EVENT. INTRAOPERATIVE IMAGES WERE SENT TO THE MANUFACTURER FOR EVALUATION AND THE INVESTIGATION IS UNDERWAY. THE FINDINGS WILL BE FILED IN A SUPPLEMENTAL REPORT. IMPLANT MIGRATION AND OCCLUSION OF UNINTENDED VESSEL ARE LISTED IN THE DEVICE LABELING AS POTENTIAL COMPLICATIONS / ADVERSE EVENTS. REFERENCE #: (B)(4).

    Description of Event or Problem · 0

    PATIENT WAS TREATED FOR A SPLENIC ARTERY ANEURYSM MEASURING 2.5 - 3 CM. A LOBO-7 DEVICE WAS DEPLOYED IN THE SPLENIC ARTERY DISTAL TO THE ANEURYSM AND MIGRATED INTO AN UPPER POLE BRANCH OF THE SPLENIC ARTERY. THE DEVICE COULD NOT BE RETRIEVED WITH A SNARE AND THE PHYSICIAN ELECTED TO LEAVE IT IN PLACE. THE ANEURYSM WAS SUCCESSFULLY TREATED WITH LOBO-9 AND EMBOLIC COILS. THE SPLEEN WAS PARTIALLY INFARCTED, BUT NO LONG-TERM EFFECTS TO SPLENIC FUNCTION ARE ANTICIPATED BY THE PHYSICIAN. PATIENT WAS DISCHARGED FOLLOWING THE PROCEDURE WITH PAIN MEDICATION. THE PATIENT RETURNED TO THE HOSPITAL AND WAS ADMITTED FOR PAIN MANAGEMENT. DURING HOSPITALIZATION, THE PATIENT WAS TREATED FOR PAIN AND FLUID OVERLOAD (INCLUDING PULMONARY EDEMA), AND WAS SUBSEQUENTLY DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    771635 LOBO VASCULAR OCCLUDER VASCULAR EMBOLIZATION DEVICE KRD OKAMI MEDICAL INC. LOBO-7 23D0002 00850008222030

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Hospitalization| R CERENOVUS ENVOY 6 FR GUIDING CATHETER.