BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIOJET SOLENT OMNI

    MDR report key: 14734797 · Received June 17, 2022

    Report

    Report Number
    2134265-2022-06198
    Event Type
    Injury
    Date Received
    June 17, 2022
    Date of Event
    August 30, 2021
    Report Date
    June 17, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KRA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BSC AWARE DATE: USED EVENT NOTIFICATION DATE AS BSC AWARE DATE SINCE NONE WAS PROVIDED. DATE OF EVENT WAS APPROXIMATED BASED ON PUBLISH DATE OF ARTICLE. INITIAL REPORTER ADDRESS 1: (B)(6). XIAOFENG HAN, GUANGRUI LIU, TIEZHENG LI, AND XI GUO, BEIJING, CHINA. APPLICATION OF THE ANGIOJET ULTRA THROMBECTOMY DEVICE FOR THE PERCUTANEOUS MECHANICAL TREATMENT (PMT) OF ILIAC LIMB OCCLUSION AFTER ENDOVASCULAR ANEURYSM REPAIR (EVAR). ANN VASC SURG 2022 78: 161 THROUGH 169.

    Description of Event or Problem · 0

    REPORTED VIA JOURNAL ARTICLE THAT WITHIN THIS STUDY, IT WAS REPORTED THAT PATIENT COMPLICATIONS OCCURRED. A META ANALYSIS WAS PERFORMED TO INVESTIGATE THE SAFETY AND EFFICACY OF APPLYING THE ANGIOJET ULTRA THROMBECTOMY DEVICE IN TREATING ENDOGRAFT OCCLUSIONS IN THE ILIAC ARTERIES FOLLOWING ENDOVASCULAR ANEURYSM REPAIR (EVAR). THIS STUDY UTILIZED A RETROSPECTIVE ANALYSIS OF 452 PATIENTS WITH INFRARENAL ABDOMINAL AORTIC ANEURYSM (AAA). TWELVE OF THE PATIENTS EXPERIENCED ILIAC LIMB OCCLUSION DURING THEIR FOLLOW- UP PERIOD, AND THE 6F ANGIOJET SOLENT OMNI CATHETER WAS USED IN TANDEM WITH ILIAC ANGIOPLASTY TO TREAT THESE PATIENTS. TWO PATIENTS DEVELOPED GROSS HEMATURIA FOLLOWING SURGERY AND DISPLAYED HEMOGLOBINURIA, WHICH IN LARGE AMOUNTS, INCREASES KIDNEY LOADS AND LEADS TO ACUTE RENAL DAMAGE. THE SYMPTOMS OF ONE OF THE PATIENTS WAS ALLEVIATED A DAY LATER, WHILE THE OTHER HAD MILD TO MODERATE RENAL DYSFUNCTION, WITH CREATININE LEVEL BEING ELEVATED FROM 61.3 MICROMOLE PER LITER BEFORE SURGERY TO 124.1 MICROMOLE PER LITER FOLLOWING SURGERY. THE PATIENT WAS TREATED WITH INTRAVENOUS ADMINISTRATION OF 5% SODIUM BICARBONATE TO ALKALIZE THEIR URINE AND DIALYSIS, AND WAS DISCHARGED A WEEK LATER AFTER CREATININE LEVEL RETURNED TO NORMAL. THE REPEATED SUCTION FORCES DURING THE THROMBECTOMY PROCESS HAD CAUSED MECHANICAL DAMAGE TO THE RED BLOOD CELLS, WHICH LED TO INTRAVASCULAR HEMOLYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1682529 ANGIOJET SOLENT OMNI CATHETER, EMBOLECTOMY KRA BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention