BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALPHAVAC

    MDR report key: 14454360 · Received May 20, 2022

    Report

    Report Number
    1319211-2022-00022
    Event Type
    Injury
    Date Received
    May 20, 2022
    Date of Event
    May 3, 2022
    Report Date
    May 25, 2022
    Manufacturer
    ANGIODYNAMICS
    Product Code
    QEZ
    UDI-DI
    H787253020
    PMA / PMN Number
    K211081
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. THE RESULTS OF THE INVESTIGATION WILL BE SENT VIA A FOLLOW UP MEDWATCH. REFERENCE (B)(4).

    Additional Manufacturer Narrative · 0

    AS THE REPORTED DEVICE WAS NOT RETURNED, ANGIODYNAMICS IS UNABLE TO PERFORM A DEVICE EVALUATION. THE PRODUCT WAS NOT RETURNED FOR EVALUATION SINCE THERE WAS NO REPORT OF ALPHAVAC MALFUNCTION DURING THE PROCEDURE; JUST PATIENT SERIOUS ADVERSE EVENT (STROKE). THE CUSTOMER'S REPORTED COMPLAINT DESCRIPTION CANNOT BE CONFIRMED DUE TO THE NATURE OF THIS PATIENT SERIOUS ADVERSE EVENT; THERE WERE NO REPORTS OF ALPHAVAC MMA GEN 3 DEVICE MALFUNCTION DURING THE PROCEDURE. NO SAMPLE WAS RETURNED FOR EVALUATION. IT WAS CONCLUDED THAT THE ALPHAVAC DEVICE WAS UNRELATED TO THE PATIENT'S STROKE (DISTAL EMBOLIZATION OF THROMBUS); I.E. THIS WAS JUST AN ANTICIPATED PROCEDURAL COMPLICATION. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED FOR THE INDICATED LOTS FOR ANY DEVIATIONS RELATED TO THE REPORTED FAILURE MODE OF THE COMPLAINT. THE REVIEW CONFIRMS THAT THE LOTS MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS; I.E. NO NCR ASSOCIATED WITH REPORTED FAILURE MODE. LABELING REVIEW: DIRECTIONS FOR USE IS PROVIDED WITH THIS DEVICE AND CONTAINS THE FOLLOWING STATEMENTS: ADVERSE EVENTS THIS DEVICE, AS DO ALL EMBOLECTOMY SYSTEMS AND DEVICES, HAS POSSIBLE SIDE EFFECTS, WHICH INCLUDE, BUT ARE NOT LIMITED TO INFECTIONS, BLOOD LOSS, THROMBUS FORMATION, EMBOLIC EVENTS, VESSEL, VENTRICULAR OR VALVULAR DAMAGE AND COMPLICATIONS OF PERCUTANEOUS OR SURGICAL INSERTION TECHNIQUES. THESE MAY OCCUR IF THE DIRECTIONS FOR USE ARE NOT FOLLOWED. POSSIBLE COMPLICATIONS INCLUDE THOSE NORMALLY ASSOCIATED WITH LARGE BORE SURGICAL AND/OR PERCUTANEOUS VESSEL CATHETERIZATION/CANNULATION, ANTICOAGULATION, AND APPLICATION OF INTRAVASCULAR INTRODUCER SYSTEMS WHICH INCLUDE BUT ARE NOT LIMITED TO: · DEATH · DISTAL EMBOLIZATION OF THROMBUS · VASCULAR THROMBOSIS A REVIEW OF THE ANGIODYNAMICS COMPLAINT SYSTEM NOTED NO ADVERSE TRENDS FOR THIS COMPLAINT TYPE AND PRODUCT FAMILY. THIS TYPE OF COMPLAINT WILL CONTINUE TO BE MONITORED FOR TRENDS. REFERENCE (B)(4).

    Description of Event or Problem · 0

    THIS MEDWATCH IS NOT TO REPORT A DEVICE MALFUNCTION, BUT TO REPORT AN ADVERSE PATIENT EFFECT POST PROCEDURE. AN ANGIODYNAMICS TERRITORY MANAGER (TM) REPORTED VIA A PRODUCT EVALUATION SURVEY, A PATIENT ADVERSE EVENT OCCURRED AFTER TREATMENT WITH AN ALPHAVAC MULTIPURPOSE MECHANICAL ASPIRATION F18-85 CANNULA. THE PATIENT WAS TREATED FOR A LEFT ATRIAL THROMBUS, REMOVING APPROXIMATELY 95% OF THE THROMBOEMBOLI, AND NO ISSUES WERE NOTED DURING THE PROCEDURE. HOWEVER, APPROXIMATELY 2-3 HOURS AFTER THE PROCEDURE WAS COMPLETED, THE PATIENT SUFFERED A STROKE. AT THIS TIME THE PATIENT IS CURRENTLY STABLE AND IMPROVING. FOLLOW UP WITH THE TM DETERMINED THAT THE PHYSICIAN CONFIRMED THIS WAS NOT, IN ANYWAY, A RESULT OF PRODUCT MALFUNCTION BUT A COMPLICATION OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2578874 ALPHAVAC ALPHAVAC MULTIPURPOSE MECHANICAL ASPIRATION 25F/C20 QEZ ANGIODYNAMICS 25-302 420017 H787253020

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other