BEUDAMED
    FDA Adverse Event Death Summary report: N

    ALPHAVAC

    MDR report key: 19300730 · Received May 13, 2024

    Report

    Report Number
    1319211-2024-00053
    Event Type
    Death
    Date Received
    May 13, 2024
    Date of Event
    April 25, 2024
    Report Date
    August 26, 2024
    Manufacturer
    ANGIODYNAMICS, INC.
    Product Code
    QEZ
    UDI-DI
    H787253020
    PMA / PMN Number
    K240397
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER'S REPORTED COMPLAINT DESCRIPTION OF PATIENT EXPIRATION FOLLOWING A PULMONARY EMBOLISM (PE) REMOVAL PROCEDURE CANNOT BE CONFIRMED GIVEN THE PATIENT CENTRIC NATURE OF THIS SERIOUS ADVERSE EVENT (SAE). THERE WERE NO REPORTS OF ALPHAVAC DEVICE MALFUNCTION DURING THE PROCEDURE; THEREFORE, THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE PHYSICIAN FEEDBACK THAT CANNULA TIP COLLAPSED (MOMENTARILY) DURING ASPIRATION PRESSURE IS NOT UNUSUAL FOR THIS DEVICE AND IS NOT A DEVICE MALFUNCTION. 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 (10903657) ARE PROVIDED WITH THIS DEVICE AND CONTAIN THE FOLLOWING STATEMENTS: INDICATIONS FOR USE: THE CANNULA IS INDICATED FOR: THE NON-SURGICAL REMOVAL OF THROMBI OR EMBOLI FROM THE VENOUS VASCULATURE. ASPIRATION OF CONTRAST MEDIA AND OTHER FLUIDS FROM THE VENOUS VASCULATURE. THE CANNULA IS INTENDED FOR USE IN THE VENOUS SYSTEM. DIRECTIONS FOR USE AND MANUALS FOR THE ALPHAVAC SYSTEM AND ALL RELATED ACCESSORIES SHOULD BE READ PRIOR TO USE AND DEVICES USED AS INDICATED. AS WITH ALL MEDICAL DEVICES, THIS DEVICE AND ANCILLARY EQUIPMENT ARE TO BE USED BY TRAINED PHYSICIANS ONLY. SPECIFICALLY, THIS DEVICE IS TO BE USED ONLY BY MEDICAL PERSONNEL EXPERIENCED WITH USING SURGICAL AND/OR PERCUTANEOUS (SELDINGER) VASCULAR ACCESS TECHNIQUES AS WELL AS PHYSICIANS TRAINED AND EXPERIENCED IN PERCUTANEOUS, INTRAVASCULAR, DIAGNOSTIC AND INTERVENTIONAL TECHNIQUES REQUIRING FLUOROSCOPIC OR IMAGE GUIDANCE AND VISUALIZATION. 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: DISTAL EMBOLIZATION OF THROMBUS, PULMONARY EMBOLISM, CARDIAC ARREST, DEATH. 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).

    Additional Manufacturer Narrative · 0

    THE REPORTED DEVICE WILL NOT BE RETURNED TO THE MANUFACTURER AS IT HAS BEEN DISPOSED OF AN INVESTIGATION INTO THE ROOT CAUSE FOR EVENT IS CURRENTLY IN PROGRESS. THE RESULTS OF THE INVESTIGATION WILL BE SENT VIA A FOLLOW UP MEDWATCH. REFERENCE (B)(4).

    Description of Event or Problem · 0

    AN ANGIODYNAMICS SALES DIRECTOR REPORTED A PATIENT DEATH, OCCURRING A FEW HOURS AFTER AN ALPHAVAC PROCEDURE, WITH AN ALPHAVAC MULTIPURPOSE MECHANICAL ASPIRATOR F18 C85. THE PROCEDURE WAS PERFORMED IN ALIGNMENT WITH THE DIRECTIONS FOR USE (DFU) AND ALTHOUGH THIS WAS THE PHYSICIAN'S FIRST ALPHAVAC CASE, HE IS AN EXPERIENCED PENUMBRA AND INARI USER. NO ADJUNCT DEVICES WERE UTILIZED DURING THE PROCEDURE. ACCORDING TO THE PHYSICIAN, THE PATIENT WAS IN CRITICAL CONDITION, WITH MULTIPLE PULMONARY EMBOLI, AND THEIR DEATH WAS UNRELATED TO ANY ANGIODYNAMICS DEVICE. IT WAS NOTED; HOWEVER, THAT THE FUNNEL PORTION OF THE DEVICE COLLAPSES EASILY UNDER NEGATIVE PRESSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409706 ALPHAVAC ASPIRATION THROMBECTOMY CATHETER QEZ ANGIODYNAMICS, INC. H787253020

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Death