BEUDAMED
    FDA Adverse Event Death Summary report: N

    ANGIODYNAMICS / ANGIOVAC

    MDR report key: 8367602 · Received February 25, 2019

    Report

    Report Number
    1317056-2019-00042
    Event Type
    Death
    Date Received
    February 25, 2019
    Date of Event
    February 16, 2019
    Report Date
    February 25, 2019
    Manufacturer
    ANGIODYNAMICS
    Product Code
    DWF
    UDI-DI
    H965251860
    PMA / PMN Number
    K142593
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO LOT NUMBER WAS REPORTED, A SHIP HISTORY REPORT (SHR) WAS GENERATED FOR ITEM NUMBER (H965251860) IN ORDER TO DETERMINE THE LAST THREE LOTS SHIPPED TO THE REPORTING HOSPITAL IN THE SIX MONTHS PRIOR TO THE PROCEDURE DATE. THE THREE LOTS OBTAINED THROUGH THE SHR WERE (5398467, 5378568 AND 5412623). THE DEVICE HISTORY RECORDS FOR THE LOTS OBTAINED THROUGH THE SHIP HISTORY REPORT WERE REVIEWED. THE REVIEW CONFIRMS THAT THE LOTS MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE RECENT ANGIODYNAMICS COMPLAINT REPORT WAS REVIEWED FOR THE ANGIOVAC PRODUCT FAMILY AND THE FAILURE MODE "PATIENT INJURY/DEATH." NO ADVERSE TREND WAS IDENTIFIED. NO SAMPLE WAS RECEIVED FOR EVALUATION (DEVICE DISCARDED AT HOSPITAL). THE EVENT REPORT STATES THAT EVENT REPORT STATES THAT, "THE PATIENT WAS STABLE DURING THE ENTIRE PROCEDURE AND IMMEDIATELY AFTER, BUT CODED UPON ARRIVAL IN THE CVICU. ATTEMPTS TO REVIVE HIM WERE UNSUCCESSFUL. THE PATIENT DEATH IS NOT RELATED TO THE PRODUCT." AS STATED IN THE DIRECTIONS FOR USE SUPPLIED WITH THE ANGIOVAC, REGARDING ADVERSE EVENTS: "THIS DEVICE, AS DO ALL EXTRACORPOREAL BLOOD VESSEL 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 INSTRUCTIONS FOR USE ARE NOT FOLLOWED. POSSIBLE COMPLICATIONS INCLUDE THOSE NORMALLY ASSOCIATED WITH LARGE BORE SURGICAL AND/OR PERCUTANEOUS VESSEL CATHETERIZATION/CANNULATION, ANTICOAGULATION, EXTRACORPOREAL CIRCULATION AND APPLICATION OF INTRAVASCULAR INTRODUCER SYSTEMS WHICH INCLUDE BUT ARE NOT LIMITED TO: DEATH; PULMONARY EMBOLISM." ((B)(4)).

    Description of Event or Problem · 1

    AS REPORTED, "(B)(6) OBESE MALE PATIENT CAME TO THE HOSPITAL WITH A SADDLE PE, THROMBUS INTO LEFT PA AS WELL AS TUMBLING RIGHT ATRIAL THROMBUS. PLAN WAS TO REMOVE TUMBLING RIGHT ATRIAL THROMBUS WITH ANGIOVAC. SURGERY WAS NOT AN OPTION AS HIS RIGHT VENTRICULAR STRAIN WAS QUITE HIGH AND HE WOULDN'T HAVE SURVIVED OPEN HEART SURGERY ACCORDING TO THE CT SURGEON. THE INTERVENTIONAL CARDIOLOGIST SUCCESSFULLY ASPIRATED OVER 40CM OF THROMBUS AND COMPLETED THE CASE IN THE HOPE OF MINIMIZING ADDITIONAL CLOT BURDEN ON THE LUNGS. THE PATIENT WAS STABLE DURING THE ENTIRE PROCEDURE AND IMMEDIATELY AFTER, BUT CODED UPON ARRIVAL IN THE CVICU. ATTEMPTS TO REVIVE HIM WERE UNSUCCESSFUL. THE PATIENT DEATH IS NOT RELATED TO THE PRODUCT (ANGIOVAC) AT ALL." THE DEVICE USED DURING THE PROCEDURE WAS DISCARDED AT THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158970 ANGIODYNAMICS / ANGIOVAC CATHETER, CANNULA & TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF ANGIODYNAMICS H965251860

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Death