BEUDAMED
    FDA Adverse Event Death Summary report: N

    ANGIOVAC / ANGIODYNAMICS

    MDR report key: 6237033 · Received January 10, 2017

    Report

    Report Number
    1317056-2017-00004
    Event Type
    Death
    Date Received
    January 10, 2017
    Date of Event
    December 14, 2016
    Report Date
    June 21, 2017
    Manufacturer
    ANGIODYNAMICS
    Product Code
    DWF
    UDI-DI
    H965251850
    PMA / PMN Number
    K142593
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH NO SAMPLE WILL BE RETURNED TO ANGIODYNAMICS FOR EVALUATION, THE INVESTIGATION INTO THIS EVENT IS ON-GOING. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. (B)(4). DEVICE NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED FOR THE INDICATED PACKAGING AND COMPONENT LOTS FOR ANY DEVIATIONS RELATED TO THE REPORTED DEFECT OF THE COMPLAINT. THE REVIEW CONFIRMS THAT THE LOTS MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ANGIODYNAMICS COMPLAINT REPORT WAS REVIEWED FOR THE ANGIOVAC PRODUCT FAMILY AND THE FAILURE MODE "PATIENT INJURY/DEATH." NO ADVERSE TREND WAS IDENTIFIED. ALTHOUGH NO USED DEVICE WAS RETURNED FOR EVALUATION, IT IS NOT BELIEVED THAT A DEVICE MALFUNCTION OCCURRED: INFORMATION FROM THE PHYSICIAN RECEIVED BY ANGIODYNAMICS' SALES REPRESENTATIVE INDICATED THAT " THE PATIENT EXPIRED 1 WEEK AFTER THE PROCEDURE DUE TO HER OVERALL POOR HEALTH STATUS. THE MD DID NOT ATTRIBUTE THE PATIENT'S DEATH TO THE DEVICE." DIRECTIONS FOR USE PROVIDED WITH THE ANGIOVAC CANNULA INCLUDE THE FOLLOWING: "WARNINGS SELECTION OF THE PATIENT AS A CANDIDATE FOR USE WITH THIS DEVICE AND FOR SUCH PROCEDURES AS IT IS INTENDED IS THE PHYSICIANS' SOLE RESPONSIBILITY. THE OUTCOME IS DEPENDENT ON MANY VARIABLES INCLUDING, PATIENT PATHOLOGY, SURGICAL PROCEDURE, AND PERFUSION PROCEDURE/TECHNIQUE. THE BENEFITS OF USE OF THIS DEVICE MUST BE WEIGHED AGAINST THE RISKS INCLUDING RISKS OF SYSTEMIC ANTICOAGULATION AND MUST BE ASSESSED BY THE PRESCRIBING PHYSICIAN. 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 INITIATING AND MONITORING EXTRACORPOREAL BYPASS AND BY PHYSICIANS TRAINED AND EXPERIENCED USING SURGICAL AND/OR PERCUTANEOUS (SELDINGER) VASCULAR ACCESS TECHNIQUES. 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)). DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    AS REPORTED BY ANGIODYNAMICS' CLINICAL SPECIALIST: PATIENT'S INDICATION FOR ANGIOVAC PROCEDURE WAS RIGHT ATRIAL THROMBUS. PATIENT'S CO-MORBIDITIES WERE ENDOCARDITIS, WAS SEPTIC, AND HX OF IVDU. PATIENT WAS STABLE AT TIME OF PROCEDURE, BUT WITH HIGH VENOUS PRESSURES PER MD. PULMONARY EMBOLISM OCCURRED DURING CASE. WHEN THE PE OCCURRED IS UNKNOWN, AS THERE WAS NO VISUALIZATION OF THE EMBOLIZATION. THE PE WAS DIAGNOSED AT THE END OF THE CASE BY MD BASED ON END TIDAL CO2 AND SATURATIONS DECREASING. THE ANGIOVAC WAS OUT OF THE PATIENT AT THAT TIME. THE PATIENT'S CONDITION AT THAT TIME WAS "STABLE." FOLLOW-UP WITH THE PHYSICIAN REGARDING THE PATIENT'S CURRENT STATUS HAS INDICATED THAT THE PATIENT EXPIRED ONE WEEK AFTER THE PROCEDURE DUE TO HER OVERALL POOR HEALTH. THE MD DID NOT ATTRIBUTE THE PATIENT'S DEATH TO THE ANGIOVAC DEVICE. ((B)(4))

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20635 ANGIOVAC / ANGIODYNAMICS CATHETER, CANNULA & TUBING, VASCULAR DWF ANGIODYNAMICS 5020900 H965251850

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Death