BEUDAMED
    FDA Adverse Event Death Summary report: N

    VALVE IN CARTRIDGE, 9MM

    MDR report key: 8622043 · Received May 17, 2019

    Report

    Report Number
    3004450998-2019-00006
    Event Type
    Death
    Date Received
    May 17, 2019
    Report Date
    May 17, 2019
    Manufacturer
    SPIRATION
    Product Code
    OAZ
    UDI-DI
    00896506002309
    PMA / PMN Number
    PMA P180007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS NOTED ABOVE, THE PHYSICIAN INDICATED THAT THE PATIENT DEATH WAS DEFINITELY NOT RELATED TO THE VALVE. BUT BECAUSE HE SAID IT COULD POSSIBLE BE RELATED TO THE BRONCHOSCOPIC LUNG VOLUME REDUCTION (BLVR) PROCEDURE, SPIRATION HAS CHOSEN TO REPORT THIS EVENT. NOTE THAT THE PRODUCT CODE FOR THIS USE OF THE SPIRATION VALVE IS NJK, PULMONARY VALVE TO IMPROVE LUNG FUNCTION IN PATIENTS WITH EMPHYSEMA. DEVICE NOT RETURNED; AE NOT DEV RELATED.

    Description of Event or Problem · 1

    A (B)(6) YEAR OLD FEMALE WITH ADVANCED EMPHYSEMA HAD THREE VALVES PLACED ¿ TWO 9MM AND ONE 7MM. THE PATIENT HAD A HISTORY OF CHRONIC CARDIOMYOPATHY, SYSTOLIC HEART FAILURE, ATRIAL FLUTTER, CAD AND TIA IN THE PAST WITHOUT ANY RESIDUAL DEFICITS. SHE HAD SEVERE BUT STABLE RIGHT INTERNAL CAROTID ARTERY OCCLUSION AND DISEASE. PATIENT WAS EVALUATED BY HER CARDIOLOGIST AND HAD A WORKUP PRIOR TO PROCEDURE THAT INCLUDED A RHC AND STRESS TESTS PLUS ECHO AND DEEMED OK FOR PROCEDURE. SHE WAS ON PLAVIX WHICH WAS HELD FOR THE PROCEDURE AND ONLY AFTER CLEARANCE FROM HER CARDIOLOGIST THAT WE COULD SAFELY HOLD IT BEFORE AND AFTER THE PROCEDURE. SHE HAD AFIB THE 2ND DAY POST-PROCEDURE THAT WAS RATE CONTROLLED WITH LOPRESSOR. SHE WAS PLACED BACK ON PLAVIX AND ASA WITH FOLLOW-UP BY HER CARDIOLOGIST 3 DAYS POST-PROCEDURE. PER CARDIOLOGIST SHE FELT MUCH BETTER BREATHING WISE AND LOOKED TERRIFIC AND WAS GOING TO DO A TEE AND ELECTIVE CARDIOVERSION. HE WANTED TO ADD ANOTHER ORAL ANTICOAGULANT TO HER REGIME. DR. (B)(6)¿S OFFICE LEARNED THREE DAYS LATER (6 DAYS POST-PROCEDURE) THAT THE PATIENT HAD A STROKE AND DIED. DR. (B)(6) SAID THE DEATH WAS DEFINITELY NOT RELATED TO THE VALVE BUT THAT IT COULD POSSIBLY BE RELATED TO THE BRONCHOSCOPY PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415412 VALVE IN CARTRIDGE, 9MM SPIRATION VALVE OAZ SPIRATION SVS-V9-00 UNKNOWN 00896506002309

    Patients

    Seq Age Sex Outcome Treatment
    1 Death