BEUDAMED
    FDA Adverse Event Death Summary report: N

    VALVE IN CARTRIDGE, 5MM

    MDR report key: 16870960 · Received May 4, 2023

    Report

    Report Number
    3004450998-2023-00032
    Event Type
    Death
    Date Received
    May 4, 2023
    Report Date
    May 4, 2023
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    OAZ
    UDI-DI
    00896506002088
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A JOURNAL PUBLICATION (J BRONCHOLOGY INTERV PULMONOL. 2023 APR 3. DOI: 10.1097/LBR.0000000000000919. EPUB AHEAD OF PRINT. PMID: 37010814) REPORTED A CASE UTILIZING ONE 5MM SPIRATION VALVE FOR HEMOPTYSIS CAUSED BY VASCULAR COIL EROSION IN HUGHES-STOVIN SYNDROME. NO DEVICE MALFUNCTION WAS REPORTED. THE REPORTED USE OF THE SPIRATION VALVE IS AN OFF-LABEL USE OF THE DEVICE. THE MODEL NUMBER OF THE DEVICE IS UNKNOWN. AUTHOR HAS BEEN CONTACTED FOR ADDITIONAL INFORMATION. AUTHOR CONTACTED TO DETERMINE IF VALVE WAS REMOVED.

    Description of Event or Problem · 0

    A LITERATURE CASE STUDY PRESENTED ON THE BRONCHOSCOPIC MANAGEMENT OF HEMOPTYSIS CAUSED BY AIRWAY EROSION FROM VASCULAR COILS.   PATIENT SUFFERED FROM HUGHES-STOVIN SYNDROME, ANTIPHOSPHOLIPID ANTIBODY SYNDROME, AND RECURRENT PULMONARY EMBOLI RECEIVING CHRONIC IMMUNE SUPPRESSION AND CHRONIC ANTICOAGULATION AND PRESENTED WITH MASSIVE HEMOPTYSIS. ONE YEAR PRIOR, THE PATIENT HAD DEVELOPED MASSIVE HEMOPTYSIS DUE TO A LEFT LOWER LOBE PULMONARY ARTERY ANEURYSMAL RUPTURE TREATED WITH SURGICAL RESECTION.  THREE MONTHS PRIOR, A PATIENT DEVELOPED MASSIVE HEMOPTYSIS SECONDARY TO THE RIGHT LOWER LOBE (RLL) ANEURYSMAL RUPTURE, WHICH WAS TREATED WITH VASCULAR COIL EMBOLIZATION. CROSS-SECTIONAL IMAGING AT THE SITE SHOWED THE MOST LIKELY SOURCE OF BLEEDING TO BE AN EROSION OF A VASCULAR COIL THROUGH A VESSEL WALL INTO THE RLL ANTERIOR SEGMENT BRONCHUS.  BILATERAL AIRWAY INSPECTION SHOWED NO FRESH BLEEDING AND NO GROSSLY APPARENT VASCULAR ABNORMALITIES BUT A SMALL AMOUNT OF OLD BLOOD IN THE RLL BRONCHIAL TREE AND VASCULAR COILS VISIBLE IN THE R B8 SEGMENTAL BRONCHUS.  IT WAS DECIDED TO ATTEMPT TO MAXIMIZE LOCAL CONTAINMENT IN THE EVENT OF MASSIVE FUTURE RE-BLEEDING FROM WITH AREA. THE PATIENT WAS REFERRED FOR BRONCHOSCOPIC MANAGEMENT TO MAXIMIZE LOCAL CONTAINMENT IN THE EVENT OF MASSIVE FUTURE RE-BLEEDING FROM THE AREA (RIGHT LOWER LOBE). MULTIPLE SURGICEL STRIPS WERE PLACED IN R B8 TO BOLSTER LOCAL HEMOSTASIS. A COMBINATION OF SPIRATION ENDOBRONCHIAL VALVE (EBV) AND TISSEEL FIBRIN GLUE ON EITHER SIDE OF THE VALVE WAS PLACED MORE PROXIMALLY. AROUND 1-MONTH AFTER SURGICAL REFERRAL, IT WAS REPORTED THE PATIENT SUFFERED ANOTHER MASSIVE HEMOPTYSIS (POSSIBLY DUE TO DISINTEGRATION OF THE VALVE-GLUE COMPLEX OVER TIME OR DUE TO A FRESH ANEURYSMAL RUPTURE) THAT RESULTED IN CARDIAC ARREST AND ULTIMATELY PATIENT DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    860398 VALVE IN CARTRIDGE, 5MM SPIRATION VALVE OAZ GYRUS ACMI, INC. HUS-V5 00896506002088

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Male Death