BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALVE IN CARTRIDGE, 7MM

    MDR report key: 19845830 · Received July 26, 2024

    Report

    Report Number
    3004450998-2024-00032
    Event Type
    Injury
    Date Received
    July 26, 2024
    Date of Event
    June 27, 2024
    Report Date
    July 26, 2024
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    NJK
    PMA / PMN Number
    P180007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A TOTAL OF FOUR SPIRATION VALVES WERE PLACED IN THE PATIENT FOR A TOTAL OF FOUR RELATED EVENT REPORTS FILED SEPARATELY FOR THE SAME PATIENT PROCEDURE. THIS IS REPORT ONE OF FOUR ASSOCIATED WITH THIS EVENT. IN THE EMPROVE STUDY, THE INCIDENCE OF SERIOUS PNEUMOTHORAX WAS 14.2%, WITH OVER 75% OF THE SERIOUS PNEUMOTHORAX EVENTS OCCURRING WITHIN THE FIRST 3 DAYS POST-PROCEDURE. EARLY-ONSET PNEUMOTHORAX IN THE TREATMENT GROUP LIKELY RESULTED FROM LUNG CONFORMATION CHANGES DUE TO ACUTE REDUCTION IN LUNG VOLUME BY VALVE THERAPY, TRIGGERING RAPID EXPANSION OF THE IPSILATERAL NON-TARGETED LOBE LEADING TO A PNEUMOTHORAX. (CRINER GJ, DELAGE A, VOELKER K, ET AL. IMPROVING LUNG FUNCTION IN SEVERE HETEROGENOUS EMPHYSEMA WITH THE SPIRATION VALVE SYSTEM (EMPROVE). A MULTICENTER, OPEN-LABEL RANDOMIZED CONTROLLED CLINICAL TRIAL. AM J RESPIR CRIT CARE MED. 2019;200(11):1354-1362. DOI:10.1164/RCCM.201902-0383OC). HOWEVER, IT SHOULD BE NOTED THAT PNEUMOTHORAX EVENTS ARE ALSO RECOGNIZED AS AN INDICATOR OF SUCCESSFUL TARGET LOBE OCCLUSION AND WHEN MANAGED ACCORDING TO PUBLISHED EXPERT GUIDELINES (VALIPOUR A, SLEBOS DJ, DE OLIVEIRA HG, ET AL. EXPERT STATEMENT: PNEUMOTHORAX ASSOCIATED WITH ENDOSCOPIC VALVE THERAPY FOR EMPHYSEMA--POTENTIAL MECHANISMS, TREATMENT ALGORITHM, AND CASE EXAMPLES. RESPIRATION. 2014;87(6):513-521. DOI:10.1159/000360642), SUBJECTS WITH PNEUMOTHORAX EVENTS EXPERIENCED CLINICAL BENEFITS SIMILAR TO THAT IN SUBJECTS WITHOUT PNEUMOTHORAX EVENTS (CRINER GJ, DELAGE A, VOELKER K, ET AL. IMPROVING LUNG FUNCTION IN SEVERE HETEROGENOUS EMPHYSEMA WITH THE SPIRATION VALVE SYSTEM (EMPROVE). A MULTICENTER, OPEN-LABEL RANDOMIZED CONTROLLED CLINICAL TRIAL. AM J RESPIR CRIT CARE MED. 2019;200(11):1354-1362. DOI:10.1164/RCCM.201902-0383OC). THE REPORTED EVENT ALIGNS WITH THE EXPERIENCE IN THE EMPROVE CLINICAL TRIAL AND IS AN EXPECTED ADVERSE EVENT ASSOCIATED WITH THE SPIRATION VALVE SYSTEM.

    Description of Event or Problem · 0

    A PATIENT UNDERWENT VALVE PLACEMENT PROCEDURE FOR THE TREATMENT OF EMPHYSEMA ON (B)(6) 2024. FOUR VALVES WERE PLACED IN THE PATIENT¿S LEFT UPPER LOBE. ONE SVS-V7-00 WAS PLACED IN LB2, ONE SVS-V7-00 WAS PLACED IN LB1, ONE SVS-V9-00 WAS PLACED IN LB3 AND ONE SVS-V9-00 WAS PLACED IN LB4+5. IMMEDIATELY AFTER VALVE PLACEMENT, THE PATIENT EXPERIENCED TENSION PNEUMOTHORAX IN THE LEFT UPPER LOBE. A LEFT ANTERIOR APICAL 14F PIGTAIL CATHETER WAS PLACED IN THE OPERATING ROOM, FOLLOWED BY A LEFT LATERAL 20F CHEST TUBE IN THE POST-ANESTHESIA CARE AFTER VISUALIZATION OF DEVELOPING EMPHYSEMA SUGGESTING A LEAK IN EXCESS OF THE 14F CATHETER¿S INABILITY TO EVACUATE THE AIR LEAK. THE PATIENT EXPERIENCED SYMPTOMATIC RELIEF AFTER BOTH CHEST TUBE INSERTIONS AND WAS TRANSPORTED TO THE HOSPITAL CARE UNIT. OVERNIGHT, CESSATION OF AIR LEAK FROM THE 20F CHEST TUBE WITH WORSENING BREATHING AND PROGRESSIVE SUBCUTANEOUS EMPHYSEMA OF THE CHEST, NECK, AND FACE WAS NOTED. THE 20F LATERAL CHEST TUBE WAS FLUSHED WITH SALINE BUT WAS UNSUCCESSFUL IN RESTORING THE AIR LEAK. THE PATIENT WAS MOVED TO THE ICU. THE ANTERIOR 14F CATHETER HAD ONGOING BRISK EXPIRATORY AIR LEAK BUT THE LATERAL CHEST TUBE WAS NOT LEAKING OR TIDALING. A SECOND 20F CHEST TUBE WAS PLACED ON A RIB SPACE ABOVE THE FIRST LATERAL 20F CHEST TUBE WITH SUBSEQUENT VERY BRISK BLOWING AIR NOTED. ON (B)(6) 2024 THE PATIENT RETURNED TO THE OPERATING ROOM. ALL VALVES WERE OBSERVED TO BE SECURELY IN PLACE WITH NO SIGN OF AIRWAY INJURY OR BLEEDING. THE VALVES WERE SEQUENTIALLY REMOVED. UPON STARTING POSITIVE PRESSURE VENTILATION, THE AIR LEAK FROM ALL THREE CHEST TUBES SUBSIDED BUT TIDALING WAS OBSERVED. VALVES WERE REMOVED GIVEN CLINICAL INSTABILITY. CHEST X-RAY OBTAINED INTRA-PROCEDURALLY SHOWED LUNG WAS FULLY EXPANDED. CHEST TUBES WERE FLUSHED TO ASSURE PATENCY. UPON EXTUBATING, A BRISK AIR LEAK WAS AGAIN NOTED FROM ALL THREE CHEST TUBES. THE CESSATION OF AIR LEAK WITH POSITIVE PRESSURE VENTILATION AND RECURRENCE OF VERY BRISK AIR LEAK WITH TRANSITION TO NATIVE NEGATIVE PRESSURE VENTILATION WAS THOUGHT TO BE DUE TO SIGNIFICANT PATIENT GENERATED AUTO POSITIVE END EXPIRATORY PRESSURE (AUTO-PEEP) TO OVERCOME OBSTRUCTIVE VENTILATORY DEFECT. THE PNEUMOTHORAX RESOLVED ON (B)(6) 2024 WITHOUT SEQUELAE AND PATIENT WAS RELEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1775354 VALVE IN CARTRIDGE, 7MM SPIRATION VALVE NJK GYRUS ACMI, INC. SVS-V7-00 WS274291

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization| R