BEUDAMED
    FDA Adverse Event Other Summary report: N

    IBV VALVE SYSTEM

    MDR report key: 2001117 · Received February 17, 2011

    Report

    Report Number
    3004450998-2011-00001
    Event Type
    Other
    Date Received
    February 17, 2011
    Date of Event
    February 9, 2011
    Report Date
    February 17, 2011
    Manufacturer
    SPIRATION, INC.
    Product Code
    OAZ
    PMA / PMN Number
    H060002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SPIRATION REVIEWED DEVICE LABELING (INSTRUCTIONS FOR USE AND PATIENT BROCHURE) AND CONFIRMED THAT: THE ADVERSE EVENT (PNEUMOTHORAX) WAS LISTED AS POTENTIAL/ANTICIPATED, AND THE USE OF THE IBV VALVES WAS OFF-LABEL. METHOD: REVIEWED THE (B)(4) REPORT SENT BY THE PHYSICIAN TO HIS IRB ON (B)(6) 2011. BASED ON THE REVIEW OF THE (B)(4) REPORT, THE IBV VALVE IS NOT SUSPECTED TO HAVE FAILED OR MALFUNCTIONED. THIS REPORT IS BEING SUBMITTED AS AN MDR WITH AN ABUNDANCE OF CAUTION. IF ADDITIONAL SIGNIFICANT INFO IS PROVIDED, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    PT (B)(6) UNDERWENT A BRONCHOSCOPY PROCEDURE PERFORMED BY DR. (B)(6) ON (B)(6) 2011 FOR IBV VALVE PLACEMENT (OFF-LABEL USE) TO TREAT THE GIANT BULLAE IN THE LEFT UPPER LOBE. A POST-PROCEDURE CHEST X-RAY ON (B)(6) 2011 COULD NOT RULE OUT A PNEUMOTHORAX; HOWEVER, THE PT WAS HEMODYNAMICALLY STABLE. ON (B)(6) 2011, A REPEAT CHEST X-RAY WAS PERFORMED WHICH ALSO COULD NOT CONFIRM OR RULE OUT PNEUMOTHORAX. A CT SCAN WAS THEN REQUESTED AND A PNEUMOTHORAX WAS VISIBLE WITH LEFT LOWER LOBE COLLAPSE AND MEDIASTINAL SHIFT TO THE RIGHT. THE PT BECAME TACHYCARDIC, HYPOTENSIVE, AND WAS IN RESPIRATORY DISTRESS. A CHEST TUBE WAS PLACED AND CONNECTED TO WALL SUCTION WITH CLINICAL AND RADIOGRAPHICAL IMPROVEMENT. THE (B)(4) REPORT TO THE IRB DATED (B)(6) 2011 STATED THAT: THE EVENT WAS PROBABLY RELATED TO THE DEVICE BASED ON THE TIMELINE OF THE EVENT WITHIN 24 HOURS OF THE PROCEDURE, THE EVENT DID NOT INCREASE THE LIKELY RISK OR DECREASE THE LIKELY BENEFIT TO PTS, AND THIS RISK IS EXPECTED AS IT IS LISTED IN THE PT BROCHURE GIVEN TO PT DURING THE CONSENT PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IBV VALVE SYSTEM ONE-WAY AIR LEAK VALVE OAZ SPIRATION, INC. W04036-01

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| L