BEUDAMED
    FDA Adverse Event Death Summary report: N

    EVIS EXERA III BRONCHOVIDEOSCOPE

    MDR report key: 14166846 · Received April 21, 2022

    Report

    Report Number
    8010047-2022-06764
    Event Type
    Death
    Date Received
    April 21, 2022
    Date of Event
    March 20, 2022
    Report Date
    June 13, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    EOQ
    UDI-DI
    04953170335174
    PMA / PMN Number
    K121959
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE INVESTIGATION IS IN PROCESS. THE LITERATURE ARTICLE IS ATTACHED FOR ADDITIONAL INFORMATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH DEVICE EVALUATION RESULTS.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE DEVICE HISTORY RECORD WAS UNABLE TO BE REVIEWED FOR THIS DEVICE SINCE THE LOT NUMBER WAS NOT PROVIDED. HOWEVER, OLYMPUS ONLY RELEASES PRODUCTS TO MARKET THAT MEET ALL MANUFACTURING SPECIFICATIONS AND FINAL PRODUCT RELEASE CRITERIA. BASED ON THE RESULTS OF THE INVESTIGATION, THE RELATIONSHIP BETWEEN THE DEVICE AND THE ADVERSE EVENT CANNOT BE CONFIRMED. THERE WAS NO COMPLAINT REPORTED ON THE SUBJECT DEVICE. THERE IS NO EVIDENCE OF AN OLYMPUS DEVICE MALFUNCTION. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    OLYMPUS REVIEWED THE FOLLOWING LITERATURE: COVID-19 PATIENTS PRESENTING WITH POST-INTUBATION UPPER AIRWAY COMPLICATIONS: A PARALLEL EPIDEMIC? BY GRIGORIS STRATAKOS, ET AL. ABSTRACT: DURING THE CURRENT PANDEMIC, WE WITNESSED A RISE OF POST-INTUBATION TRACHEAL STENOSIS (PITS) IN PATIENTS INTUBATED DUE TO COVID-19. WE PROSPECTIVELY ANALYZED DATA FROM PATIENTS REFERRED TO OUR INSTITUTION DURING THE LAST 18 MONTHS FOR SEVERE SYMPTOMATIC POST-INTUBATION UPPER AIRWAY COMPLICATIONS. INTERDISCIPLINARY BRONCHOSCOPIC AND/OR SURGICAL MANAGEMENT WAS OFFERED. TWENTY-THREE PATIENTS WITH PITS AND/OR TRACHEOESOPHAGEAL FISTULAE WERE INCLUDED. THEY HAD UNDERGONE 31.85 (±22.7) DAYS OF ICU HOSPITALIZATION AND 17.35 (±7.4) DAYS OF INTUBATION. TRACHEAL STENOSIS WERE MOSTLY COMPLEX, LOCATED IN THE SUBGLOTTIC OR MID-TRACHEAL AREA. A TOTAL OF 83% OF PATIENTS HAD FRACTURE AND DISTORTION OF THE TRACHEAL WALL. FIFTEEN PATIENTS WERE INITIALLY TREATED WITH RIGID BRONCHOSCOPIC MODALITIES AND/OR STENT PLACEMENT AND EIGHT PATIENTS WITH TRACHEAL RESECTION-ANASTOMOSIS. POST-TREATMENT RELAPSE IN TWO OF THE BRONCHOSCOPICALLY TREATED PATIENTS REQUIRED SURGERY, WHILE TWO OF THE SURGICALLY TREATED PATIENTS REQUIRED RIGID BRONCHOSCOPY AND STENT PLACEMENT. TRANSIENT, NON-LIFE-THREATENING POST-TREATMENT COMPLICATIONS DEVELOPED IN 60% OF PATIENTS AND WERE ALL MANAGED SUCCESSFULLY. THE HISTOPATHOLOGY OF THE RESECTED TRACHEAL SPECIMENS DIDN¿T REVEAL SPECIFIC ALTERATIONS IN COMPARISON TO PRE-COVID-ERA PITS CASES. PROLONGED INTUBATION, PRONATION MANEUVERS, OVERSIZED TUBES OR CUFFS, AND PATIENT- OR DISEASE-SPECIFIC FACTORS MAY BE PATHOGENICALLY IMPLICATED. AN INCREASE OF POST-COVID PITS IS ANTICIPATED. CAREFUL PREVENTION, EARLY DETECTION AND EFFECTIVE MANAGEMENT OF THESE IATROGENIC COMPLICATIONS ARE WARRANTED. ADVERSE EVENTS: ONE PATIENT DEVELOPED A PNEUMOTHORAX DURING THE RIGID BRONCHOSCOPY PROCEDURE DIRECTLY AFTER INITIATION OF JET VENTILATION AND IMMEDIATELY HAD A CHEST DRAIN INSERTED. AFTER A SUCCESSFUL EVACUATION AND RESOLUTION OF THE PNEUMOTHORAX, A BRONCHOSCOPY WAS REPEATED THE FOLLOWING WEEK AND A STENT IMPLANTATION TOOK PLACE SUCCESSFULLY WITHOUT FURTHER COMPLICATIONS. THE REST OF THE COMPLICATED PATIENTS HAD A RELAPSE OF TRACHEAL STENOSIS ON VARIOUS OCCASIONS WITHIN ONE MONTH AFTER DEPLOYMENT OF THE STENTS DUE TO PSEUDOMEMBRANOUS OR THICK PURULENT SECRETIONS OBSTRUCTING THE STENT. THESE WERE EVENTUALLY SUCTIONED, AND THE THICK OR PSEUDOMEMBRANOUS MATERIAL WAS REMOVED USING A CRYOPROBE. ONE PATIENT PRESENTED WITH MUCUS RETENTION AND PSEUDOMEMBRANOUS FORMATION CAUSING TRACHEAL STENOSIS AND STENT MIGRATION 4 WEEKS AFTER THE INITIAL PLACEMENT OF THE STENT. PSEUDOMEMBRANES WERE REMOVED AND THE STENT WAS REPOSITIONED SUCCESSFULLY IN TWO CASES, THE STENTS HAD TO BE REMOVED DUE TO CONTINUOUS MUCOUS ACCUMULATION AND INTENSE COUGHING, AND THESE PATIENTS WERE SUBSEQUENTLY REFERRED TO SURGERY ACHIEVING SUCCESSFUL MANAGEMENT. NO OTHER MAJOR COMPLICATION WAS NOTED. DURING FOLLOW-UP, WE HAD ONE DEATH REFERRING TO THE NON-OPERABLE PATIENT WITH TEF AND DOUBLE STENTING WHO DIED OF SEPTIC COMPLICATIONS AFTER 3 MONTHS OF HOSPITALIZATION. THIS ARTICLE INCLUDES 2 REPORTS: (B)(6) IS FOR THE PATIENT WITH SEPSIS AND DIED. (B)(6) IS FOR ALL OTHER ADVERSE EVENTS. THIS REPORT IS 1 OF 2 FOR: (B)(6) IS FOR THE PATIENT WITH SEPSIS AND DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1713673 EVIS EXERA III BRONCHOVIDEOSCOPE BRONCHOVIDEOSCOPE EOQ OLYMPUS MEDICAL SYSTEMS CORP. BF-H190 04953170335174

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other| D