BEUDAMED
    FDA Adverse Event Death Summary report: N

    BIORESORBABLE AIRWAY SPLINT

    MDR report key: 16817476 · Received April 25, 2023

    Report

    Report Number
    MW5117054
    Event Type
    Death
    Date Received
    April 25, 2023
    Date of Event
    July 19, 2023
    Report Date
    September 1, 2023
    Manufacturer
    GLOBAL CENTER FOR MEDICAL INNOVATION
    Product Code
    LYA
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED FROM REPORTER FOR REPORT MW5117054 ON 9/6/2023. A BIORESORBABLE AIRWAY SPLINT DEVICE IN COLLABORATION WITH THE (B)(6) WAS SUCCESSFULLY IMPLANTED INTO A FEMALE INFANT ON (B)(6) 2023 AT THE (B)(6). POSTOPERATIVELY, HER RESPIRATORY STATUS IMPROVED SUCH THAT SHE WAS EXTUBATED FOR APPROXIMATELY ONE WEEK IN EARLY FEBRUARY. UNFORTUNATELY, HER RESPIRATORY STATUS STEADILY DECLINED THEREAFTER, EVENTUALLY REQUIRING TRACHEOSTOMY AS WE HAD ANTICIPATED. OVER THE NEXT SEVERAL MONTHS, SHE DEVELOPED SEVERAL RESPIRATORY TRACT INFECTIONS REQUIRING PROLONGED COURSES OF ANTIBIOTICS. SUBSEQUENT ENDOSCOPIC EVALUATIONS AND CT IMAGING DEMONSTRATED DEVICE EROSION INTO HER RECONSTRUCTED AIRWAY. THIS ADVERSE EVENT WAS REPORTED TO THE FDA ON (B)(6) /2023 AND WAS ASSIGNED MW5117054. AS YOU KNOW, THE DEVICE WAS USED IN THE UNIQUE INDICATION OF TRACHEAL AGENESIS WITH THE AIRWAY LACKING CARTILAGE RINGS. SINCE THE AIRWAY WAS ESOPHAGEAL TISSUE, THIS LIKELY PLAYED A SIGNIFICANT ROLE IN THE EROSION. ON (B)(6) 2023, SHE WAS RE-HOSPITALIZED AT (B)(6) WITH SEPSIS AND EVENTUALLY DEVELOPED MULTI-SYSTEM ORGAN FAILURE. THE DEGREE OF DEVICE EROSION REMAINED STABLE AT THAT TIME. AFTER DISCUSSIONS WITH FAMILY, CARE WAS WITHDRAWN ON (B)(6) 2023, AND THE PATIENT EXPIRED LATER THAT DAY. AN AUTOPSY WAS DECLINED. SINCE THERE WAS NEVER ANY MEDIASTINITIS FROM THE DEVICE EROSION, IT REMAINS UNCLEAR WHETHER THE DEVICE CONTRIBUTED TO HER SEPSIS.

    Description of Event or Problem · 0

    EVIDENCE OF BIORESORBABLE AIRWAY SPLINT EROSION INTO PATIENT'S AIRWAY AT 3 MONTHS POSTOP IMPLANTATION. THE EVENT WAS NOTED ON ROUTINE BRONCHOSCOPY AND CONFIRMED BY CHEST CT SCAN. NO EFFECT ON PATIENT CLINICAL CONDITION NOTED THUS FAR. SPLINT FUNCTION IN MAINTAINING AIRWAY PATENCY REMAINS INTACT. EVIDENCE OF MULTIPLE SPLINT SUTURES ALONG THE ANTERIOR WALL OF THE AIRWAY ON BRONCHOSCOPY. FOLLOW UP CT SHOWED NO INFECTION OR EXTRALUMINAL TRACKING OF AIR. PATIENT REMAINS CLINICALLY STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1336696 BIORESORBABLE AIRWAY SPLINT SPLINT, INTRANASAL SEPTAL LYA GLOBAL CENTER FOR MEDICAL INNOVATION

    Patients

    Seq Age Sex Outcome Treatment
    1 12 MO Female Other| D