BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROVOX2

    MDR report key: 21362807 · Received February 12, 2025

    Report

    Report Number
    8032044-2025-00004
    Event Type
    Injury
    Date Received
    February 12, 2025
    Report Date
    February 12, 2025
    Manufacturer
    ATOS MEDICAL AB
    Product Code
    EWL
    UDI-DI
    07331791010026
    PMA / PMN Number
    K971244
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONCLUSION PRODUCT FAILURE CANNOT BE CONCLUDED. IT IS ASSUMED THAT THE PROTRUSION OF THE VOICE PROSTHESIS WAS CAUSED BY AN ENLARGED PUNCTURE. INVESTIGATION THIS IS A THEORETICAL INVESTIGATION. THE DESCRIPTION IN THIS COMPLAINT WAS FOUND IN LITERATURE (EBERSOLE, 2024. THE PATIENT HAS AN ENLARGED PUNCTURE AND TRIALS WERE TAKEN WITH COMMERCIAL COLLARS AS WELL AS CUSTOMIZING COLLARS AND USE OF LARYTUBE. THIS REPORT IS OF THE 5 TIMES THE PATIENT HAD TO GO TO HOSPITAL WHEN THE VOICE PROSTHESIS PROVOX2 WITH CUSTOMIZED FLANGES/COLLARS WERE USED. ANY MODIFICATION OF THE DEVICES ARE UNDER THE RESPONSIBILITY OF TREATING CLINICIANS. FOLLOW UP QUESTIONS: - REF NUMBER ON ANY OF PROVOX2? ANSWER: REF 7218 PROVOX2 VOICE PROSTHESIS 8MM - WHICH LARYTUBE WAS USED? (10/55 ¿ BRAND NOT SPECIFIED, POSSIBLY NOT A PROVOX LARYTUBE) - ARE ANY ANY LOT NUMBERS AVAILABLE OF THE PRODUCTS? (NO INFORMATION) - THE 5 VOICE PROSTHESES USED WHEN GOING TO ER; WERE THOSE MODIFIED? ANSWER: ¿THE 5 EVENTS THAT LED TO THE EMERGENCY ROOM WERE ONLY WHILE WERE USING (PROVOX2 THAT WERE POSSIBLY MODIFIED WITH ENLARGED SILICONE COLLARS GLUED ONTO THE ANTERIOR AND POSTERIOR FLANGES BY OUR ANAPLASTOLOGIST. THE REASON FOR THE DISLODGEMENT WAS NOT DUE TO THE PROSTHESIS ITSELF, BUT RATHER, DUE TO THE PATIENT¿S ANATOMY (SEVERELY ENLARGED PUNCTURE) AS WELL AS DUE TO HIS/HERS USE OF A LARYTUBE FOR STOMAL STENOSIS, AND SELF-DILATION OF ESOPHAGUS (BOTH OF WHICH WOULD DISLODGE THE PROSTHESIS AT TIMES WHEN INSERTING). ROOT CAUSE THE PATIENT HAS AN ENLARGED PUNCTURE. DISCUSSION ACCORDING TO IFU 10877 (PROVOX2) AT SECTION WARNING: INFORM THE PATIENT TO USE ONLY ORIGINAL PROVOX ACCESSORIES OF CORRESPONDING SIZE FOR MAINTENANCE AND TO AVOID ALL OTHER KINDS OF MANIPULATION OF THE VOICE PROSTHESIS. ACCORDING TO IFU 11671 (LIFE LARYTUBE) AT SECTION CONTRAINDICATION: PROVOX LIFE LARYTUBE IS NOT INTENDED TO BE USED BY PATIENTS THAT¿ HAVE DAMAGED TRACHEAL OR TRACHEOSTOMA TISSUE. ACCORDING TO IFU 11671 (LIFE LARYTUBE) AT SECTION PRECAUTION: DO NOT USE FORCE DURING INSERTION. DO NOT USE A DAMAGED DEVICE. TRENDING NO UNFAVORABLE TRENDS DETECTED. RISK ASSESSMENT RH023-01-HAZ, H07: ASPIRATION OF PROSTHESIS, INSERTION SYSTEM OR PARTS OF IT INTO THE LUNGS LEADING TO PULMONARY INFECTION, REMOVED ENDOSCOPICALLY BY PHYSICIAN. S = 6. COMMENT: THE ARTICLE DESCRIBES 5 SEPARATE EVENTS WITH THE SAME MODIFIED DEVICE. 5 SEPARATE REPORTS WILL THEREFORE BE SUBMITTED TO FDA.

    Description of Event or Problem · 0

    THIS REPORT REFLECTS ASPIRATION OF PROVOX2 WITH MODIFIED FLANGES EVENT 2 OUT OF 5 WHERE TRACHEAL RETRIEVAL WAS NECESSARY. ADVERSE EVENTS WERE FOUND DURING LITERATURE REVIEW FOR THE PERIODIC UPDATE OF THE CLINICAL EVALUATION REPORT FOR VOICE PROSTHESES. THE FOLLOWING TEXT WAS FOUND IN ARTICLE BY EBERSOLE BM, ZAFEREO M, HUTCHESON KA. A CUSTOM DEVICE FOR MANAGING RECURRENT TRACHEOESOPHAGEAL VOICE PROSTHESIS DISLODGEMENT AND ASPIRATION DUE TO TREATMENT REFRACTORY, SEVERELY ENLARGED PUNCTURE: A VIDEO CASE REPORT. HEAD & NECK. 2024;1-7. DOI:10.1002/ HED.27766). "HE WAS EVENTUALLY REFRACTORY TO THESE TREATMENTS AND USING A PROVOX 2 WITH CUSTOMIZED ANTERIOR AND POSTERIOR FLANGES (UP TO 30 MM DIAMETER SILICONE COLLARS), ACHIEVING VARIABLE ASPIRATION CONTROL. SILICONE OF VARYING THICKNESSES (0.015¿0.030 MM) AND DIAMETERS (23¿30 MM) WERE TRIALED IN THE FABRICATION OF HIS CUSTOM FLANGES TO IMPROVE THEIR STABILITY/SUPPORT, BUT WITH LITTLE EFFECT. IN THE 2 YEARS PRECEDING THE USE OF THE NEW INSET-VP DEVICE, 24 VP DISLODGEMENTS WERE REPORTED WITH 5 REQUIRING ED ADMISSION FOR TRACHEAL RETRIEVAL. ROOT CAUSES OF VP DISLODGEMENT WERE JUDGED TO BE DUE TO DISRUPTION OF FLANGE SEATING DURING SELF-DILATION (POSTERIOR FLANGE) AND/OR WITH LARYTUBE INSERTION/REMOVAL (ANTERIOR FLANGE). HOWEVER, CONTINUATION OF SELF-DILATION AND LARYTUBE USE WERE NONNEGOTIABLE FOR MAINTENANCE OF ORAL DIET AND AIRWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1044039 PROVOX2 TRACHEOESOPHAGEAL SPEECH VALVE, INDWELLING EWL ATOS MEDICAL AB 07331791010026

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention