MAUDE Adverse Event Report: ATOS MEDICAL AB PROVOX VEGA 22.5 FR 6 MM; INDWELLING VOICE PROSTHESIS

Model Number	4283
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/27/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
An employee of atos medical ab became aware of an event of an aspirated voice prosthesis when writing a book chapter and the co-author used a photo of an aspirated voice prosthesis.From the photograph it was identified that the event dated back to (b)(6) 2020.The photo was from dr.(b)(6) from (b)(6), italy who removed the voice prosthesis with bronchoscopy.We have informed dr.(b)(6) that atos medical ab would like to report the issue and due to very little information concerning the event follow-up questions were sent to dr.(b)(6).The follow-up questions sent to dr.(b)(6) confirmed that it was a provox vega voice prosthesis (22,5 fr 6 mm).The incident happened when the patient coughed at home and arrived at the hospital in rome without symptoms.No dyspnea, no breathing problems.As mentioned, the doctor removed the prosthesis using a bronchoscopy (local anesthesia) and then inserted a longer vega prosthesis.Also after the procedure the patient was feeling well.The doctor did not report the incident since it was deemed as a tissue related problem.Description of the product: provox vega is a one-way valve (prosthesis) that keeps a te-puncture open for speech, while reducing the risk of fluids and food entering the trachea.Provox vega voice prostheses are not permanent implants, and needs periodic replacement.The prosthesis is available in different diameters and several lengths.The device is made of medical grade silicone rubber and fluoroplastic.The voice prosthesis is seated in a puncture in the wall between esophagus and trachea.Intended use: provox vega voice prosthesis is a sterile single use indwelling voice prosthesis intended for voice rehabilitation after surgical removal of the larynx (laryngectomy).Cleaning of the voice prosthesis is performed by the patient while it remains in situ.
Additional Manufacturer Narrative
A theoretical investigation was performed, no product was returned.If the following symptoms occur, the patient should seek medical care immediately: gagging, coughing, choking, wheezing.This is stated in the ifu.There are some reasons for the prosthesis to fall into the trachea: 1.Hooked and pulled out by a too long larybutton.The ifus informs to check length of larybuttons.2.Hooked and pulled out by a provox brush (excessive force during cleaning) or other instruments.The ifu informs how to clean and only use tools that are intended for the vega prostheses.3.Deteriorated silicone material due to candida overgrowth.If the prosthesis has growth of biofilm such as candida, the prosthesis would show that by start leaking.The ifu informs the patient to seek medical help.4.Puncture tissue deformed by radiation, necrosis or similar.The esophagus flange of the prosthesis is more robust than the tracheal flange and is designed in this way to minimize the risk of the prosthesis to fall into trachea.Necrosis may occur of the prosthesis is too short.There is guidance in the ifu how to choose the correct size and length.5.Incorrect insertion, tracheal flanges not unfolded in the trachea.The ifu contains detailed information of insertion methods and checkings of correct position of the prosthesis.In this case it was a tissue related problem that caused the prosthesis to dislodge into the trachea.Based on further information given, it was assessed by the doctor that a longer prosthesis was needed.Conclusion: that a prosthesis dislodges into trachea due to tissue damage/shape and that the prosthesis was too short, is not a product error.The incident was also not assessed as a prosthesis related problem by the treating doctor.Consider medical consultation more often and, if needed, changing the prosthesis.Consider thorough examination when assessing correct size and length of the prosthesis, according to the ifu.The cause code is no product error.Trend analyses are performed monthly.There is no unacceptable trend in the vigilance data.No corrective action/preventive action is considered necessary at this stage.

• Brand Name: PROVOX VEGA 22.5 FR 6 MM
• Common Device Name: INDWELLING VOICE PROSTHESIS
• Manufacturer (Section D): ATOS MEDICAL AB; kraftgatan 8; hörby, 24235 ; SW 24235
• Manufacturer (Section G): ATOS MEDICAL AB; kraftgatan 8; hörby, 24235 ; SW 24235
• Manufacturer Contact: ulrika svensson ; kraftgatan 8; horby, SE-24-235 ; SW SE-24235
• MDR Report Key: 18053725
• Report Number: 8032044-2023-00003
• Device Sequence Number: 19663821
• Product Code: EWL
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K090455
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 4283
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2023
• Initial Report FDA Received Date: 11/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown