MAUDE Adverse Event Report: ATOS MEDICAL AB PROVOX VEGA 22.5 FR 10 MM; INDWELLING VOICE PROSTHESIS

Model Number	8285
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/20/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A theoretical investigation was performed, since the product was disposed by the hospital after the event.A company representative in the clinical team was consulted.Discussion: that a vega should dislodge is unusual, given how robust this prosthesis is.There could be some explanations to the failure.The patient has issues with tissue, peripheral leak or enlarged tissue around vp.The prosthesis may have been too short.The patient used excessive force when cleaning the prosthesis.The designs of the flanges are made so that the retention force of the esophagus flange is significantly larger than for the tracheal flange.This is made to prevent the prosthesis to dislodge into trachea.Conclusion/action: since the prosthesis could not be examined, the reason for the failure mode could not be established.It is likely not a product error.No corrective action/preventive action is considered necessary at this stage and there are no unacceptable trends found in the complaint statistics.
Event or Problem Description
Provox vega 22.5 fr 10 mm was dislodged into the esophagus side while the patient was hospitalized.The incident required medical intervention.(b)(6) 2023: while the patient was eating at the hospital (unknown breakfast, lunch or dinner), the indwelled voice prosthesis was dislodged into the patient's esophagus side.The patient called a nurse for help by him/herself.The doctor came and confirmed that the voice prosthesis was stuck in the esophagus and was taken out by means of an endoscope.The actual voice prosthesis (ref 8285) was disposed by the hospital because the hospital determined not to report this as an incident internally.12/01/2023: a sales representative from atos medical visited the hospital to hear about the incident.The incident was discussed with doctor and head nurse which confirmed that the voice prosthesis had not leaked at all and was not broken - looked in a good condition.Therefore, it was determined that it was not caused by the product and the voice prosthesis was disposed.The voice prosthesis was indwelled closer to, and just beside the stoma, because the patient had a kucyo saiken procedure and there was not an option of a good position for making the fistula.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.

• Brand Name: PROVOX VEGA 22.5 FR 10 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: sofia thomasson ; kraftgatan 8; horby, SE-24-235 ; SW SE-24235
• MDR Report Key: 18324824
• Report Number: 8032044-2023-00004
• Device Sequence Number: 17989753
• Product Code: EWL
• UDI-Device Identifier: 07331791010897
• UDI-Public: 07331791010897
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 12/13/2023

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: 8285
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2023
• Initial Report FDA Received Date: 12/14/2023
• 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