MAUDE Adverse Event Report: ATOS MEDICAL AB PROVOX NID 20FR, 6MM; INDWELLING VOICE PROSTHESIS

Model Number	20 Fr
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Pneumonia (2011)
Date of Event	04/29/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report includes a theoretical investigation since no product was returned to the manufacturer.According to the information given in the complaint form.Serious injury: no.Medical intervention required: yes.Early leakage of a prosthesis is mostly caused by food remnants or mucus around the flap towards the sealing surface of the valve seat.The ifu gives the direction to clean the prosthesis thoroughly and regularly, morning and night and after every meal.It is not possible to state why the prosthesis was leaking without examining it.During the manufacturing of a nid prosthesis, there are several visual checks.Leakage- and pressure drop tests are also performed.It is not likely that the prosthesis was leaking when leaving the manufacturing unit at atos medical.The prosthesis is not available for investigation, however, the most likely explanation to the leakage is user error.This conclusion is based on: early leakage is mostly due to stuck food or mucus between the flap and the sealing surface of the blue ring.The ifu states that cleaning should be done after every meal.There was only leakage during one day before the prosthesis was replaced.When replacing, the clinician must check for leakage according to ifu.It is not likely that the prosthesis was damaged when leaving the manufacturing unit at atos medical.Leakage is normally leading to coughing which is an indicator for replacement of the prosthesis.(b)(6) has been consulted and they are stating that pneumonia may develop, but not likely, within 24h if the leakage is severe and the patient has very poor or absent cough reflex.Atos medical does not know if the leakage was severe or if the patient is able to cough properly or if the cough reflex was reduced or absent (there was a previous stay at the hospital which cause is not presented in the complaint description).Conclusion: root cause cannot be unambiguously determined as some facts are missing.However, given that the patient was treated with antibiotics (medical intervention), we prefer to report this as-is to err on the side of caution even if it is difficult to confirm that the pneumonia was a result of a leaking prosthesis that was used for only one day.Note: due to confidentiality reasons, the patient's name is not entered as the initial reporter.Instead, the sales representative's name is used.
Event or Problem Description
This is the event description received from the initial reporter: patient was in hospital for about 1.5 weeks, came home, had additional problems so had to go back in.It turned out the valve was leaking and caused aspiration pneumonia in which she had to be put on antibiotics.Several follow-up questions have been asked and were answered by the customer support representative since it was not possible to reach the user.The user only had the prosthesis for one day.The user went to hospital for other reasons and the doctor diagnosed pneumonia due to the leaking prosthesis.The nid was replaced with another vp so that a plug can be used.The user is out of the hospital and has ordered another nid, which the user is normally using.Description of the product: provox nid is a non-indwelling voice prosthesis for patients who are capable of handling the exchange and maintenance of a voice prosthesis independently of a clinician or physician.The prosthesis is available in two outer shaft diameters (17 and 20 french) and several lengths.The voice prosthesis is seated in a puncture in the wall between esophagus and trachea.

• Brand Name: PROVOX NID 20FR, 6MM
• 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: karolina nilsson ; kraftgatan 8; hörby, 24235 ; SW 24235
• MDR Report Key: 14684371
• Report Number: 8032044-2022-00005
• Device Sequence Number: 14621418
• Product Code: EWL
• UDI-Device Identifier: 07331791000331
• UDI-Public: 07331791000331
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K043138
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/14/2022

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: 20 Fr
• Device Catalogue Number: 7111
• Device Lot Number: 2201087
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2022
• Initial Report FDA Received Date: 06/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2022
• 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