MAUDE Adverse Event Report: ATOS MEDICAL AB PROVOX VEGA XTRASEAL 22.5FR 12.5MM; VOICE PROSTHESIS

Catalog Number	7786
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation: this is an initial report.Investigation will be performed but it seems that the xtraseal that was placed was too long, causing food to drag it down.So most likely ingested (and come out the natural way).An xtraseal is typically placed in a puncture that is a bit enlarged so it could more easily dislodge, and it is designed to dislodged more easily to the esophagus.Device is not available for evaluation.
Event or Problem Description
This is the information that was received from the atos medical local representative: patient has now strong concerns when to try to cough strongly because of possible aspiration/ingestion.So he would like to know the possible reason and countermeasure to them.And he expect if any foods might catch the esophageal side of the extruded vp.Patient's history to event: - (b)(6) 2017; replaced vega 22.5fr 8 mm into new one (8 mm) because of leakage.- (b)(6); replaced into xtraseal 10 mm because of leakage.- (b)(6); replaced into xtraseal 12.5 mm because of leakage.A nurse reminded that the new vp seemed so long that it was extruded toward esophageal side.The doctor reminded that the status of shunt hole of the patient seemed good.- (b)(6); during dinner, the patient got stuck in his throat and (we are not sure exactly) the vp was aspirated/ingested accidentally.At that day, he went to the hospital to ask to indwell another new vp of xs 12.5 mm.As of today, the doctor has not confirmed where the missing vp is, but there are no symptoms related to aspiration on the patient.- (b)(6); at lunch, he choked over when he drunk.The vp was aspirated/ingested again.In that afternoon, he went to the hospital.Then, placed vega 10 mm.At the same day, our reps received this information.The patient would like to know the reason of aspiration/ingestion and how to keep the indwelled vp longer and stable.
Additional Manufacturer Narrative
Investigation: the product was not returned in this complaint, an investigation of the product is therefore not possible.Discussion: the provox vega voice prosthesis is designed with a sturdier esophageal flange than tracheal flange that will minimize the risk of aspiration thus if the vp comes loose it will most likely end up in esophagus and out the "natural way".In a healthy round te puncture the flanges give a stable fit that resist coughing/choking thus should not dislodge.One could speculate, if the te puncture is asymmetric the flanges has lost part of its support thus have less resistance to coughing and can come loose.One could also consider using provox xtraflange to reduce periprosthetic leakage.It should be unlikely that food catch the esophageal side of the extruded vp and dislodge the vp.However with excessive long vp the risk increases.It is important to try out the correct size of prosthesis to the patient.Device is not available for evaluation.
Event or Problem Description
This is the information that was received from the atos medical local representative: patient has now strong concerns when to try to cough strongly because of possible aspiration/ingestion.So he would like to know the possible reason and countermeasure to them.And he expect if any foods might catch the esophageal side of the extruded vp.Patient's history to event: on (b)(6) 2017; replaced vega 22.5fr 8mm into new one (8mm) because of leakage.(b)(6); replaced into xtraseal 10mm because of leakage.(b)(6); replaced into xtraseal 12.5mm because of leakage.A nurse reminded that the new vp seemed so long that it was extruded toward esophageal side.The doctor reminded that the status of shunt hole of the patient seemed good.(b)(6); during dinner, the patient got stuck in his throat and (we are not sure exactly) the vp was aspirated/ingested accidentally.At that day, he went to the hospital to ask to indwell another new vp of xs 12.5 mm.As of today, the doctor has not confirmed where the missing vp is, but there are no symptoms related to aspiration on the patient.(b)(6); at lunch, he choked over when he drunk.The vp was aspirated/ingested again.In that afternoon, he went to the hospital.Then, placed vega 10mm.At the same day, our reps received this information.The patient would like to know the reason of aspiration/ingestion and how to keep the indwelled vp longer and stable.Additional information in this follow up report, 2017-06-16: the doctor did a chest and an abdominal ct on the patient this week and found no vp remaining in his body.The doctor regarded it as being already gone-out of the body and patient seemed to be relieved.This case was closed.

• Brand Name: PROVOX VEGA XTRASEAL 22.5FR 12.5MM
• Common Device Name: VOICE PROSTHESIS
• Manufacturer (Section D): ATOS MEDICAL AB; kraftgatan 8; horby, SE-24 222; SW SE-24222
• MDR Report Key: 6629047
• Report Number: 8032044-2017-00007
• Device Sequence Number: 19077431
• Product Code: EWL
• UDI-Device Identifier: 07331791010576
• UDI-Public: 7331791010576
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K090455
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2017

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: Health Professional
• Device Catalogue Number: 7786
• Was Device Available for Evaluation?: No
• Device Age: 0 YR
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/13/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/09/2017
• Supplement Report FDA Received Date: 06/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1