MAUDE Adverse Event Report: ATOS MEDICAL AB PROVOX2; VOICE PROSTHESIS

Catalog Number	7217
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Necrosis (1971); Tissue Damage (2104)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation: no device was available for investigation.Users story: first vp change after 23 months, provox2 8mm.Changed due to periprosthetic leak (leakage around the vp).Second vp change after 26 months, provox2 8mm.Changed due to periprosthetic leak.Third vp change after 12 months.Changed due to periprosthetic leakage.This time a provox2 6mm was placed.After 7 months the too short vp caused necrosis to the party wall.In the instructions for use we describe how to decide on vp lengths.Conclusion: based on the user story in the case report, atos medical ab believes it is clear that this adverse advent does not originated from a faulty product.
Event or Problem Description
This is the information that was received from the initial reporter: clinical affairs within atos medical ab did an expanded search during regular cer update and found a case study in india regarding provox2.The case study was about a patient that had a too short prosthesis fitted, which resulted in pressure necrosis of the part wall and mucosa between the flanges.Case study: anam jr, kannan s, chaukar da, d'cruz a k.A rare case of tracheoesophageal puncture with party wall necrosis.Indian j cancer.2015 jul-sep;52(3):303-4.Intended use and description of the product: the provox 2 voice rehabilitation system is intended for use in surgical, prosthetic voice restoration after total laryngectomy.The prosthesis may be inserted by the physician at the time of the total laryngectomy (primary puncture), or at a later date (secondary puncture), or may be used to replace the present prosthesis.The provox2 voice prosthesis is a sterile single use one-way valve that keeps a te-puncture open for speech, while reducing the risk of fluids and food entering the trachea.It is made of medical grade silicone rubber and radio-opaque fluoroplastic.The prosthesis is not a permanent implant and needs periodic replacement.

• Brand Name: PROVOX2
• Common Device Name: VOICE PROSTHESIS
• Manufacturer (Section D): ATOS MEDICAL AB; kraftgatan 8, p.o. box 183; hörby, 24222 ; SW 24222
• MDR Report Key: 9841209
• Report Number: 8032044-2020-00002
• Device Sequence Number: 743356
• Product Code: EWL
• UDI-Device Identifier: 07331791010033
• UDI-Public: 7331791010033
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K971244
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/20/2020

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: 7217
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2020
• Initial Report FDA Received Date: 03/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention