MAUDE Adverse Event Report: CYTOPHIL, INC. RENU VOICE, 1.5CC; SYSTEM, VOCAL CORD MEDIALIZATION

Model Number	08-015-04-V04
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Injury (2348)
Date of Event	04/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient identifier will not be reported by the physician.This injection procedure information was provided to cytophil, inc.As part of a retrospective data collection/review for a post-market clinical follow-up (pmcf) study.The center's investigation review board (irb) requires patient personal identification information not be shared.No changes to the patient's voice have been reported in medical records since the reported second injection.It can be reasonably concluded the voice remains high pitched and difficult to project.The patient reported they "liked the improvement from past surgeries in terms of communication and reduced mucous sensation and throat clearing." the patient has a history of tonsil cancer and prior to surgery was undergoing radiation prior to surgery.Cytophil has concluded its complaint investigation.Cytophil is unable to definitively determine the root cause of the reported incident.The device was reported as discarded and was therefore unavailable for return and no retain samples were evaluated.Product labeling and risk management contain appropriate information regarding insufficient correction and poor voice quality.A review of complaint records revealed seven (7) additional complaints where the patient reported similar outcomes in post-injection, no trending has been identified.The results of cytophil's review of the pertinent renú voice device manufacturing records confirm the devices were manufactured in accordance with specifications.Each patient case is unique for required volume to achieve correction.It cannot be determined if the renú injection procedure/implant caused the reported outcome, if it was an underlying condition, the alternate injectable implant used, or radiation therapy.The event was not reported to cytophil when it occurred.The physician is to be counseled about reporting complaints and adverse events to cytophil.The complaint is being closed and will be tracked and trended.
Event or Problem Description
The patient underwent an uneventful operating room (or) transoral injection of renú voice into both the left and right vocal folds on (b)(6) 2019 for right vocal fold paralysis, profound dysphagia, and left vocal fold atrophy using a renú transoral needle.0.3 cc of product was injected into the right vocal fold and 0.5 cc injected into the left vocal fold.No procedural complications were noted.A second transoral injection in the or was noted as performed (b)(6) 2019 using prolaryn gel and renú voice injected into the posterior pharyngeal wall.The second injection occurred because the left vocal fold appeared un-augmented.During a follow-up appointment post this second reported injection on (b)(6) 2020 the physician reported the patient's voice was noted as being high-pitched and difficult to project.The patient reported it is effortful to speak and his voice fatigues/gives out the more he talks.No pain or discomfort were reported.The patient has a history of tonsil cancer.((b)(4)).

• Brand Name: RENU VOICE, 1.5CC
• Common Device Name: SYSTEM, VOCAL CORD MEDIALIZATION
• Manufacturer (Section D): CYTOPHIL, INC.; 2485 corporate circle; suite 2; east troy, wi
• MDR Report Key: 10311995
• Report Number: 3007225376-2020-00006
• Device Sequence Number: 3376637
• Product Code: MIX
• UDI-Device Identifier: 00856509002294
• UDI-Public: (01)00856509002294(10)Z808-00050(17)200207
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121795
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/22/2020

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 Expiration Date: 02/07/2020
• Device Model Number: 08-015-04-V04
• Device Catalogue Number: 08-015-04-V04
• Device Lot Number: Z808-00050
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2020
• Initial Report FDA Received Date: 07/22/2020
• 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: Other
• Patient Age: 72 YR
• Patient Weight: 79