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	Therapeutic Response, Decreased (2271)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The date of the injection (implant/event date), follow-up date, and patient identifier will not be reported by the physician.This injection procedure information was provided to cytophil, inc.As part of a post-market clinical follow-up (pmcf) study.The hospital's protocol for execution of the retrospective data collection/review, approved by their investigation review board (irb), stated the study sponsor (cytophil, inc.) is not to receive any patient personal identification information.Cytophil has concluded its complaint investigation.Cytophil is unable to definitively determine the root cause of the reported incident.The device status was reported as unknown and therefore could not be evaluated.It can be reasonably concluded any portion of the syringe not used for the injection procedure was discarded per standard medical practice once the injection was complete and is therefore not available for return.Product labeling and risk management contain appropriate information regarding insufficient correction and poor voice quality.A review of complaint records revealed seven (7) complaints where the patient reported similar outcomes post-injection and one (1) complaint for the effects of the implant not lasting long.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 or if it was an underlying condition (e.G., newly developed right sided vocal fold atrophy/bowing).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 in office percutaneous injection of renú voice into the left vocal fold lateral to the thyroarytenoid muscle at the level of the vocal process for left vocal fold paralysis, dysphagia, and dysphonia.No procedural complications or superficial injection were noted.During a follow-up appointment thirty-one (31) days post-injection, voice quality was noted as "moderately dysphonic", the left true vocal fold is immobile with moderate atrophy/bowing and the right true vocal fold has full abduction/adduction with mild atrophy/bowing.The patient reported his voice was good for two weeks and then deteriorated.The patient stated it was hard to speak and his voice was very breathy and "airy." the physician reported voice quality and the ability to increase voice volume were not improved by the injection procedure and the voice is now nearly back to baseline and hypophonic.Left sided vocal fold immobility and atrophy/bowing was present before injection with renú but right sided vocal fold atrophy/bowing developed after injection.The patient had a medialization thyroplasty performed after the renú injection (no injection date provided).The patient's voice has not improved since follow-up and is reported to be mildly dysphonic.(ref.(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: 10308191
• Report Number: 3007225376-2020-00011
• Device Sequence Number: 13655901
• Product Code: MIX
• UDI-Device Identifier: 00856509002294
• UDI-Public: (01)00856509002294(10)Z908-00081(17)210226
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121795
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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: 02/26/2021
• Device Model Number: 08-015-04-V04
• Device Catalogue Number: 08-015-04-V04
• Device Lot Number: Z908-00081
• 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: 77 YR
• Patient Weight: 63