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	Muscular Rigidity (1968)
Date of Event	09/11/2018
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.The physician reported the implant may have partially resorbed early.It is possible but cannot be definitively determined if the implant partially extruded post injection due to the reported coughing.The physician reported being unsure if the vocal fold stiffness was a result of the injection.The cause of the vocal fold stiffness cannot be definitively be determined as this could be related to the implant, the injection procedure, on-going chemotherapy, or the patient's thyroid cancer.The device was reported as discarded and was therefore unavailable for return and no retain samples were evaluated.The review of the pertinent renú voice device manufacturing records confirms the devices were manufactured in accordance with specifications.Product labeling and risk management contain appropriate information regarding contraindications, extrusion, ineffective treatment, poor voice quality, and premature absorption.No corrective actions are necessary, and the product can be used as is.There were two (2) similar complaints for vocal fold stiffness and one (1) for possible premature absorption.No trending was identified.Cytophil has concluded its complaint investigation.Cytophil is unable to definitively determine the root cause of the reported incident.The results of cytophil's review of the pertinent renú voice device manufacturing records confirm the devices were manufactured in accordance with specifications.Each case is unique for required volume to achieve correction.It cannot be determined if the renú injection procedure/implant caused the reported outcome, on-going chemotherapy, or the patient's thyroid cancer, although it is possible the patient's coughing may have caused some of the implant to extrude post-injection resulting in the "partially resorbed" observation.The event was not reported to cytophil when it occurred but rather through a pmcf study.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 1.0ml of renú voice into the posterolateral left vocal fold on (b)(6) 2018 for left true vocal fold paralysis, dysphonia, and dysphagia.No procedural complications were noted but severe coughing after extubation was reported, which resolved.During a follow-up appointment on (b)(6) 2018, immobility of the vocal fold was noted and thyroid cancer determined to be the most likely cause.Hypomobility of the right true vocal fold as well as stiffness in the vocal folds were also noted.The physician was unsure if the implant partially resorbed prematurely or may be causing the vocal fold stiffness.(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: 10312036
• Report Number: 3007225376-2020-00004
• Device Sequence Number: 3376639
• Product Code: MIX
• UDI-Device Identifier: 00856509002294
• UDI-Public: (01)00856509002294(10)R808-00060(17)200523
• 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: 2018
• 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: 05/23/2020
• Device Model Number: 08-015-04-V04
• Device Catalogue Number: 08-015-04-V04
• Device Lot Number: R808-00060
• 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: 64