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 Codes	Dyspnea (1816); Edema (1820)
Date of Event	05/14/2019
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.The post vocal fold injection edema mostly resolved as of (b)(6) 2019 and the patient was discharged from the hospital (b)(6) 2019.The patient was reported to still have mild dyspnea on (b)(6) 2019 and was undergoing chemotherapy for metastatic small cell carcinoma in the left lung both before and after injection.No locations beyond the left lung were reported for the metastasized cancer.The patient's voice is noted as having a "gravelly" quality but notes intermittent external neck swelling has resolved.Patient was reported to have sought voice therapy after follow-up appointment.Patient is now deceased.The renú injection was confirmed to be unrelated to the patient's death.The device lot number used for injection was not reported but a review of distribution records can conclude the most likely renú voice lot used in the injection was z908-00076.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 edema of the larynx (swelling of throat), airway compromise, and breathing difficulty.There are no other noted complaints for edema of the larynx and dyspnea.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.The physician treated the patient with steroids for the swelling as recommended by the renú voice ifu.It cannot be determined if the renú injection procedure/implant caused the reported outcome, if it was the active cancer, or on-going chemotherapy treatment.The renú voice ifu states renú is "contraindicated in the presence of foreign bodies, acute inflammation, infection, inadequately controlled malignancy or rapidly advancing disease when these involve the larynx or upper respiratory tract." it was not reported if the cancer metastasized to the upper respiratory tract.The event was not reported to cytophil when it occurred in (b)(6) 2019.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) injection of 0.7ml of renú voice into the posterolateral aspect of the left vocal fold on (b)(6) 2019 for left true vocal fold paralysis and dysphonia.No procedural complications were noted and the patient's voice was reported to be "audibly louder and stronger" post-injection.Severe swelling (edema of the larynx) with dyspnea was noted on (b)(6) 2019 and the patient treated with 8mg of intravenous steroids (dexamethasone (decadron)) in the hospital for two (2) days.The patient was discharged (b)(6) 2019.During a follow-up appointment on (b)(6) 2019 the swelling was noted to improve with the steroid treatment.((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: 10312068
• Report Number: 3007225376-2020-00003
• Device Sequence Number: 3376640
• Product Code: MIX
• UDI-Device Identifier: 00856509002294
• UDI-Public: (01)00856509002294(10)Z908-00076(17)210216
• 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: 02/16/2021
• Device Model Number: 08-015-04-V04
• Device Catalogue Number: 08-015-04-V04
• Device Lot Number: Z908-00076
• 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: 76 YR
• Patient Weight: 60