MAUDE Adverse Event Report: ANIKA THERAPEUTICS INC ORTHOVISC; SODIUM HYALURONATE FOR INTRA- ARTICULAR INJECTION

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Thyroid Problems (2102); Vertigo (2134); Dizziness (2194)
Date of Event	08/06/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
"this spontaneous report from the united states was reported by consumer and concern (b)(6) years old caucasian female who experience thyroid cancer, swallowing difficulties, ringing in her ears, coughing profusely, dizziness, vertigo, terrible reaction to orthovisc, triglycerides increase and underdose, coincident with vascepa.In 2016 ( reported as three years ago) the patient initiated vascepa, 2 capsules twice daily, oral for hypertriglyceridemia.In 2018 ( reported as one year ago) the dose was reduced to 1 capsule twice daily.(current lot number 7k02784 and expiration date sep 2021).It was not reported whether the dose reduction was initiated by the patient of the physician.Medical history was relevant for arthritis and high cholesterol.Concomitant medication were crestor (rosuvastatin), rheumate, (folate, methylcobalamin, curcuminoid turmerone complex), celebrex (celecoxib), tizanidine and gelsyn (hydraulic acid.She has an allergy to tetracycline.She is a non-smoker and drinks red wine 4-5 times a week.In (b)(6) 2019, the patient experienced swallowing difficulties, ringing in her ears, coughing profusely, dizziness, vertigo and high blood pressure.A biopsy in her thyroid was performed and in (b)(6) 2019 she was diagnose with thyroid cancer.She was told a mutation in her genes was causing the cancer.On (b)(6) 2019, a thyroidectomy was performed.She was scheduled to have a radioactive iodine treatment in the near future.During this time, her blood pressure was treated with medication.However, the blood pressure problem went away after she had her thyroid removed.In about (b)(6) 2018, she received an orthovisc (hyalauric acid) injection for her knee, which she had a terrible reaction to.It made her knee ten times worse and she could not walk.On an unknown date she was taken of versapa and other medication for a test or procedure and during that time her triglycerides increases from 200-502.They increased again after she restarted vascepa.At the time of the report, the status of vascepa was continued and the outcome of the event of the thyroid cancer was recovering.The outcome of the event of swallowing difficulties, ringing in ears, coughing profusely, dizziness, vertigo, adverse reaction and underdose was unknown.The outcome of triglycerides increases was recovered.Orthovisc was considered co suspect for the adverse reaction.Company comment; this case is not medically confirmed, spontaneous report of serious event of thyroid cancer and non-serious event of dysphagia, tinnitus, cough, dizziness, vertigo, adverse reaction, blood triglycerides increase and underdose.These events are not labelled.The company considers serious event of thyroid cancer as not related to vascepa.Unspecified genetic mutation mentioned in report provides more plausible etiology.Furthermore, treatment with vascepa was discontinued.The company considers remaining events of dysphagia, tinnitus, cough, dizziness, vertigo, adverse event, blood triglycerides increase and underdose as not related to vascepa.Dysphagia and cough are common symptoms of thyroid cancer.Increase of triglycerides is consequence of interruption of vascepa, level decrease after restarting vascepa.Adverse reaction is related to orthovisc.Underdose is not assessed.".

• Brand Name: ORTHOVISC
• Common Device Name: SODIUM HYALURONATE FOR INTRA- ARTICULAR INJECTION
• Manufacturer (Section D): ANIKA THERAPEUTICS INC; 32 wiggins ave; bedford MA 01730
• MDR Report Key: 9121464
• Report Number: 3007093114-2019-00008
• Device Sequence Number: 13903480
• Product Code: MOZ
• UDI-Device Identifier: 10886705023110
• UDI-Public: 10886705023110
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P030019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/24/2019
• 2 Devices were Involved in the Event: 1 2

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/28/2019
• Initial Report FDA Received Date: 09/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Weight: 63