MAUDE Adverse Event Report: ANIKA THERAPEUTICS ORTHOVISC; 2 ML, 15 MG/ML HIGH MOLECULAR WEIGHT HYALURONAN

Model Number	630-254
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/17/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
In pma# part of this report the combination box was checked when i reached the page.I was unable to un-check the box.Orthovisc is not a combination product.
Event or Problem Description
"depuy mitek quality department received a medwatch form from the spine group on 8-28-2017 with the following event description.Received 3 rounds of orthovisc knee injections at (b)(6) 2016.Within one week, started having severe heart arrythmias.Had a previous history of arrythmia and svt, but my heart doctor said it was never consistent enough to treat it.After the knee injections, i visited my heart doctor with the increased symptoms.He wanted me to wear a heart monitor for one month.After one week, his office called and said they had all the info they needed, had me return to his office and scheduled a heart ablation for 3 months out.Heart ablation happened in (b)(6) and was unsuccessful.Three and a half months later, i had a stroke on (b)(6) and was hospitalized for 4 days.All tests came back negative for any explanations.As of yet, there is no explanation for my stroke.I am (b)(6), not overweight and in pretty good health.I exercise 3 times a week.I am on blood pressure daily for hypertension and it is well controlled.I still have to f/u with my pcp and neurologist next week, at which time i will discuss the possible link between the orthovisc injection and my stroke.I just had such a huge health change with my heart within days of getting the orthovisc injections, that i truly believe that this is all related to that.I did mention it to my heart doctor and of course he just noted it and would not discuss it with me.There must be some code of ethics between doctors that keeps them from doing that.I will get to the bottom of it, unless it kills me first.Injected in the knee joint, once weekly/3 wks.Dates of use (b)(6) 2016.Osteo arthritis in the knees.Lisinopril / hctz 20/12.5, 425 mg aspirin daily - post stroke.".

• Brand Name: ORTHOVISC
• Common Device Name: 2 ML, 15 MG/ML HIGH MOLECULAR WEIGHT HYALURONAN
• Manufacturer (Section D): ANIKA THERAPEUTICS; 32 wiggins ave; bedford MA 01730
• MDR Report Key: 6888476
• Report Number: 3007093114-2017-00019
• Device Sequence Number: 10962652
• Product Code: MOZ
• UDI-Device Identifier: 10886705023110
• UDI-Public: 10886705023110
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/22/2017

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: No Information
• Device Model Number: 630-254
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2017
• Initial Report FDA Received Date: 09/22/2017
• 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: Hospitalization