MAUDE Adverse Event Report: GENZYME CORPORATION(RIDGEFIELD) SYNVISC ONE; MOZ

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Atrial Fibrillation (1729); No Code Available (3191)

Event Date 01/01/2016

Event Type  Injury  

Event Description

A fib or heart failure [atrial fibrillation].Flush [flushing].Case narrative: initial information received on 17-jul-2018 regarding an unsolicited valid serious case received from a patient from united states.This case involves an unknown age female patient who received treatment with hylan g-f 20, sodium hyaluronate (synvisc one) and cortisone and after unknown latency had flush and a fib or heart failure.The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.Concomitant medications included apixaban (eliquis), metoprolol, losartan and diltiazem hydrochloride (diltiazem xr).On an unknown date in 2016, the patient received intra articular hylan g-f 20, sodium hyaluronate injection, 1 df, once in left knee (indication: not provided).Patient had good luck with the product and wants to have it injected again.Patient was diagnosed with a fib and/or heart failure sometime in 2016, but she did not knew if it was before or after she received synvisc one.On an unknown date, patient received cortisone injections (dose, frequency and indication: not provided) that made her flush for a couple of days after the injections when she had them in the past.Patient had also received hylan g-f 20, sodium hyaluronate injection in 2017.No additional information was provided for this report.Final diagnosis was a fib or heart failure and flush.It was not reported if the patient received a corrective treatment.The patient outcome is reported as unknown for both events.Seriousness criteria: medically significant for a-fib or heart failure a pharmaceutical technical complaint (ptc) was initiated on 25-jul-2018 for synvisc one with global ptc number: (b)(4).The product lot number was not provided; therefore a batch record review was not possible.Based on the lack of information provided, no capa was required.It was the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result was identified and mitigated through the ncr process.Sanofi global pharmacovigilance and epidemiology continuously monitored adverse event reports with or without lot numbers and assessed possible associations with their corresponding product lot, as part of routine safety surveillance effort to detect safety signals.This review had not indicated any safety issue.Sanofi will continue to monitor adverse events to determine if a capa is required.Additional information was received on 25-jul-2018.Global ptc number and results were added.Text was amended accordingly.Follow up was received on 02-oct-2018.No new information was received.

• Brand Name: SYNVISC ONE
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield 07657
• Manufacturer (Section G): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield 07657
• Manufacturer Contact: darlene kadel ; 55 corporate drive, ms 55b-220; a; bridgewater 08807
• MDR Report Key: 8398218
• MDR Text Key: 138081608
• Report Number: 2246315-2018-00872
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 03/07/2019

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
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/07/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: DILTIAZEM XR (DILTIAZEM HYDROCHLORIDE),; ELIQUIS (APIXABAN),; LOSARTAN (LOSARTAN),; METOPROLOL (METOPROLOL),
• Patient Outcome(s): Other; Required Intervention