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

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

Patient Problem Atrial Fibrillation (1729)

Event Date 04/29/2022

Event Type  Injury  

Event Description

Atrial fibrillation [atrial fibrillation].Case narrative: initial information was received from united states on 23-may-2022 regarding an unsolicited valid serious case from a consumer/non-health-care professional.This case involves an adult patient (unknown gender) who experienced atrial fibrillation while being treated with hylan g-f 20, sodium hyaluronate [synvisc].The patient's past medical treatment(s), vaccination(s) and family history were not provided.It was unknown if the patient had any medical history, concomitant disease, or risk factor.On an unknown date, the patient started taking synvisc (hylan g-f 20, sodium hyaluronate, 8 mg/ml, pre-filled syringe 3x2ml) injection via intraarticular route (with an unknown batch number, dose, frequency, expiry date, indication).Information on batch number was requested.On an unknown date the patient was diagnosed with atrial fibrillation (unknown latency) following the first dose intake of hylan g-f 20 and sodium hyaluronate.This event was assessed as medically significant.It was unknown if the patient experienced any additional symptoms/events.It was unknown if there were lab data/results available.Action taken: unknown.It was not reported if the patient received a corrective treatment for the event (atrial fibrillation).At time of reporting, the outcome was not recovered for the event atrial fibrillation.A product technical complaint (ptc) was initiated, and the results were pending for the same.

Event Description

Atrial fibrillation [atrial fibrillation] case narrative: initial information was received from united states on 23-may-2022 regarding an unsolicited valid serious case from a consumer/non-health-care professional.This case involves an adult patient (unknown gender) who experienced atrial fibrillation while being treated with hylan g-f 20, sodium hyaluronate [synvisc].The patient's past medical treatment(s), vaccination(s) and family history were not provided.It was unknown if the patient had any medical history, concomitant disease, or risk factor.On an unknown date, the patient started taking synvisc (hylan g-f 20, sodium hyaluronate, 8 mg/ml, pre-filled syringe 3x2ml) injection, liquid (solution) via intraarticular route (with an unknown batch number, dose, frequency, expiry date, indication).Information on batch number was requested.On an unknown date the patient was diagnosed with atrial fibrillation (unknown latency) following the first dose intake of hylan g-f 20 and sodium hyaluronate.This event was assessed as medically significant.It was unknown if the patient experienced any additional symptoms/events.It was unknown if there were lab data/results available.Action taken: unknown.It was not reported if the patient received a corrective treatment for the event (atrial fibrillation).At time of reporting, the outcome was not recovered for the event atrial fibrillation.A product technical complaint (ptc) was initiated on 01-jun-2022 for synvisc with global ptc number (b)(4) (batch: unknown).The product lot number was not provided; therefore, a batch record review is not possible.Based on the lack of information provided, no capa is required.It is the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result is identified and mitigated through the ncr process.Sanofi global pharmacovigilance and epidemiology continuously monitors adverse event reports with or without lot numbers, and assesses possible associations with their corresponding product lot, as part of routine safety surveillance effort to detect safety signals.This review has not indicated any safety issue.Sanofi will continue to monitor adverse events to determine if a capa is required.The final investigation was completed on 08-jul-2022 and investigation conclusion was no assessment possible.Additional information was received on 23-may-2022 and 01-jun-2022 from the quality department and processed with clock start date of 23-may-2022.Global ptc number added.No significant information added.Additional information received on 08-jul-2022 from quality department.Suspect formulation updated.Ptc results added.Text amended accordingly.

Event Description

Atrial fibrillation [atrial fibrillation] case narrative: initial information was received from patient on 23-may-2022 regarding an unsolicited valid serious case from health authorities of united states under reference mw5109479.This case is cross linked to the case (b)(4) (duplicate case) this case involves an adult patient (unknown gender) who experienced atrial fibrillation while being treated with hylan g-f 20, sodium hyaluronate [synvisc].The patient's past medical treatment(s), vaccination(s) and family history were not provided.It was unknown if the patient had any medical history, concomitant disease, or risk factor.On an unknown date, the patient started taking synvisc (hylan g-f 20, sodium hyaluronate, 8 mg/ml, pre-filled syringe 3x2ml) injection, liquid (solution) at a dose of 2ml frequency: 3x via intraarticular route (with an unknown batch number, dose, frequency, expiry date, indication).Information on batch number was requested.On ( b)(6) 2022 after unknown latency the patient was diagnosed with atrial fibrillation (medically significant).It was unknown if the patient experienced any additional symptoms/events.It was unknown if there were lab data/results available.Action taken: unknown.It was not reported if the patient received a corrective treatment for the event (atrial fibrillation).At time of reporting, the outcome was not recovered for the event atrial fibrillation.A product technical complaint (ptc) was initiated on 01-jun-2022 for synvisc with global ptc number 100231295 (batch: unknown).The sample status was not available the product lot number was not provided; therefore, a batch record review was not possible.Based on the lack of information provided, no capa (corrective and preventive action) 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 (non-conformance) process.Sanofi global pharmacovigilance and epidemiology continuously monitors adverse event reports with or without lot numbers, and assesses possible associations with their corresponding product lot, as part of routine safety surveillance effort to detect safety signals.This review has not indicated any safety issue.Sanofi would continue to monitor adverse events to determine if a capa was required.The final investigation was completed on 08-jul-2022 and investigation conclusion was no assessment possible.Additional information was received on 23-may-2022 and 01-jun-2022 from the quality department and processed with clock start date of 23-may-2022.Global ptc number added.No significant information added.Additional information received on 08-jul-2022 from quality department.Suspect formulation updated.Ptc results added.Text amended accordingly.Upon internal review the case (b)(4) (be deleted) was identified to be duplicate of (b)(4) (to be retained).Hence, all the information from the case (b)(4) (to be deleted) has been merged in case (b)(4) (to be retained).The case (b)(4) received with clock start date of (b)(6) 2022 will be deleted.Additional case id added.Event onset added.Text amended accordingly.

• Brand Name: SYNVISC
• 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: heather schiappacasse ; 55 corporate drive, ms 55b-220; a; bridgewater 08807
• MDR Report Key: 14599198
• MDR Text Key: 293338042
• Report Number: 2246315-2022-00051
• 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,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/18/2023

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/04/2022
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 07/14/2022; 06/18/2023
• 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
• Patient Outcome(s): Required Intervention; Other