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

Lot Number UNKNOWN

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

Patient Problems Arrhythmia (1721); Cardiomyopathy (1764); No Code Available (3191)

Event Date 01/01/1999

Event Type  Injury  

Manufacturer Narrative

Sanofi company comment dated 04-jan-2021: this case concerns a patient who was on treatment with synvisc and reported to have life threatening dilated cardiomyopathy with ef 20-25%, asymptomatic dysrhythmia.The information in the case is very limited.Therefore, the causality with the device could not be completely denied.Further, detailed information regarding onset latency, concomitant medications, relevant medical history and family history and full clinical course of the event would aid in better assessment of the case.

Event Description

Dilated cardiomyopathy with ef 20-25% [dilated cardiomyopathy] ([ejection fraction decreased], [dysrhythmias]).Case narrative: initial information was received on (b)(6) 2020 regarding an unsolicited valid serious case from a physician via health authorities of united states under reference mw5097901.The case was linked with (b)(4) (first injection: right knee), (b)(4) (first injection: left knee), (b)(4) (second injection: left knee), (b)(4) (third injection: right knee) and (b)(4) (third injection: left knee) (multiple devices for same patient).This case involves an unknown age female patient who had dilated cardiomyopathy with ef 20-25%, while she was treated with hylan g-f 20, sodium hyaluronate (synvisc).The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided.It was reported that patient was previously well with exception of arthritis (ongoing condition).On an unknown date in 1999, the patient received intra-articular injection of hylan g-f 20, sodium hyaluronate in right knee for arthritis (second injection) (with an unknown batch number, dose, and frequency).There would be no information available on the batch number of this case.On an unknown date in 1999, on routine exam patient was found to have an asymptomatic dysrhythmia (arrhythmia).Patient had stress echo, holter and ultimately cardiac cath (catherization) was done.No cad (coronary artery disease) was found.Finding showed dilated cardiomyopathy with ef (ejection fraction) 20-25% (congestive cardiomyopathy with symptom of ejection fraction decreased) (onset: 1999, latency: unknown).Event of congestive cardiomyopathy was assessed as medically significant and life threatening.Action taken: no action taken.Corrective treatment: not reported.Outcome: unknown.Product technical complaint (ptc) was initiated with global ptc number (b)(4) on 14-dec-2020 for product.Batch number; unknown.Device not returned.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 report) 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 had not indicated any safety issue.Sanofi will continue to monitor adverse events to determine if a capa is required.Final investigation complete date: (b)(6) 2021.Follow up information was received on 14-dec-2020 from other healthcare professional.Global ptc number was added.No significant information was received.Additional information was received on 04-jan-2021 from healthcare professional.Global ptc results added.Text was 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: 11115803
• MDR Text Key: 230127400
• Report Number: 2246315-2021-00004
• 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: health professional
• Type of Report: Initial
• Report Date: 01/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No
• 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): Life Threatening; Other