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  

Event Description

Dilated cardiomyopathy with ef 20-25% [dilated cardiomyopathy] ([dysrhythmias], [ejection fraction decreased]).Case narrative: initial information received on 14-dec-2020 regarding an unsolicited valid serious case received from physician via health authorities of united states under reference mw5097901.The case was linked with (b)(4) (first injection: right knee), (b)(4) (second injection: right 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) and family history 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 started taking intra-articular injection of hylan g-f 20, sodium hyaluronate in left knee (first injection) (with an unknown batch number, dose, frequency, strength) for arthritis.There will be no information available on the batch number for 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 and its symptoms were assessed as medically significant and the event was also life threatening.Action taken: no action taken.It was not reported if the patient received a corrective treatment.Outcome: unknown.A product technical complaint (ptc) was initiated on 14-dec-2020 for synvisc.Batch number: unknown; global ptc number: (b)(4).The product lot number was not provided; therefore, a batch record review was not possible.Based on lack of information provided, no capa (corrective and preventive action) was required.It was the requirement to review all finished batch records for specification conformation prior to release.Any out of specification result was identified and mitigated through the ncr (non-conformances report) process.Sanofi global pharmacovigilance and epidemiology would continuously monitor adverse event reports with or without lot numbers and assesses possible associations with their corresponding product lot, as part of routine surveillance effort to detect safety signals.This review did not indicate any safety issue.Sanofi would continue to monitor if a capa was required.Investigation complete date: 04-jan-2021.Follow up was received on 14-dec-2020 from healthcare professional.Global ptc number was added.Text amended accordingly.Additional information was received on 04-jan-2021 from other healthcare professional (genzyme event management group).Global ptc number and its results were added.Clinical course updated.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: 11115804
• MDR Text Key: 231579478
• Report Number: 2246315-2021-00003
• 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?: 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): Life Threatening; Other