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] ([ejection fraction decreased], [dysrhythmias]).Case narrative: the case was linked with (b)(4) (first injection: left 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).Initial information received on (b)(6) 2020 regarding an unsolicited valid serious case received from physician via health authorities of united states under reference mw5097901.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 right 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 (b)(6) 2020 for synvisc for unknown batch number and global ptc number: (b)(4).The product lot number was not provided; therefore, a batch record review was not possible.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-conformances report) process.Adverse event reports with or without lot numbers were continuously monitored, and possible associations with their corresponding product lot are assessed, as part of routine safety surveillance effort to detect safety signals.This review had not indicated any safety issue.Sanofi would continue to monitor adverse events to determine if a capa (corrective and preventive action) was required.Investigation completion date: (b)(6) 2020.Follow up was received on (b)(6) 2020 from healthcare professional.Global ptc number added.Text amended accordingly.Additional information was received on (b)(6) 2020 from healthcare professional.Investigational results were 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: 11075311
• MDR Text Key: 229832593
• Report Number: 2246315-2020-00180
• 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: 12/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2020
• 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