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

Lot Number DRSP003

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

Patient Problem Arthritis (1723)

Event Type  Injury  

Event Description

Acute on chronic inflammation [injection site joint inflammation] ([injection site joint effusion], [joint aspiration], [injection site joint pain], [condition aggravated], [c-reactive protein increased], [red blood cell sedimentation rate increased]).Vomiting [vomiting].Nausea [nausea].Low grade temps [low grade fever].Received synvisc for chondral flare with no reported adverse event [product use in unapproved indication].Received synvisc for chondral flare with no reported adverse event [off label use of device].Case narrative: initial information was received from united states on 14-dec-2023 regarding an unsolicited valid serious case from other health professional.This case involves an unknown age female patient who had acute on chronic inflammation, vomiting, nausea, and low grade temps (temperature) after the use of medical device hylan g-f 20, sodium hyaluronate [synvisc].Also, patient received synvisc for chondral flare with no adverse event reported directly linked to this product use in unapproved indication and off label use of device.She had multiple allergies and sensitivities but none that would red flag viscosupplementation.She was not allergic to hyaluronic acid nor poultry proteins.Past medical history included ms (multiple sclerosis) and psoriatic arthritis, no plaques noted over knees.She was not treated for her psoriatic arthritis nor did she saw rheumatology and she noted her symptoms are more in her hands.The patient was status post (s/p) arthroscopy for chondral flare and was recommended to undergo viscosupplementation.The patient's past medical treatment(s), vaccination(s), concomitant medication, and family history were not provided.On an unknown date, the patient received 2nd synvisc (hylan g-f 20, sodium hyaluronate, 16 mg/2ml) injection of series for viscosupplementation at dose of 2 ml in left knee (lot number, expiry date, frequency, route - unknown) for chondral flare.Information on batch number was requested.On an unknown date, after unknown latency, after the second injection pain increased significantly with knee effusion (injection site joint pain, condition aggravated, injection site joint effusion, was leading to intervention).She was aspirated twice (aspiration joint, was leading to intervention) and cultures were negative for bacteria.She was taken back to the or (operation room) for arthroscopy with irrigation and debridement and multiple samples sent and no growth for bacteria, fugal and pathology showed mark acute on chronic inflammation (injection site joint inflammation, onset date and latency: unknown, was leading to intervention).On an unknown date, after unknown latency, labs did not show an elevated white count but her crp and esr were significantly elevated (c-reactive protein increased, red blood cell sedimentation rate increased, was leading to intervention).On an unknown date, after unknown latency, she also developed systemic symptoms such as nausea/vomiting, and low-grade temps (pyrexia).She continued to have significant knee pain (injection site joint inflammation, was leading to intervention) and moderate effusions (injection site joint effusion, was leading to intervention).Reporter had not noted on the fda website any recalls recently.However, was asking if there were any other cases of such a severe reaction/response after these injections.She would be seen in hospital on 15-dec-2023 for evaluation.Action taken: not applicable for product use in unapproved indication and off label use of device, drug withdrawn for rest all events corrective treatment: aspirated twice, arthroscopy with irrigation and debridement for acute on chronic inflammation).It was not reported if the patient received a corrective treatment for the events (nausea, vomiting, low grade temps).At time of reporting, the outcome was unknown for product use in unapproved indication and off label use of device, not recovered for rest all events.

Manufacturer Narrative

Sanofi company comment dated 21-dec-2023: this case involves an unknown age female patient who had acute on chronic inflammation, vomiting, nausea, and low grade temps (temperature) after the use of medical device hylan g-f 20, sodium hyaluronate [synvisc] for chondral flare (product use in unapproved indication and off label use of device).Based on the available information, causal relationship between the events and suspect product could not be denied.Role of patient¿s medical history of multiple allergies and sensitivities and chondral flare could not be overlooked as well in occurrence of reported events.However, further information regarding patient¿s concomitant medications, and other risk factors would aid in better case assessment.

Event Description

Acute on chronic inflammation [injection site joint inflammation] ([injection site joint effusion], [joint aspiration], [injection site joint pain], [condition aggravated], [c-reactive protein increased], [red blood cell sedimentation rate increased]) vomiting [vomiting] nausea [nausea] low grade temps [low grade fever] received synvisc for chondral flare with no reported adverse event [product use in unapproved indication] received synvisc for chondral flare with no reported adverse event [off label use of device] case narrative: initial information was received from united states on 14-dec-2023 regarding an unsolicited valid serious case from other health professional.This case involves an unknown age female patient who had acute on chronic inflammation, vomiting, nausea, and low grade temps (temperature) after the use of medical device hylan g-f 20, sodium hyaluronate [synvisc].Also, patient received synvisc for chondral flare with no adverse event reported directly linked to this product use in unapproved indication and off label use of device.She had multiple allergies and sensitivities but none that would red flag viscosupplementation.She was not allergic to hyaluronic acid nor poultry proteins.Past medical history included ms (multiple sclerosis) and psoriatic arthritis, no plaques noted over knees.She was not treated for her psoriatic arthritis nor did she saw rheumatology and she noted her symptoms are more in her hands.The patient was status post (s/p) arthroscopy for chondral flare and was recommended to undergo viscosupplementation.The patient's past medical treatment(s), vaccination(s), concomitant medication, and family history were not provided.On an unknown date, the patient received 2nd synvisc (hylan g-f 20, sodium hyaluronate, 16 mg/2ml) injection of series for viscosupplementation at dose of 2 ml in left knee (expiry date, frequency, route: unknown and batch number: drsp003) for chondral flare.Information on batch number was requested.On an unknown date, after unknown latency, after the second injection pain increased significantly with knee effusion (injection site joint pain, condition aggravated, injection site joint effusion, was leading to intervention).She was aspirated twice (aspiration joint, was leading to intervention) and cultures were negative for bacteria.She was taken back to the or (operation room) for arthroscopy with irrigation and debridement and multiple samples sent and no growth for bacteria, fugal and pathology showed mark acute on chronic inflammation (injection site joint inflammation, onset date and latency: unknown, was leading to intervention).On an unknown date, after unknown latency, labs did not show an elevated white count but her crp and esr were significantly elevated (c-reactive protein increased, red blood cell sedimentation rate increased, was leading to intervention).On an unknown date, after unknown latency, she also developed systemic symptoms such as nausea/vomiting, and low-grade temps (pyrexia).She continued to have significant knee pain (injection site joint inflammation, was leading to intervention) and moderate effusions (injection site joint effusion, was leading to intervention).Reporter had not noted on the fda website any recalls recently.However, was asking if there were any other cases of such a severe reaction/response after these injections.She would be seen in hospital on (b)(6) 2023 for evaluation.Action taken: not applicable for product use in unapproved indication and off label use of device, drug withdrawn for rest all events corrective treatment: aspirated twice, arthroscopy with irrigation and debridement for acute on chronic inflammation).It was not reported if the patient received a corrective treatment for the events (nausea, vomiting, low grade temps).At time of reporting, the outcome was unknown for product use in unapproved indication and off label use of device, not recovered for rest all events a product technical complaint (ptc) was initiated on (b)(6) 2023 for synvisc (hylan g-f 20, sodium hyaluronate) (batch number: drsp003) with global ptc number: (b)(4) the sample was not available and ptc was set in process.Additional information was received on 26-dec-2023 from quality department: ptc details with global ptc number and suspect batch number added.Text was amended accordingly.

Event Description

Acute on chronic inflammation [injection site joint inflammation] ([injection site joint effusion], [joint aspiration], [injection site joint pain], [condition aggravated], [c-reactive protein increased], [red blood cell sedimentation rate increased]), vomiting [vomiting], nausea [nausea], low grade temps [low grade fever], received synvisc for chondral flare with no reported adverse event [product use in unapproved indication], received synvisc for chondral flare with no reported adverse event [off label use of device].Case narrative: initial information was received from united states on 14-dec-2023 regarding an unsolicited valid serious case from other health professional.This case involves an unknown age female patient who had acute on chronic inflammation, vomiting, nausea, and low grade temps (temperature) after the use of medical device hylan g-f 20, sodium hyaluronate [synvisc].Also, patient received synvisc for chondral flare with no adverse event reported directly linked to this product use in unapproved indication and off label use of device.She had multiple allergies and sensitivities but none that would red flag viscosupplementation.She was not allergic to hyaluronic acid nor poultry proteins.Past medical history included ms (multiple sclerosis) and psoriatic arthritis, no plaques noted over knees.She was not treated for her psoriatic arthritis nor did she saw rheumatology and she noted her symptoms are more in her hands.The patient was status post (s/p) arthroscopy for chondral flare and was recommended to undergo viscosupplementation.The patient's past medical treatment(s), vaccination(s), concomitant medication, and family history were not provided.On an unknown date, the patient received 2nd synvisc (hylan g-f 20, sodium hyaluronate, 16 mg/2ml) injection of series for viscosupplementation at dose of 2 ml in left knee (frequency, route: unknown; batch number: drsp003, expiry date: 28-feb-2026) for chondral flare.Information on batch number was requested.On an unknown date, after unknown latency, after the second injection pain increased significantly with knee effusion (injection site joint pain, condition aggravated, injection site joint effusion, was leading to intervention).She was aspirated twice (aspiration joint, was leading to intervention) and cultures were negative for bacteria.She was taken back to the or (operation room) for arthroscopy with irrigation and debridement and multiple samples sent and no growth for bacteria, fugal and pathology showed mark acute on chronic inflammation (injection site joint inflammation, onset date and latency: unknown, was leading to intervention).On an unknown date, after unknown latency, labs did not show an elevated white count but her crp and esr were significantly elevated (c-reactive protein increased, red blood cell sedimentation rate increased, was leading to intervention).On an unknown date, after unknown latency, she also developed systemic symptoms such as nausea/vomiting, and low-grade temps (pyrexia).She continued to have significant knee pain (injection site joint inflammation, was leading to intervention) and moderate effusions (injection site joint effusion, was leading to intervention).Reporter had not noted on the fda website any recalls recently.However, was asking if there were any other cases of such a severe reaction/response after these injections.She would be seen in hospital on (b)(6) 2023 for evaluation.Action taken: not applicable for product use in unapproved indication and off label use of device, drug withdrawn for rest all events.Corrective treatment: aspirated twice, arthroscopy with irrigation and debridement for acute on chronic inflammation).It was not reported if the patient received a corrective treatment for the events (nausea, vomiting, low grade temps).At time of reporting, the outcome was unknown for product use in unapproved indication and off label use of device, not recovered for rest all events.A product technical complaint (ptc) was initiated on 14-dec-2023 for synvisc (hylan g-f 20, sodium hyaluronate) (batch number: drsp003 and expiry date: 28-feb-2026) with global ptc number: (b)(4).The sample was of ptc not available and ptc stated: preliminary assessment: based on the complaint from intake team, there is no quality related defect that would attribute to a malfunction a death or serious injury.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.The defect class has been updated to ii - (b)(6) 15dec2023).Investigation: (b)(6) 03jan2024).Batch number: drsp003, synvisc was manufactured on 06mar2023 with expiration date of 28feb2026 yielding (b)(4) kits.The incoming component inspection, packaging, and quality control documentation for this lot was reviewed.The investigation showed the product met specification at the time of release.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 nonconforming material or product process.Furthermore, no associated non-conformance's were noted for the issue defect at time of release.Trend analysis: there are two (2) complaints for mother lot: drsp003 and sub-batches.100347222 drsp003 syringe luer lock system damaged 100357007 drsp003 syringe broken while use based on investigation and trend analysis, no capa required.Sanofi will continue to monitor adverse events.Trend analysis will be performed on a periodic basis product event handling to determine if a capa (corrective and preventive action) is required.There is no quality related defect that would attribute to a malfunction, death, or serious injury.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.The final investigation was completed on 04-jan-2024 with summarized conclusion as no assessment possible.Additional information was received on 26-dec-2023 from quality department: ptc details with global ptc number and suspect batch number added.Text was amended accordingly.Additional information was received on 04-jan-2024 from quality department: ptc details with summarized conclusion and suspect expiry date 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: 18390460
• MDR Text Key: 331319914
• Report Number: 2246315-2023-00117
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Followup,Followup
• Report Date: 01/08/2024

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: Health Professional
• Device Lot Number: DRSP003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/25/2023
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/01/2024; 01/08/2024
• 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
• Patient Sex: Female