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); Hyperglycemia (1905); High Blood Pressure/ Hypertension (1908); Viral Infection (2248); Diabetic Ketoacidosis (2364); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Sanofi company comment dated 09-jan-2023: this case involves a 75 years old female patient who had covid 19, diabetes, cardiac arrhythmia, high blood pressure and depression while being treated with medical device hylan g-f 20, sodium hyaluronate (synvisc).Based on the available information, causal relationship between the events and suspect product could not be established.Patient¿s advanced age could be considered as a major factor in occurrence of events- diabetes, cardiac arrhythmia, high blood pressure and depression.However, further information regarding onset latency, patient¿s medical history, past medications, concomitant medications, concurrent clinical presentation, and other risk factors would aid in better case assessment.

Event Description

Covid 19 [covid-19].Diabetes [diabetes].Cardiac arrhythmia [cardiac arrhythmia].High blood pressure [blood pressure high].Depression [depression].Case narrative: initial information was received on 03-jan-2023 regarding a solicited valid serious case from a consumer/non-hcp, in the scope of patient support program "psp_synvisc_prosane".Patient id: (b)(6).Study title: patient support program involving synvisc.This case involves a 75 years old female patient who had covid 19, diabetes, cardiac arrhythmia, high blood pressure and depression while being treated with medical device hylan g-f 20, sodium hyaluronate (synvisc).The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On an unknown date between 2020 and 2021, the patient started taking hylan g-f 20, sodium hyaluronate injection via intra-articular route (with an unknown batch number, expiry date, dose, frequency) for knee osteoarthritis.Information on batch number was requested.On (b)(6) 2021, after unknown latency, the patient had covid 19 (covid-19, required hospitalization) and for this reason she was also in the icu (intensive care unit) in (b)(6)2021 (considered date: (b)(6) 2021).In 2022 (exact date not provided), after unknown latency, the patient was diagnosed with diabetes (diabetes mellitus, medically significant), cardiac arrhythmia (arrhythmia, medically significant), high blood pressure (hypertension) and depression.The patient was recently prescribed toujeo insulin, which the patient had not started yet with the application.Reporter did not provide further information.Action taken: unknown for all the events.The patient was treated with insulin glargine (toujeo) for diabetes mellitus, not reported for all the events.At time of reporting, the outcome was unknown for all the events.Reporter causality: unassessable for all the events.Company causality: not reportable for all the events.

Manufacturer Narrative

Sanofi company comment for follow up dated 17-jan-2023: follow up information received does not change prior case assessment.This case involves a 75 years old female patient who had covid 19, diabetes, cardiac arrhythmia, high blood pressure and depression while being treated with medical device hylan g-f 20, sodium hyaluronate (synvisc).Based on the available information, causal relationship between the events and suspect product could not be established.Patient¿s advanced age could be considered as a major factor in occurrence of events- diabetes, cardiac arrhythmia, high blood pressure and depression.However, further information regarding onset latency, patient¿s medical history, past medications, concomitant medications, concurrent clinical presentation, and other risk factors would aid in better case assessment.

Event Description

Covid 19 [covid-19] diabetes [diabetes] cardiac arrhythmia [cardiac arrhythmia] high blood pressure, arterial hypertension [arterial hypertension] depression [depression].Case narrative: initial information was received on 03-jan-2023 regarding a solicited valid serious case from a consumer/non-hcp, in the scope of patient support program "psp_synvisc_prosane".Patient id: (b)(6); country: peru.Study title: patient support program involving synvisc.This case involves a 75 years old female patient who had covid 19, diabetes, cardiac arrhythmia, high blood pressure and depression while being treated with medical device hylan g-f 20, sodium hyaluronate (synvisc).The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On an unknown date between 2020 and 2021, the patient received hylan g-f 20, sodium hyaluronate injection via intra-articular route (with an unknown dose, frequency) for knee osteoarthritis.There will be no information available on batch number of this case (batch number: not reported (reporter does not have it available), expiration date: not reported (reporter does not have it available).On (b)(6) 2021, after unknown latency, the patient had covid 19 (covid-19, required hospitalization) and for this reason she was also in the icu (intensive care unit) in (b)(6) 2021.In 2022 (exact date not provided), after unknown latency, the patient was diagnosed with diabetes (diabetes mellitus, medically significant), cardiac arrhythmia (arrhythmia, medically significant), high blood pressure, arterial hypertension (hypertension) and depression.The patient was recently prescribed toujeo insulin, which the patient had not started yet with the application.Reporter did not provide further information.Upon follow-up, the reporter being a relative of the patient, indicated that she does not know the exact date on which the patient was diagnosed with diabetes, depression, arrhythmia, and arterial hypertension, she only knows that it was in 2022.The patient is feeling better.The reporter does not wish to provide further information.Action taken: unknown for the event covid-19 and not applicable for other events.The patient was recently prescribed toujeo insulin and was using the same to treat diabetes.The patient was feeling better, not reported for all the other events.At time of reporting, the outcome was recovering/ resolving for all the events.Reporter causality: not related for all the events.Company causality: not reportable for all the events.A product technical complaint (ptc) was initiated, and the results were pending for the same.Additional information was received on 17-jan-2023 from the patient's relative.Outcome of the events hypertension, diabetes mellitus, depression and arrhythmia was updated.Action taken updated in product screen.Text amended accordingly.

Event Description

Covid 19 [covid-19].Diabetes [diabetes].Cardiac arrhythmia [cardiac arrhythmia].High blood pressure, arterial hypertension [arterial hypertension].Depression [depression].Case narrative: initial information was received on 03-jan-2023 regarding a solicited valid serious case from a consumer/non-hcp, in the scope of patient support program "psp_synvisc_prosane".Patient id: (b)(6); country: (b)(6).Study title: patient support program involving synvisc.This case involves 75 years old female patient who had covid 19, diabetes, cardiac arrhythmia, high blood pressure and depression while being treated with medical device hylan g-f 20, sodium hyaluronate (synvisc).The patient's past medical history, medical treatment(s), and family history were not provided.On an unknown date between 2020 and 2021, the patient received hylan g-f 20, sodium hyaluronate injection, liquid (solution) (strength: 16 mg/2 ml) via intra-articular route (with an unknown dose, frequency, batch number and expiry date) for knee osteoarthritis.There will be no information available on batch number and expiry date of this case.On (b)(6)2021, after unknown latency, the patient had covid 19 (covid-19, required hospitalization) and for this reason she was also in the icu (intensive care unit) on (b)(6) 2021.In 2022 (exact date not provided), after unknown latency, the patient was diagnosed with diabetes (diabetes mellitus, medically significant), cardiac arrhythmia (arrhythmia, medically significant), high blood pressure, arterial hypertension (hypertension) and depression.The patient was recently prescribed toujeo insulin, which the patient had not started yet with the application.Upon follow-up, the reporter being a relative of the patient, indicated that she does not know the exact date on which the patient was diagnosed with diabetes, depression, arrhythmia, and arterial hypertension, she only knows that it was in 2022.The patient was feeling better.Action taken: unknown for the event covid-19 and not applicable for other events.Corrective treatment: the patient was recently prescribed toujeo insulin to treat diabetes mellitus and not reported for rest of the events.At time of reporting, the outcome was recovering for all events.Reporter causality: not related for all events.Company causality: not reportable for all events.A product technical complaint (ptc) was initiated on 17-jul-2023 for synvisc (batch number: unknown) with global ptc number: (b)(4).The sample status of the ptc was not available.Ptc stated: complaint: adverse event 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.Investigation: the product lot number was not provided.A batch record review is not possible.Based on the lack of information, no assessment is possible.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.Sanofi will continue to monitor adverse events and perform trend analysis on a periodic basis to determine if a capa (corrective and preventive action) is required.The final investigation was completed on 28-jul-2023 with summarized conclusion as no assessment possible.The reporter does not wish to provide further information.Additional information was received on 17-jan-2023 from the patient's relative.Outcome of the events hypertension, diabetes mellitus, depression and arrhythmia was updated.Action taken updated in product screen.Text amended accordingly.Additional information was received on 17-jul-2023 from quality department (other healthcare professional).Suspect product formulation, strength and global ptc number were added.Text amended accordingly.Additional information was received on 28-jul-2023 from quality department (other healthcare professional).Ptc results were added.Text amended accordingly.

Event Description

Covid 19 [covid-19] diabetes [diabetes] cardiac arrhythmia [cardiac arrhythmia] high blood pressure, arterial hypertension [arterial hypertension] depression [depression] case narrative: initial information was received on 03-jan-2023 regarding a solicited valid serious case from a consumer/non-hcp, in the scope of patient support program "psp_synvisc_prosane".Patient id: (b)(6); country: peru study title: patient support program involving synvisc.This case involves a 75 years old female patient who had covid 19, diabetes, cardiac arrhythmia, high blood pressure and depression while being treated with medical device hylan g-f 20, sodium hyaluronate (synvisc).The patient's past medical history, medical treatment(s), and family history were not provided.On an unknown date between 2020 and 2021, the patient received hylan g-f 20, sodium hyaluronate injection, liquid (solution) (strength: 16 mg/2 ml) via intra-articular route (with an unknown dose, frequency) for knee osteoarthritis.There will be no information available on batch number of this case (batch number: not reported (reporter does not have it available), expiration date: not reported (reporter does not have it available).On (b)(6) 2021, after unknown latency, the patient had covid 19 (covid-19, required hospitalization) and for this reason she was also in the icu (intensive care unit) in (b)(6) 2021.In 2022 (exact date not provided), after unknown latency, the patient was diagnosed with diabetes (diabetes mellitus, medically significant), cardiac arrhythmia (arrhythmia, medically significant), high blood pressure, arterial hypertension (hypertension) and depression.The patient was recently prescribed toujeo insulin, which the patient had not started yet with the application.Reporter did not provide further information.Upon follow-up, the reporter being a relative of the patient, indicated that she does not know the exact date on which the patient was diagnosed with diabetes, depression, arrhythmia, and arterial hypertension, she only knows that it was in 2022.The patient is feeling better.The reporter does not wish to provide further information.Action taken: unknown for the event covid-19 and not applicable for other events.The patient was recently prescribed toujeo insulin and was using the same to treat diabetes.The patient was feeling better, not reported for all the other events at time of reporting, the outcome was recovering/ resolving for all the events reporter causality: not related for all the events company causality: not reportable for all the events a product technical complaint (ptc) was initiated on 17-jul-2023 for synvisc (batch number: unknown) with global ptc number: 100344468.The sample status of the ptc was not available and the ptc was set in process.Additional information was received on 17-jan-2023 from the patient's relative.Outcome of the events hypertension, diabetes mellitus, depression and arrhythmia was updated.Action taken updated in product screen.Text amended accordingly.Additional information was received on 17-jul-2023 from quality department (other healthcare professional).Suspect product formulation, strength and global ptc number were added.Text amended accordingly.

Manufacturer Narrative

Sanofi company comment for follow up dated 17-jul-2023: follow up information received does not change prior case assessment.This case involves a 75 years old female patient who had covid 19, diabetes, cardiac arrhythmia, high blood pressure and depression while being treated with medical device hylan g-f 20, sodium hyaluronate (synvisc).Based on the available information, causal relationship between the events and suspect product could not be established.Patient¿s advanced age could be considered as a major factor in occurrence of events- diabetes, cardiac arrhythmia, high blood pressure and depression.However, further information regarding onset latency, patient¿s medical history, past medications, concomitant medications, concurrent clinical presentation, and other risk factors would aid in better case assessment.

• Brand Name: SYNVISC
• Type of Device: MOZ
• 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: 16119829
• MDR Text Key: 306880620
• Report Number: 2246315-2023-00003
• 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: Foreign,Study,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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): Hospitalization; Other; Required Intervention
• Patient Sex: Female