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

Lot Number 9RSP007C

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

Patient Problem Myocardial Infarction (1969)

Event Type  Death  

Manufacturer Narrative

Sanofi company comment dated (b)(6) 2023: this case involves a 93 years old male patient who deceased/passed away from a heart attack , after the use of medical device hylan g-f 20, sodium hyaluronate (synvisc).Based on the available information, causal relationship between the events and suspect product can be denied.However, further information regarding patient¿s medical history, past medications, concomitant medications, underlying conditions, and other risk factors would aid in better case assessment.

Event Description

Deceased/passed away from a heart attack [heart attack] case narrative: initial information received on (b)(6) 2023 regarding a solicited valid serious case received from a patient's wife (non-healthcare professional), in the scope of post-marketing sponsored study "spon_i_synvisc".The case is cross referred to the case (b)(4) (multiple device suspect used for the same patient) patient id: unknown; country: canada.Study title: patient support program involving synvisc.This case involves a 93 years old male patient who deceased/passed away from a heart attack while being treated with hylan g-f 20, sodium hyaluronate [synvisc].The patient's past medical history, medical treatment(s), concomitant disease or risk factor, vaccination(s) and family history were not provided.On (b)(6) 2020, the patient started taking synvisc (hylan g-f 20, sodium hyaluronate) injection in the left knee at a dose of 2ml 3x (thrice) (lot - 9rsp007c) (with unknown strength, route, frequency, indication and expiry date).Patient's wife mentioned that patient passed away from a heart attack (myocardial infarction) (onset: (b)(6) 2023 and latency: 2 years 8 months) (seriousness criteria: medically significant, hospitalization and fatal).It was unknown if autopsy was performed and the cause of death was reported as heart attack.It was unknown if there were lab data/results available.Action taken: not applicable.It was not reported if the patient received a corrective treatment for the event (passed away from a heart attack).Outcome: fatal reporter causality: not reported company causality: not reportable.

Event Description

Deceased/passed away from a heart attack.Case narrative: initial information received on 18-aug-2023 regarding a solicited valid serious case received from a patient's wife (non-healthcare professional), in the scope of post-marketing sponsored study "spon_i_synvisc".The case is cross referred to the case (b)(4) (multiple device suspect used for the same patient).Patient id: unknown; country: canada.Study title: patient support program involving synvisc.This case involves a (b)(6) male patient who deceased/passed away from a heart attack while being treated with hylan g-f 20, sodium hyaluronate [synvisc].The patient's past medical history, medical treatment(s), concomitant disease or risk factor, vaccination(s) and family history were not provided.On (b)(6) 2020, the patient started taking synvisc (hylan g-f 20, sodium hyaluronate) injection of strength 16 mg/2 ml in the left knee at a dose of 2ml 3x (thrice) (lot - 9rsp007c) (with unknown route, indication and expiry date).Patient's wife mentioned that patient passed away from a heart attack in the hospital.(myocardial infarction) (onset: (b)(6) 2022 and latency: 2 years 7 months 29 days).(seriousness criteria: medically significant and fatal).It was unknown if autopsy was performed and the cause of death was reported as heart attack.It was unknown if there were lab data/results available.Action taken: not applicable.It was not reported if the patient received a corrective treatment for the event (passed away from a heart attack).Outcome: fatal.Reporter causality: not reported.Company causality: not reportable.A product technical complaint (ptc) was initiated on 18-aug-2023 for synvisc (lot/batch number: 9rsp007c) with global ptc number: (b)(4).The sample status of the ptc was not available, and ptc was set in process additional information was received on 18-aug-2023 by quality department: ptc number added.Strength added; text amended.

Event Description

Deceased/passed away from a heart attack [heart attack].Case narrative: initial information was received on 18-aug-2023 regarding a solicited valid serious case from patient's wife (non-healthcare professional), in the scope of post-marketing sponsored study "spon_i_synvisc".The case is cross referred to the (b)(4) (multiple device suspect used for the same patient).Patient id: unknown; country: canada.Study title: patient support program involving synvisc.This case involves (b)(6) patient who was deceased/passed away from a heart attack while being treated with hylan g-f 20, sodium hyaluronate [synvisc].The patient's past medical history, medical treatment(s), concomitant disease or risk factor, and family history were not provided.On (b)(6) 2020, the patient started taking synvisc (hylan g-f 20, sodium hyaluronate) injection of strength 16 mg/2 ml in the left knee at a dose of 2ml 3x (thrice) (lot - 9rsp007c, expiry date: 30-apr-2022) (with unknown route, indication).Patient's wife mentioned that patient passed away from a heart attack in the hospital (myocardial infarction) (onset: (b)(6) 2022 and latency: 2 years 7 months 29 days) (seriousness criteria: medically significant and fatal).It was unknown if autopsy was performed and the cause of death was reported as heart attack.It was unknown if there were lab data/results available.Action taken: not applicable.Corrective treatment: not reported for myocardial infarction.Outcome: fatal.Reporter causality: not reported.Company causality: not reportable.A product technical complaint (ptc) was initiated on 18-aug-2023 for synvisc (lot/batch number: 9rsp007c, expiry date: 30-apr-2022) with global ptc number: (b)(4).The sample status of the ptc was not available.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.The production and quality control documentation for lot #9rsp007c expiration date (2022-04) was manufactured on 07may2019 packaged 1500 kits were reviewed.The investigation showed that the product met specifications.No associated non-conformances were noted.Based on the lot # batch record review & lot # frequency analysis for lot #9rsp007c no capa (corrective and preventive action) is required.As of 29aug23 there are 7 complaints on file for lot# 9rsp007 and all related sublots.1 complaint is on file for lot# 9rsp007: (1) syringe broken prior.6 complaints are on file for lot# 9rsp007c: (1) syringe broken while in use and (5) adverse event reports.Sanofi will continue to monitor complaints and trending to determine if a capa is required.The final investigation was completed on 31-aug-2023 with summarized conclusion as no assessment possible.Additional information was received on 18-aug-2023 by quality department: ptc number added.Strength added; text amended additional information was received on 31-aug-2023 by quality department: ptc results was added along with expiry date.Text amended accordingly.

Event Description

Deceased/passed away from a heart attack [heart attack] case narrative: initial information was received on 18-aug-2023 regarding a solicited valid serious case from patient's wife (non-healthcare professional), in the scope of post-marketing sponsored study "spon_i_synvisc".Patient id: unknown; country: canada study title: patient support program involving synvisc.The case is cross referred to the case 2023sa255637 (multiple device suspect used for the same patient) this case involves 93 years old male patient who was deceased/passed away from a heart attack while being treated with hylan g-f 20, sodium hyaluronate [synvisc].The patient's past medical history, medical treatment(s), concomitant disease or risk factor, and family history were not provided.On 25-feb-2020, the patient started taking synvisc (hylan g-f 20, sodium hyaluronate) injection in the left knee at a dose of 2ml thrice (strength: 16mg/2ml, lot number: 9rsp007c, expiry date: 30-apr-2022, with unknown route) for osteoarthritis grade iv.The patient was having synvisc injection from many years and was taking it every six months.The last synvisc injection administered to the patient were on 16-aug-2022 in the left knee (lateral injection under ultrasound) and on 30-aug-2022 in the right knee (lateral injection).Patient's wife mentioned that patient passed away from a heart attack in the hospital (myocardial infarction) (onset: 24-oct-2022 and latency: 2 years 7 months 29 days) (seriousness criteria: medically significant and fatal).It was unknown if autopsy was performed, and the cause of death was reported as heart attack.As per healthcare professional response, there was no link between patient last synvisc injection and the patient's death.It was unknown if there were lab data/results available.Action taken: not applicable.Corrective treatment: not reported for myocardial infarction.Outcome: fatal reporter causality: not related company causality: not reportable seriousness criteria: medically significant and death a product technical complaint (ptc) was initiated on 18-aug-2023 for synvisc (lot/batch number: 9rsp007c, expiry date: 30-apr-2022) with global ptc number: 100353301.The sample status of the ptc was not available.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.The production and quality control documentation for lot #9rsp007c expiration date (2022-04) was manufactured on 07may2019 packaged 1500 kits were reviewed.The investigation showed that the product met specifications.No associated non-conformances were noted.Based on the lot # batch record review & lot # frequency analysis for lot #9rsp007c no capa (corrective and preventive action) is required.As of 29aug23 there are 7 complaints on file for lot# 9rsp007 and all related sublots.1 complaint is on file for lot# 9rsp007: (1) syringe broken prior.6 complaints are on file for lot# 9rsp007c: (1) syringe broken while in use and (5) adverse event reports.Sanofi will continue to monitor complaints and trending to determine if a capa is required.The final investigation was completed on 31-aug-2023 with summarized conclusion as no assessment possible.Additional information was received on 18-aug-2023 by quality department: ptc number added.Strength added; text amended additional information was received on 31-aug-2023 by quality department: ptc results was added along with expiry date.Text amended accordingly.Additional information was received on 15-sep-2023 from other healthcare professional: indication was added.Reporter causality was updated.Clinical course was updated.Text amended accordingly.

• 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: 17609848
• MDR Text Key: 321801998
• Report Number: 2246315-2023-00093
• 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,Consumer,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 04/30/2022
• Device Lot Number: 9RSP007C
• 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): Other; Death
• Patient Sex: Male