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 Myocardial Infarction (1969); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/01/2022

Event Type  Injury  

Manufacturer Narrative

Sanofi company comment dated (b)(6) 2023.This case involves an elderly female patient who had a heart attack with the use of a medical device hylan g-f 20, sodium hyaluronate [synvisc].Based on the information received, causal role of the company suspect product cannot be excluded.The case will be re-evaluated post-further update regarding concomitant medications.Furthermore, the role of past medical history cannot be ignored.

Event Description

Heart attack [heart attack].Another four knee surgeries due to an allergy to the prothesis [knee surgery nos].Another four knee surgeries due to an allergy to the prothesis [device allergy].Patient used synvisc for psoriatic arthritis and collie arthritis with no reported adverse event [product use in unapproved indication].Case narrative: initial information was received from canada on 11-sep-2023 regarding an unsolicited valid serious case received from a patient.This case involves an elderly female patient who had a heart attack, another four knee surgeries due to an allergy to the prothesis, and a patient who used synvisc for psoriatic arthritis and collie arthritis with no reported adverse event with the use of a medical device hylan g-f 20, sodium hyaluronate [synvisc].The patient's past medical history included knee arthroplasty in 2000 and a knee operation in 2010 with first knee surgery on the left knee.The patient's past medical treatment(s), vaccination(s), and family history were not provided.At the time of the event, the patient had ongoing osteoarthritis, collie arthritis and psoriatic arthritis.In 2013, the patient received synvisc (hylan g-f 20, sodium hyaluronate) injection at an unknown dosage, frequency, strength, route, expiry date, and batch number for osteoarthritis,collie arthritis and psoriatic arthritis (product use in unapproved indication) (latency: same day).Information on the batch number was requested.Patient mentioned that years ago she had synvisc injected in her right knee and it was very effective, lasted almost ten years, then patient had to have a knee replacement back in 2000 she had a few injections of synvisc or something like that during the last four years she had quite a few, (during covid) another four knee surgeries due to an allergy to the prothesis(knee operation)( device allergy)(onset date: 2019;latency: 6 years).She also had a heart attack(myocardial infarction)(onset date:2022;latency: 9 years) a year ago and was on blood thinners which prevents her from getting any surgeries, she mentioned she was a very active person, in 2010 it was her first knee surgery on the left knee, she also just had heart surgery and had three great big stints put in, therefore to avoid surgery, patient did not provide her date of birth, however did say she was years old.Corrective treatment: heart surgery and had three great big stints put for the event of myocardial infarction.Outcome: not recovered / not resolved for the event of myocardial infarction, unknown for remaining events.Seriousness criteria: medically significant and intervention required for myocardial infarction and knee operation.

Event Description

Heart attack.Another four knee surgeries due to an allergy to the prothesis [knee surgery nos].Patient used synvisc for psoriatic arthritis and collie arthritis with no reported adverse event [product use in unapproved indication].Case narrative: initial information was received from canada on 11-sep-2023 regarding an unsolicited valid serious case received from a patient.This case involves 87 years old female patient who had a heart attack, another four knee surgeries due to an allergy to the prothesis, with the use of a medical device hylan g-f 20, sodium hyaluronate [synvisc] used for psoriatic arthritis and collie arthritis with no reported adverse event.The patient's past medical history included knee replacement in 2000 and a knee surgery in 2010 with first knee surgery on the left knee.At the time of the event, the patient had ongoing osteoarthritis, collie arthritis and psoriatic arthritis.The patient's past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.In 2013, the patient received synvisc (hylan g-f 20, sodium hyaluronate) injection, strength: 16mg/2ml, (at an unknown dosage, frequency, route, expiry date, and batch number) for osteoarthritis, collie arthritis and psoriatic arthritis (product use in unapproved indication) (latency: same day).Information on the batch number was requested.Patient mentioned that years ago she had synvisc injected in her right knee and it was very effective, lasted almost ten years.She had a few injections of synvisc or something like that during the last four years she had quite a few, (during covid) another four knee surgeries due to an allergy to the prothesis (knee operation) (onset date: 2019; latency: 6 years).She also had a heart attack (myocardial infarction) (onset date:2022; latency: 9 years) a year ago and was on blood thinners which prevents her from getting any surgeries, she mentioned she was a very active person, she also just had heart surgery and had three great big stints put in, therefore to avoid surgery.Action taken: not applicable for all events.Corrective treatment: heart surgery and had three great big stints put for the event of myocardial infarction.Outcome: not recovered / not resolved for the event of myocardial infarction, unknown for remaining events.Seriousness criteria: medically significant and intervention required for myocardial infarction and knee operation.A product technical complaint (ptc) was initiated on 11-sep-2023 for synvisc (batch number: unknown) with global ptc number (b)(4).The sample status was not available.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 - (dp 12sep23).Product updated from synvisc one to synvisc.(em 26sep2023).Investigation (em 14sep2023)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 as per rid-qu-sop-0040594.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 26-sep-2023 with summarized conclusion as no assessment possible.Additional information was received on 25-sep-2023 from healthcare professional (quality department).Clinical course was updated.Text amended accordingly.Additional information was received on 26-sep-2023 from healthcare professional (quality department).Ptc results were added.Text amended accordingly.

Event Description

Heart attack [heart attack] another four knee surgeries due to an allergy to the prothesis [knee surgery nos] right sciatica [r sciatica] patient used synvisc for psoriatic arthritis and collie arthritis with no reported adverse event [product use in unapproved indication].Case narrative: initial information was received from canada on (b)(6) 2023 regarding an unsolicited valid serious case received from a patient.This case involves 87 years old female patient who had a heart attack, another four knee surgeries due to an allergy to the prothesis and right sciatica with the use of a medical device hylan g-f 20, sodium hyaluronate [synvisc] used for psoriatic arthritis and collie arthritis with no reported adverse event directly linked with product use in unapproved indication.The patient's past medical history included knee replacement in 2000 and a knee surgery in 2010 with first knee surgery on the left knee.Her past medical treatment included back surgery and vasectomy (in 1975).Her family history included that all her brothers had heart issues.At the time of the event, the patient had ongoing osteoarthritis, collie arthritis and psoriatic arthritis.Concomitant medications included amlodipine besilate (norvasc); atorvastatin calcium (lipitor); estrogens conjugated (premarin); levothyroxine sodium (synthroid); folic acid; clopidogrel; tramadol; methotrexate for arthritis; acetylsalicylic acid (asa); magnesium; atenolol; gliclazide (diazide) and allopurinol (alopurinol).In 2013, the patient received synvisc (hylan g-f 20, sodium hyaluronate) injection, strength: 16mg/2ml, (at an unknown dosage, frequency, route, expiry date, and batch number) for osteoarthritis, collie arthritis and psoriatic arthritis (product use in unapproved indication) (latency: same day).Information on the batch number was requested.Patient mentioned that years ago she had synvisc injected in her right knee and it was very effective, lasted almost ten years.She had a few injections of synvisc or something like that during the last four years she had quite a few, (during covid) another four knee surgeries due to an allergy to the prothesis (knee operation) (onset date: 2019; latency: 6 years).She also had a heart attack (myocardial infarction) (onset date:2022; latency: 9 years) a year ago and was on blood thinners which prevents her from getting any surgeries, she mentioned she was a very active person, she also just had heart surgery and had three great big stints put in, therefore to avoid surgery.On the unknown date of 2021, after the latency of 8 years of starting the treatment with hylan g-f 20, sodium hyaluronate, patient had right sciatica.Action taken: not applicable for all events.Corrective treatment: heart surgery and had three great big stints put for the event of myocardial infarction; not reported for right sciatica.Outcome: not recovered / not resolved for the event of myocardial infarction, unknown for remaining events.Seriousness criteria: medically significant and intervention required for myocardial infarction and knee operation.A product technical complaint (ptc) was initiated on (b)(6) 2023 for synvisc (batch number: unknown) with global ptc number (b)(4).The sample status was not available.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) (b)(6) 2023).Product updated from synvisc one to synvisc.((b)(6) 2023) investigation ((b)(6) 2023)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 as per (b)(4).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 (b)(6) 2023 with summarized conclusion as no assessment possible.This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in directive 2001/83/ec and module vi of the good pharmacovigilance practices.The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.Additional information was received on 25-sep-2023 from healthcare professional (quality department).Clinical course was updated.Text amended accordingly.Additional information was received on 26-sep-2023 from healthcare professional (quality department).Ptc results were added.Text amended accordingly.Additional information was received on (b)(6) 2023 from the patient.Additional event of right sciatica added.Concomitant medications added.Clinical course updated and text amended accordingly.Based on the information previously received the significant for device box has been amended.

• 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: 17762697
• MDR Text Key: 323583547
• Report Number: 2246315-2023-00096
• 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,Consumer,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/20/2023

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 Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/18/2023
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 09/29/2023; 11/20/2023
• 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
• Treatment: ALOPURINOL (ALLOPURINOL),UNKNOWN; ASA (ACETYLSALICYLIC ACID),UNKNOWN; ATENOLOL (ATENOLOL),UNKNOWN; CLOPIDOGREL (CLOPIDOGREL),UNKNOWN; DIAZIDE [GLICLAZIDE] (GLICLAZIDE),UNKNOWN; FOLIC ACID (FOLIC ACID),UNKNOWN; LIPITOR (ATORVASTATIN CALCIUM),UNKNOWN; MAGNESIUM (MAGNESIUM),UNKNOWN; METHOTREXATE (METHOTREXATE),INJECTION; NORVASC (AMLODIPINE BESILATE),UNKNOWN; PREMARIN (ESTROGENS CONJUGATED),UNKNOWN; SYNTHROID (LEVOTHYROXINE SODIUM),UNKNOWN; TRAMADOL (TRAMADOL),UNKNOWN
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 87 YR
• Patient Sex: Female