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 Stenosis (2263); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

Subglottic stenosis [subglottic stenosis] lt lat epicondylitis, rt medial epicondylitis [epicondylitis] case narrative: initial information received on 08-dec-2023 regarding a solicited valid serious case received from a physician, in the scope of post-marketing sponsored study "spon_i_synvisc".Patient id: unknown; country:(b)(6).Study title: patient support program involving synvisc.This case involves adult female patient who was diagnosed with subglottic stenosis and lt lat epicondylitis, rt medial epicondylitis while being treated with hylan g-f 20, sodium hyaluronate [synvisc].The patient's past medical history, medical treatment(s), and family history were not provided.Concomitant medications included triamcinolone acetonide (kenalog 40).On (b)(6) 2020, the patient started taking hylan g-f 20, sodium hyaluronate first injection in left knee at a dose of 6 ml via intra-articular route (with an unknown strength, batch number and expiry date) for knee osteoarthritis.Information on batch number was requested.On an unknown date (latency: unknown), the patient was diagnosed with subglottic stenosis (laryngeal stenosis) and lt (left) lat (lateral) epicondylitis, rt (right) medial epicondylitis (epicondylitis).Action taken was unknown for both the events.It was not reported if the patient received a corrective treatment for both the events.Outcome: recovering / resolving for laryngeal stenosis and unknown for epicondylitis.Reporter causality: not reported for both the events.Company causality: not reportable for both the events.Seriousness criteria: medically significant for laryngeal stenosis.

Event Description

Subglottic stenosis [subglottic stenosis].Lt lat epicondylitis, rt medial epicondylitis [epicondylitis].Case narrative: initial information received on 08-dec-2023 regarding a solicited valid serious case received from a physician, in the scope of post-marketing sponsored study "(b)(6)".Patient id: unknown; country: canada.Study title: patient support program involving synvisc.This case involves adult female patient who was diagnosed with subglottic stenosis and lt lat epicondylitis, rt medial epicondylitis while being treated with hylan g-f 20, sodium hyaluronate [synvisc].The patient's past medical history, medical treatment(s), and family history were not provided.Concomitant medications included triamcinolone acetonide (kenalog 40).On (b)(6) 2020, the patient started taking hylan g-f 20, sodium hyaluronate first injection in left knee of strength: 16mg/2ml, at a dose of 6 ml via intra-articular route (with an unknown frequency, expiry date) (synvisc injections in the left knee on (b)(6) 2023 (lot #crsp010a) on (b)(6) 2023 (lot #crsp015e3 and (b)(6) 2023 (lot #drsp012e3) for knee osteoarthritis.Information on missing batch number was requested.On an unknown date (latency: unknown), the patient was diagnosed with subglottic stenosis (laryngeal stenosis) and lt (left) lat (lateral) epicondylitis, rt (right) medial epicondylitis (epicondylitis).Action taken was unknown for both the events.It was not reported if the patient received a corrective treatment for both the events.Outcome: recovering / resolving for laryngeal stenosis and unknown for epicondylitis.Reporter causality: not reported for both the events.Company causality: not reportable for both the events.Seriousness criteria: medically significant for laryngeal stenosis.A product technical complaint (ptc) was initiated on 08-dec-2023 for synvisc (hylan g-f 20, sodium hyaluronate) (batch number: unknown) with global ptc number: (b)(4).The sample was not available and ptc was set in process.Additional information was received on 08-dec-2023 from quality department: ptc details with global ptc number and suspect strength, batch numbers added.Text was amended accordingly.

Event Description

Subglottic stenosis [subglottic stenosis].Left lateral epicondylitis/ left tennis elbow, right medical epicondylitis [epicondylitis].Case narrative: initial information was received on 08-dec-2023 regarding a solicited valid serious case from a physician, in the scope of post-marketing sponsored study "spon_i_synvisc".Patient id: unknown; country: canada.Study title: patient support program involving synvisc.This case involves an adult female patient who was diagnosed with subglottic stenosis and left lateral epicondylitis/ left tennis elbow, right medical epicondylitis while being treated with hylan g-f 20, sodium hyaluronate [synvisc].The patient's past medical history, medical treatment(s), and family history were not provided.The patient had ongoing left knee osteoarthritis.Concomitant medications included triamcinolone acetonide (kenalog 40).On (b)(6) 2020, the patient started taking hylan g-f 20, sodium hyaluronate first injection in left knee of strength: 16mg/2ml, at a dose of 6 ml via intra-articular route (with an unknown frequency, batch number, expiry date) for knee osteoarthritis.Information on missing batch number was requested.Since an unknown date (latency: unknown), the patient was diagnosed with subglottic stenosis (laryngeal stenosis) for which the patient received treatment to open trachea and had left lateral epicondylitis/ left tennis elbow, right medical epicondylitis.The patient also received synvisc injections in the left knee on (b)(6) 2023 (lot number: crsp010a) mild pain relief (in conjunction with tropocells prp - 11ml), on (b)(6) 2023 (lot #crsp015b (in conjunction with kenalog 40mg) and (b)(6) 2023 (lot number: drsp012b) (in conjunction with kenalog 40mg).Within the treatment plan dated (b)(6) 2023, following was indicated: subglottic stenosis improved, diagnosis; left lateral epicondylitis right medical epicondylitis.Action taken was unknown for both the events.Corrective treatment: received unspecified treatment to open trachea for subglottic stenosis.It was not reported if the patient received a corrective treatment for left lateral epicondylitis/ left tennis elbow, right medical epicondylitis.Outcome: recovering for laryngeal stenosis and unknown for epicondylitis.Reporter causality: not reported for both the events.Company causality: not reportable for both the events.Seriousness criteria: medically significant for laryngeal stenosis.A product technical complaint (ptc) was initiated on 08-dec-2023 for synvisc (hylan g-f 20, sodium hyaluronate) (batch number: unknown) with global ptc number: (b)(4).The sample 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.(em 13dec2023) investigation (em 13dec2023) 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 is required.The final investigation was completed on 14-dec-2023 and the summarized conclusion was no assessment possible.Additional information was received on 08-dec-2023 from quality department: ptc details with global ptc number and suspect strength, batch numbers added.Text was amended accordingly.Additional information was received on 14-dec-2023 from quality department: ptc results were added.Text amended accordingly.

Event Description

Subglottic stenosis [subglottic stenosis] case narrative: initial information was received on 08-dec-2023 regarding a solicited valid serious case from a physician, in the scope of post-marketing sponsored study "spon_i_synvisc".Patient id: unknown; country: canada study title: patient support program involving synvisc.This case involves an adult female patient who was diagnosed with subglottic stenosis while being treated with hylan g-f 20, sodium hyaluronate [synvisc].The patient's past medical history, medical treatment(s), and family history were not provided.The patient had ongoing left knee osteoarthritis, rheumatoid arthritis and bilateral medial and lateral epicondylitis.Concomitant medications included triamcinolone acetonide (kenalog 40).On (b)(6) 2020, the patient took hylan g-f 20, sodium hyaluronate first injection in left knee of strength: 16mg/2ml, at a dose of 6 ml via intra-articular route (with an unknown frequency, batch number, expiry date) for left knee osteoarthritis.Information on missing batch number was requested.Since an unknown date (latency: unknown), the patient was diagnosed with subglottic stenosis (laryngeal stenosis) for which the patient received treatment to open trachea.The patient also received synvisc injections in the left knee on (b)(6) 2023 (lot number: crsp010a) mild pain relief (in conjunction with tropocells prp(platelet-rich plasma) - 11ml), on (b)(6) 2023 (lot #crsp015b (in conjunction with kenalog 40mg) and (b)(6) 2023 (lot number: drsp012b) (in conjunction with kenalog 40mg).Within the treatment plan dated (b)(6) 2023, following was indicated: subglottic stenosis improved, diagnosis; left lateral epicondylitis right medical epicondylitis.Upon follow-up, physician reported that, the patient has been treated since (b)(6) 2019.She has underlying rheumatoid arthritis and the primary conditions for which she has been treated included - bilateral medial and lateral epicondylitis and left knee osteoarthritis.She has been treated with a combination of steroid injections, viscosupplementation including multivisk and synvisc, as well as prp injections every 3-6 months on an as needed basis.She has never experienced an adverse event following one of her procedures.On (b)(6) 2023 physician noted that patient was under investigation for subglottic stenosis that to his/her knowledge was related to an underlying genetic predisposition or her rheumatoid arthritis.This did not develop as a result of patient's conditions or treatments she received at arthrobiologix including synvisc.No further details provided.Action taken was unknown.Corrective treatment: received unspecified treatment to open trachea for subglottic stenosis.Outcome: recovering for laryngeal stenosis.Reporter causality: not related company causality: not reportable seriousness criteria: medically significant for laryngeal stenosis.A product technical complaint (ptc) was initiated on (b)(6) 2023 for synvisc (hylan g-f 20, sodium hyaluronate) (batch number: unknown) with global ptc number: 100384283.The sample 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.(em (b)(6) 2023) investigation (em (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.Sanofi will continue to monitor adverse events and perform trend analysis on a periodic basis to determine if a capa is required.The final investigation was completed on 14-dec-2023 and the summarized conclusion was no assessment possible.Additional information was received on 08-dec-2023 from quality department: ptc details with global ptc number and suspect strength, batch numbers added.Text was amended accordingly.Additional information was received on 14-dec-2023 from quality department: ptc results were added.Text amended accordingly.Additional information was received on 16-feb-2024 from physician: concurrent condition of rheumatoid arthritis and bilateral medial and lateral epicondylitis were added.Reporter causality for event laryngeal stenosis was updated.Clinical course was updated and text was amended.

• 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: 18361792
• MDR Text Key: 330931765
• Report Number: 2246315-2023-00115
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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: KENALOG 40 (TRIAMCINOLONE ACETONIDE), UNKNOWN; KENALOG 40 (TRIAMCINOLONE ACETONIDE), UNKNOWN; KENALOG 40 (TRIAMCINOLONE ACETONIDE), UNKNOWN; KENALOG 40 (TRIAMCINOLONE ACETONIDE), UNKNOWN
• Patient Outcome(s): Required Intervention; Other
• Patient Sex: Female