MAUDE Adverse Event Report: GENZYME CORPORATION(RIDGEFIELD) SYNVISC ONE; INTRA-ARTICULAR INJECTION

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

Patient Problems Thrombosis (2100); Therapeutic Response, Decreased (2271)

Event Date 12/29/2017

Event Type  Injury  

Event Description

Knee did not feel right/ blood clot in that leg/ partially occlusive blood clot in calf vein [clot blood].If applying warm compresses could have made synvisc less effective [therapeutic response decreased].Case narrative: this unsolicited case from united states was received on 11-may-2018 from consumer (patient).This case concerns a (b)(6) female patient who received treatment with synvisc one injection and her knee did not feel right/ blood clot in that leg/ partially occlusive blood clot in calf vein (latency: 7 days) and wondered if applying warm compresses could have made synvisc less effective (therapeutic response decreased) patient had a right knee surgery last autumn to clean out torn cartilage in right knee.Patient also has a shoulder issue.No relevant past drugs and concomitant medications were reported.On (b)(6) 2017, the patient received treatment with intra-articular synvisc one injection, via intra-articular route once, at the dose of 6 ml (indication, lot number and expiration date: not reported).On (b)(6) 2017, 7 days after receiving the injection, the patient's knee did not feel right and she was diagnosed with blood clot in that leg.Ultrasound revealed partially occlusive blood clot in calf vein.She was advised using compression stocking; took baby aspirin and applied warm compresses to back of knee for clot.Patient wondered if applying warm compresses could have made synvisc less effective, but was advised that its gel-like mixture stays in joint space.Patient reported that her knee was feeling weird before synvisc injection.She also reported having bilateral synvisc-one injections previously with better results and more relief.Corrective treatment: compression stocking and baby aspirin for knee did not feel right/ blood clot in that leg/ partially occlusive blood clot in calf vein.Outcome: unknown for knee did not feel right/ blood clot in that leg/ partially occlusive blood clot in calf vein.A pharmaceutical technical complaint (ptc) was initiated on 04-jun-2018 for synvisc one batch number unknown with global ptc number (b)(4).The product lot number was not provided; therefore, a batch record review was not possible.Based on the lack of information provided, no capa was required.It was the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result was identified and mitigated through the ncr process.Sanofi global pharmacovigilance and epidemiology continuously monitored adverse event reports with or without lot numbers, and assessed possible associations with their corresponding product lot, as part of routine safety surveillance effort to detect safety signals.This review had not indicated any safety issue.Sanofi would continue to monitor adverse events to determine if a capa was required.Seriousness criterion: medically significant for knee did not feel right/blood clot in that leg/ partially occlusive blood clot in calf vein additional information was received on 04-jun-2018.Global ptc number and ptc results were added.Text was amended accordingly.Local comments: report scheduled with delay after case completion due to (b)(4) roll out report scheduling issue on archived cases.

• Brand Name: SYNVISC ONE
• Type of Device: INTRA-ARTICULAR INJECTION
• Manufacturer (Section D): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield 07657
• Manufacturer (Section G): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield 07657
• Manufacturer Contact: darlene kadel ; 55 corporate drive, ms 55b-220; a; bridgewater 08807
• MDR Report Key: 8394051
• MDR Text Key: 137946763
• Report Number: 2246315-2018-00870
• 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: consumer
• Type of Report: Initial
• Report Date: 03/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No
• 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; Required Intervention