MAUDE Adverse Event Report: FIDIA FARMACEUTICI S.P.A.; HYALURONATE SODIUM

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Edema (1820); Swelling (2091); Thrombosis (2100); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).On 28 november 2011, the fda granted the permission for the manufacturer fidia (b)(4).To submit a single mdr for adverse events that involve medical devices manufactured by fidia (b)(4).And imported into the usa by (b)(4).As a consequence, fidia (b)(4).(the manufacturer) is submitting this report even on behalf of (b)(4) (the importer).The present mdr report satisfies the reporting obligations for both companies.The literature case comes from the literature monitoring screening performed by the company.The patient after the injection of a product containing hyaluronate sodium as active substance experienced: deep vein thrombosis, peripheral swelling, sensation of heat, tenderness and pretibial edema.The case has been deemed as serious by the reporter due to hospitalization.The case has been deemed as serious/unexpected.The causality relationship has been evaluated as probable by the company.No new signal alert has been detected.The paper reference is: altinbas ö., çomakli h.Deep vein thrombosis after sodium hyaluronate injection to knee joint: a case report.J.Clin.Anal.Med.2018 9:5 (466-468).

Event Description

This case was detected in the medical literature from altinbas ö., çomakli h.Deep vein thrombosis after sodium hyaluronate injection to knee joint: a case report.J.Clin.Anal.Med.2018 9:5 (466-468).This spontaneous case was reported in the medical literature by a physician from (b)(6).A (b)(6) -year-old man was admitted to our clinic with complaints of lower right extremity pain, swelling, and difficulty while walking.These complaints had started 15 days previously.The patient had a history of sodium hyaluronate injection (20 mg/2 ml) to the right knee joint due to osteoarthritic joint pain one month before.Before the injection, right lower extremity venous doppler usg was performed for deep vein thrombosis but no thrombosis was detected.His symptoms did not diminish despite the nonsteroidal anti-inflammatory treatment.He reported hypertension and chronic obstructive pulmonary disease as additional diseases.After informed consent, the patient was included in this study.Physical examination of the patient's right leg revealed swelling of the whole extremity, increased heat, tenderness, and pretibial mild edema.Peripheral pulses were palpable and there were no signs of ischemia.His thigh and calf were painful during palpation and homan's sign was positive.Laboratory findings included complete blood count, c-reactive protein, and biochemistry results related to kidney and liver functions and these results were normal.But d-dimer was 3.9 mg/l, higher than a normal value.The thrombophilia panel results, including factor v leiden, fii prothrombin, mthfr c 677t, and mthfr a 1298 c, were normal.In addition, anti-cardiolipin and anti-phospho-lipid antibodies were negative; protein c, protein s, and antithrombin were normal.Right lower extremity venous doppler usg indicated acute-subacute thrombus material in the common, superficial, and deep femoral veins and in the popliteal vein.There was no flow or response to the compression.Low molecular weight heparin (lmwh) (enoxaparin sodium) 8000 anti xa/0.8 ml twice a day proper to his weight, upper knee compression socks, and elevation of the extremity were started as the initial therapy.Warfarin sodium, 5 mg a day, was added to the therapy in the third day and lmwh was stopped when his international normalised ratio (inr) was above 2.His symptoms diminished and he was discharged from the hospital one week after admission with the suggestion of monthly inr controls.The third month lower right extremity venous doppler usg revealed recanalized flow in the venous structures mentioned above but there was still thrombus material on the vein walls compatible with the chronic period.His inr value was proper for his treatment (between 2-3) so warfarin sodium treatment was continued for another three months.Sixth month venous doppler usg revealed complete patency in the common, superficial, and deep femoral veins and in the popliteal vein and there were no thrombus materials.But irregularity on venous wall structures was reported.Warfarin sodium treatment was stopped and treatment continued with 100 mg per day of acetylsalicylic acid.After six months of this therapy there was no repetition of symptoms or thrombus, and treatment was stopped at the end of one year.

• Type of Device: HYALURONATE SODIUM
• Manufacturer (Section D): FIDIA FARMACEUTICI S.P.A.; via ponte della fabbrica, 3/a; abano terme, padua 35031 ; IT 35031
• Manufacturer (Section G): FIDIA FARMACEUTICI S.P.A.; via ponte della fabbrica, 3/a; abano terme, padua 35031 ; IT 35031
• Manufacturer Contact: giuseppe di sante ; via ponte della fabbrica, 3/a; abano terme, padua 35031 ; IT 35031
• MDR Report Key: 7543860
• MDR Text Key: 109355512
• Report Number: 9610200-2018-00006
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: TU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/25/2018

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 Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/11/2018
• Initial Date Manufacturer Received: 05/07/2018
• Initial Date FDA Received: 05/25/2018
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 67 YR