MAUDE Adverse Event Report: BIO-TECHNOLOGY GENERAL (ISRAEL) LTD. EUFLEXXA; 1% SODIUM HYALURONATE

Catalog Number 6301182010

Device Problem Insufficient Information (3190)

Patient Problems Cyst(s) (1800); Thrombosis (2100)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Deep venous thrombosis (deep vein thrombosis).Right popliteal cyst (synovial cyst) the (b)(6) 2018 a serious spontaneous case reported in a medical journal by a health care professional in united states.This report concerns a (b)(6) male who experienced deep venous thrombosis and right popliteal cyst during treatment with unknown euflexxa (sodium hyaluronate) solution for injection, unknown concentration and dose, for arthritis from an unknown start date to an unknown stop date.The patient presented with right foot burning pain and weakness.Symptoms started 3 months prior to presentation after sodium hyaluronate right knee injection for treatment of arthritis.Two weeks after the injection, he was diagnosed with deep venous thrombosis and was anticoagulated for 3 months; however, symptoms did not resolve.He was receiving lumbar epidural injections for bilateral radicular pain due to known severe l5-s1 central canal stenosis.His neurological exam revealed weakness of the right tibialis posterior and toes flexors, inability to heal walk on the right, asymmetric sensory loss below both ankles, more pronounced at the sole of the right foot, absent ankle reflexes bilaterally.Electrodiagnostics showed asymmetric axonal sensorimotor polyneuropathy in lower extremities, more than 50% difference between right and left tibial compound muscle action potential, asymmetric ongoing denervation involving distal muscles bilaterally, paraspinal muscles bilaterally, and right tibial muscles distal to the hamstring branches.There were several localization possibilities to explain the patient's symptoms and electrodiagnostic findings.These included mononeuropathy multiplex, lumbosacral radiculoplexus neuropathy, and a combination of compressive radiculopathy + peripheral neuropathy + right tibial neuropath.Serological workup was unrevealing for potential etiology, except for borderline a1c.Cerebrospinal fluid showed normal protein, wbc and cytology.A nerve ultrasound showed a large, complex, right popliteal fossa cyst that abuts the tibial nerve.This was followed by magnetic resonance imaging of the right knee.It showed advanced degenerative changes, and large lobulated complex multiseptated cyst at the posterior medial aspect of the right knee joint.This was thought to be a meniscal cyst formation or large synovial cyst.Aspiration of the cyst resulted in an immediate relief of the right knee pain and foot paresthesia, and resolution of right foot weakness within 3 months.He had a right knee replacement and symptoms have not returned since.On an unknown date, the patient experienced deep venous thrombosis and right popliteal cyst.The deep venous thrombosis was medically significant.Action taken to euflexxa was unknown.On an unknown date, the outcome of deep venous thrombosis was recovered, the outcome of right popliteal cyst was recovered.The patient`s medical history was significant for: arthritis, right tibial neuropath, peripheral neuropathy, compressive radiculopathy, lumbosacral radiculoplexus, mononeuropathy multiplex and severe l5-s1 central canal stenosis.The patient`s procedures included neurological exam, nerve ultrasound, knee replacement, magnetic resonance, and electrodiagnostics.No concomitant medication was reported.The event deep venous thrombosis was reported as serious.The event right popliteal cyst was reported as non-serious.At the time of reporting the case outcome was recovered.Overall listedness (core label) is unlisted.Reporter causality: not provided company causality: unassessable other case numbers: case number, others = (b)(4); case number, others = (b)(4); case number, others = (b)(4).This ae occurred in the us and concerns the medical device sodium hyaluronate.Please report to your local health authority if required by local law.This ae is not reportable in eu because it did not occur in a (b)(6) country and did not result in a corrective action by the manufacturer.No corrective action was done by the manufacturer or requested by regulators.

• Brand Name: EUFLEXXA
• Type of Device: 1% SODIUM HYALURONATE
• Manufacturer (Section D): BIO-TECHNOLOGY GENERAL (ISRAEL) LTD.; be'er tuvia industrial zone; pob 571; kiryat malachi, 83104 ; IS 83104
• Manufacturer (Section G): BIO-TECHNOLOGY GENERAL (ISRAEL) LTD.; be'er tuvia industrial zone; pob 571; kiryat malachi, 83104 ; IS 83104
• Manufacturer Contact: 100 interpace parkway; parsippany, NJ 07054 ; 9737961600
• MDR Report Key: 7461140
• MDR Text Key: 106586800
• Report Number: 3000164186-2018-00012
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/25/2018

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
• Device Catalogue Number: 6301182010
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/02/2018
• Initial Date FDA Received: 04/25/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 65 YR