MAUDE Adverse Event Report: GALDERMA Q-MED AB DUROLANE; ACID, HYALURONIC, INTRAARTICULAR

Lot Number UNKNOWN

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

Patient Problems Rash (2033); Skin Discoloration (2074); Obstruction/Occlusion (2422); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Pharmacovigilance comments: the serious event of vascular occlusion was considered expected and possibly related to the treatment.Serious criteria included the need for hospitalization and medical intervention to prevent permanent damage.The non-serious, expected events of pain and rash at the injection site, and the unexpected event of livedo reticularis were considered possibly related to the treatment.The likely root cause includes intravascular filler injection leading to vascular occlusion and secondary events of livedo racemosa, pain and rash at injection site.Potential contributory factor includes injection technique.The product was used off label.This case meets the criteria of seriousness and causality for expedited reporting to the regulatory authorities.Engineering evaluation: no corrective or preventive actions are deemed necessary based on the outcome of the performed investigations.Routine investigations have been performed and provide sufficient information to assess the potential root cause.Lot number was not reported and the product could not be verified.The information in this case does not indicate a non-conforming product or malfunction.The performed investigations are therefore considered adequate and no additional investigations will be conducted.

Event Description

Case reference number (b)(4) is a spontaneous literature report received on 16-apr-2021.Toussi a, ma c, tartar dm.Livedo racemosa secondary to hyaluronic acid injection.Dermatol-online-j 2020;26(10):a94.We describe the first reported case, to the best of our knowledge, of livedo racemosa (lrc) secondary to vascular occlusion from an intraarticular ha injection for ankle osteoarthritis.We present a patient with ankle osteoarthritis who developed an asymmetric, reticular, livedoid eruption after intraarticular injection with hyaluronic acid.She was diagnosed with livedo racemosa secondary to vascular occlusion and placed on low-molecular weight heparin.Later, a transition to low-dose daily aspirin maintained the improvement.Case report: a (b)(6)-year-old woman presented to the emergency room with a three day history of a progressively worsening burning, painful rash on her right foot.Twelve hours prior to the onset of her rash, she had received a high concentration hyaluronic acid injection (durolane) in her right ankle for long-standing osteoarthritis, for which she had previously tolerated low concentration ha.Her examination was notable for non-palpable, non-blanching, broken-net retiform purpura, extending from the plantar aspect of her right foot to her ankle.She was diagnosed with iatrogenic livedo racemosa (lrc) secondary to vessel occlusion from ha.Laboratory workup (blood count, sedimentation rate, prothrombin time, and partial thromboplastin time) was unremarkable.Ankle-brachial index was within normal limits.Upon admission, she was placed on a heparin drip with noted improvement.Heparin was continued throughout her hospitalization for a total of three days.At discharge, she was started on enoxaparin 60mg daily for 14 days and 300mg pentoxifylline three times daily to prevent necrosis.She continued to improve on this therapy for two months, at which time she was transitioned to aspirin 81mg daily.At three months of follow-up, the livedo pattern had improved after treatment with heparin, enoxaparin, pentoxifylline and aspirin.She continued on low-dose 81mg aspirin daily.In our case, the patient presented with broken-net retiform purpura, indicating a diagnosis of lrc over lr.As a result, to our knowledge, ours is the first to describe lrc in the setting of ha mediated vascular occlusion within the ankle in the setting of osteoarthritis.The patient presented three days after the incident and was therefore no longer a candidate for hyaluronidase treatment.Instead, she was immediately started on reperfusion therapy with heparin.When her lrc improved with no evidence of continued ischemia, she was transitioned to enoxaparin and pentoxifylline.She was eventually transitioned to low-dose daily aspirin, which she continued to take with improvement.Based on cases of facial and intra-articular ha occlusion, time to recovery for these patients can range from four weeks to 6 months.

Event Description

Case reference number (b)(4) is a spontaneous literature report received on 16-apr-2021.Toussi a, ma c, tartar dm.Livedo racemosa secondary to hyaluronic acid injection.Dermatol-online-j 2020;26(10): a94.We describe the first reported case, to the best of our knowledge, of livedo racemosa (lrc) secondary to vascular occlusion from an intraarticular ha injection for ankle osteoarthritis.We present a patient with ankle osteoarthritis who developed an asymmetric, reticular, livedoid eruption after intraarticular injection with hyaluronic acid.She was diagnosed with livedo racemosa secondary to vascular occlusion and placed on low-molecular weight heparin.Later, a transition to low-dose daily aspirin maintained the improvement.Case report: a 72-year-old woman presented to the emergency room with a three day history of a progressively worsening burning, painful rash on her right foot.Twelve hours prior to the onset of her rash, she had received a high concentration hyaluronic acid injection (durolane) in her right ankle for long-standing osteoarthritis, for which she had previously tolerated low concentration ha.Her examination was notable for non-palpable, non-blanching, broken-net retiform purpura, extending from the plantar aspect of her right foot to her ankle.She was diagnosed with iatrogenic livedo racemosa (lrc) secondary to vessel occlusion from ha.Laboratory workup (blood count, sedimentation rate, prothrombin time, and partial thromboplastin time) was unremarkable.Ankle-brachial index was within normal limits.Upon admission, she was placed on a heparin drip with noted improvement.Heparin was continued throughout her hospitalization for a total of three days.At discharge, she was started on enoxaparin 60mg daily for 14 days and 300mg pentoxifylline three times daily to prevent necrosis.She continued to improve on this therapy for two months, at which time she was transitioned to aspirin 81mg daily.At three months of follow-up, the livedo pattern had improved after treatment with heparin, enoxaparin, pentoxifylline and aspirin.She continued on low-dose 81mg aspirin daily.In our case, the patient presented with broken-net retiform purpura, indicating a diagnosis of lrc over lr.As a result, to our knowledge, ours is the first to describe lrc in the setting of ha mediated vascular occlusion within the ankle in the setting of osteoarthritis.The patient presented three days after the incident and was therefore no longer a candidate for hyaluronidase treatment.Instead, she was immediately started on reperfusion therapy with heparin.When her lrc improved with no evidence of continued ischemia, she was transitioned to enoxaparin and pentoxifylline.She was eventually transitioned to low-dose daily aspirin, which she continued to take with improvement.Based on cases of facial and intra-articular ha occlusion, time to recovery for these patients can range from four weeks to 6 months.

Manufacturer Narrative

Removed health effect code for life threatening event per manufacturer review.

• Brand Name: DUROLANE
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): GALDERMA Q-MED AB; seminariegatan 21; uppsala, SE-75 228; SW SE-75228
• MDR Report Key: 11798713
• MDR Text Key: 259997934
• Report Number: 9710154-2021-00028
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• PMA/PMN Number: P170007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 05/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 72 YR