MAUDE Adverse Event Report: MEDTRONIC IRELAND VENA SEAL CLOSURE SYSTEM; AGENT, OCCLUDING, VASCULAR, PERMANENT

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

Patient Problems Fever (1858); Hypersensitivity/Allergic reaction (1907); Pain (1994); Malaise (2359); Reaction (2414)

Event Date 10/31/2019

Event Type  Injury  

Manufacturer Narrative

Journal name: contact dermatitis journal title: allergic contact dermatitis with systemic symptoms caused by venaseal authors: francisco, j navarro-trivino; jorge cuenca-manteca; ricardo ruiz-villaverde year:2019 issue: 1-2 doi: 10.1111/cod.13431.If information is provided in the future, a supplemental report will be issued.

Event Description

A (b)(6) male was referred from the angiology and vascular surgery department to our contact dermatitis clinic following a skin and systemic reaction after venaseal treatment.The patient denied a personal or family history of atopic dermatitis and psoriasis and also previous contact with dermabond or other acrylate products.On the third day after venaseal treatment of the varicose vein in the right leg, the patient suffered fever of 38.5ºc and general malaise.He noted intense pain and elevated skin temperature along the vein.On the sixth day, purple nodules appeared, with subsequent fistulation and drainage of venaseal material.Subsequently, the patient attended to the emergency department, where oral antibiotic (amoxicillin 1 g every 8 hours) and analgesics were prescribed without improvement within three days.The patient did not show wheals or angioedema.Symptoms began to disappear after treatment with oral steroids (prednisone 30 mg/day) for 10 days, without recurrence.Physical examination revealed induration of the venous path, painful to compression.Hyperpigmented macula was also observed.Cutaneous ultrasound showed hyperechoic tissue around the vein, with internal hyperechoic material with posterior acoustic shadow, indicating the venaseal deposit.General biochemistry was all within normal limits.Patch tests were performed with the european comprehensive baseline series (chemotechnique diagnostics, vellinge, sweden), a methacrylate series and a venaseal ¿as is¿.The results were interpreted according to the criteria of the international contact dermatitis research group.Patch tests were read on the second day (d2) and d4.The patient only showed positive patch test reaction to venaseal ¿as is¿.No reaction to any other acrylates tested were observed.A systemic contact allergic reaction to venaseal was thus diagnosed.An appropriate treatment is being discussed in order to eliminate persistent venaseal material in the affected venous path; the patient will be scheduled for phlebectomy.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: VENA SEAL CLOSURE SYSTEM
• Type of Device: AGENT, OCCLUDING, VASCULAR, PERMANENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 9430970
• MDR Text Key: 170008543
• Report Number: 9612164-2019-05034
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P140018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2019
• 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): Required Intervention
• Patient Age: 30 YR