MAUDE Adverse Event Report: MEDTRONIC INC. VENASEAL; AGENT, OCCLUDING, VASCULAR, PERMANENT

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Dyspnea (1816); Erythema (1840); Itching Sensation (1943); Pain (1994); Peeling (1999); Rash (2033); Skin Discoloration (2074); Swelling/ Edema (4577)

Event Date 10/10/2022

Event Type  Injury  

Event Description

On october 11th and 12th, i had the venaseal procedure to reroute blood to healthy veins.A few days afterwards my legs became itchy, red, painful, and extremely swollen.I also developed rash on body, arms, legs, buttock that were itchy.I was started on a medrol dose pack but after a few days, i didn't notice any improvement.I debated going to the emergency room and regret that i did not go but instead i called the surgeon again, and i was switched to high dose of prednisone taper and prescribed some cream that had to compounded at a specialty pharmacy that was expensive.The creamed burned but it was almost a welcomed change because it was not itchy.I finally finished the prednisone taper but i still have itchiness, discoloration on my legs, pain in my legs, a feeling of heaviness in my legs when i walk, and my skin looks like it is peeling in some areas.I also developed shortness of breath and now have to take a rescue inhaler.It has been a horrible experience.The not knowing of when i will be symptom free from the venaseal procedure is worrisome.Please feel free to reach out for any additional information you may need.Fda safety report id # (b)(4).

• Brand Name: VENASEAL
• Type of Device: AGENT, OCCLUDING, VASCULAR, PERMANENT
• Manufacturer (Section D): MEDTRONIC INC.
• MDR Report Key: 15834332
• MDR Text Key: 304102107
• Report Number: MW5113376
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: BENADRYL ; EFFEXOR ; IBUPROFEN ; PEPCID; ZYRTEC
• Patient Outcome(s): Other; Disability; Required Intervention
• Patient Age: 38 YR
• Patient Sex: Female
• Patient Weight: 95 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White, Native Hawaiian Or Other Pacific Islander