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

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Inflammation (1932); Pain (1994); Blood Loss (2597)

Event Date 09/12/2018

Event Type  Injury  

Event Description

Reporter stated she had her first injection on right great saphenous vein (b)(6) 2018 and reporter did not have any negative reactions.The small saphenous vein was injected with the venaseal on (b)(6) 2018 and caller immediately began to feel pain as expected.However, the pain continued to strengthen and never subsided.Caller followed up with nurse practitioner who was advised by medtronic to cut out the vein where the pain was experience.The pain continued after the removal, caller was prescribed two rounds of prednisone and antibiotics for inflammation and pain.Venaseal leaked from the incision and migrate from the pain.Caller had an ultrasound which confirmed inflammation, vascular specialist informed caller she is diagnosed with lymphedema for life.The pain continued to progress up the length of her vein.The two vascular specialists explained they believe medtronic is under reporting patient negative reactions from venaseal.They refuse to inject the small saphenous vein as they are too close to the surface and nerves, causing chronic pain in patients.Reporter states venaseal continues to fragment and puncture through her skin and cause debilitating pain.She wishes to inform patients, providers, and medtronic to make it a priority to have a patch test prior to injections.

• Brand Name: VENASEAL CLOSURE SYSTEM
• Type of Device: AGENT, OCCLUDING, VASCULAR, PERMANENT
• Manufacturer (Section D): MEDTRONIC IRELAND ; EI
• MDR Report Key: 9225877
• MDR Text Key: 163780233
• Report Number: MW5090590
• 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: 10/22/2019

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/22/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1