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

Device Problems Biocompatibility (2886); Migration (4003)

Patient Problems Pain (1994); Skin Inflammation (2443)

Event Date 09/12/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Physician used venaseal occluding device.It was reported that the first treatment was in the right great saphenous vein (gsv), with no negative reaction.The small saphenous vein was treated with venaseal and patient began to feel pain as expected.However, the pain continued to strengthen and never subsided.Patient followed up with nurse practitioner who was allegedly advised by medtronic to cut out the vein where the pain was being experienced.It is reported the pain continued after the removal and patient was prescribed with two rounds of prednisone and antibiotics for inflammation and pain.Venaseal leaked from the incision and migrated from the pain.An ultrasound confirmed inflammation and a vascular specialist diagnosed lymphedema for life.The pain continued to progress up the length of the vein.Patient reported two vascular specialists refused to treat the small saphenous vein with venaseal as they are too close to the surface and nerves, causing chronic pain in patients.Patient states venaseal continues to fragment and puncture through the skin causing debilitating pain.

• 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: 9362225
• MDR Text Key: 167765813
• Report Number: 9612164-2019-04863
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2019
• 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: 11/07/2019
• 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): Other; Required Intervention