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 Problem Patient Problem/Medical Problem (2688)

Event Date 07/27/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient had a stripping and ligation treatment of the great saphenous vein in 1995.Over the years a neovascularization occurred.The patient received a venaseal treatment in 2013 in which it appeared the adhesive was delivered into the femoral vein as well as the intended site.Following this procedure, the patient developed a strong varicosity on his leg.The patient was not willing to get a further treatment at this time and did not report back to the implanting physician.The patient then presented to another physician (dr (b)(6)) in 2018.On (b)(6) 2018, the patient had a re-crossectomy carried out and the adhesive was left in the femoral vein.This has lead to a venous statist but the patient has no clinical symptoms.

Manufacturer Narrative

No images are available.No further intervention has been carried out.Age corrected.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,gw
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway,gw
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 7854650
• MDR Text Key: 119488131
• Report Number: 9612164-2018-02324
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 11/12/2018

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: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/09/2018
• Initial Date FDA Received: 09/07/2018
• Supplement Dates Manufacturer Received: 10/17/2018
• Supplement Dates FDA Received: 11/12/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Weight: 70