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

Catalog Number	VS-402
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fever (1858); Patient Problem/Medical Problem (2688)
Date of Event	10/31/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A patient was treated for venous insufficiency using venaseal treatment.A 90 cm segment of the gsv and a 14 cm segment of the ssv were closed using venaseal.A 3.8 cm of product was used.The ifu was followed with no issues identified.One week post implant the patient had a temperature of 99 degrees.Patient does not appear to have allergies.Patient was prescribed keflex and pain pills.The patient had an infected varicosity removed.The patient has a wound vac and is scheduled to leave the hospital soon.

• Brand Name: VENA SEAL CLOSURE SYSTEM
• Common Device Name: AGENT, OCCLUDING, VASCULAR, PERMANENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 7078657
• Report Number: 9612164-2017-01711
• Device Sequence Number: 19083812
• Product Code: PJQ
• UDI-Device Identifier: 10884521539921
• UDI-Public: 10884521539921
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P140018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/04/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: VS-402
• Device Lot Number: 46228
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2017
• Initial Report FDA Received Date: 12/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 49 YR
• Patient Weight: 115