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	Headache (1880); Tachycardia (2095)
Date of Event	03/29/2018
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
It was reported that a patient was treated with venaseal to close a diseased great saphenous vein(gsv).The procedure was prepared as per ifu and the procedure was completed as normal.A few hours post procedure, the patient experienced headaches and tachycardia.Patient has reported experiencing these events in the past, but this time the symptoms were not transient.The patient had a cardiac workup, which was negative and did not have evidence of a deep vein thrombosis (dvt).The patient had no symptoms of pulmonary embolus(pe) and a ct for pe was negative.Patient had some transient phlebitis, which resolved.The patient did not have hives or redness or itching in the treatment zone or anywhere else.The patient has had an echocardiogram(ecg), stress test and has worn a holter monitor, which have been negative.Mri of the brain has also been negative.A sleep apnea study has been ordered by the patient¿s cardiologist.Cardiac palpitations and flushing episodes have continued post procedure.No rash was reported.The physician will monitor the patient closely and has prescribed an oral steroid to alleviate symptoms.

• 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: 7555979
• Report Number: 9612164-2018-01289
• Device Sequence Number: 11391027
• Product Code: PJQ
• UDI-Device Identifier: 10884521539921
• UDI-Public: 10884521539921
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P140018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/31/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: VS-402
• Device Lot Number: 46164
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2018
• Initial Report FDA Received Date: 05/31/2018
• 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: 41 YR
• Patient Weight: 70