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

Catalog Number VS-402

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Headache (1880); Tachycardia (2095)

Event Date 03/29/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that 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
• 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: 7555979
• MDR Text Key: 109616334
• Report Number: 9612164-2018-01289
• Device Sequence Number: 1
• Product Code: PJQ
• UDI-Device Identifier: 10884521539921
• UDI-Public: 10884521539921
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: VS-402
• Device Lot Number: 46164
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/04/2018
• Initial Date FDA Received: 05/31/2018
• Date Device Manufactured: 01/18/2017
• 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): Required Intervention
• Patient Age: 41 YR
• Patient Weight: 70