MAUDE Adverse Event Report: MEDTRONIC IRELAND VENA SEAL CLOSURE SYSTEM; LASER THERAPY PRODUCT

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

Patient Problems Inflammation (1932); Thrombosis/Thrombus (4440)

Event Date 07/24/2020

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 for two procedures, 2nd procedure occurred 6 days after initial procedure (first procedure) and the second procedure.Post initial procedure to get the 2nd treatment, the patient reported that the patient was told there was inflammation in the back of the leg.The procedure was carried out successfully.A couple of days later patient had shortness of breath, and went to the er and patient was diagnosed with blood clot.The patient suspects the blood clot was there before the procedure was started.Patient stated procedure was accessed through the ankle and it was very painful.Per the patient the medical staff at the clinic stated "we cant start at the knee, it looks like there is nothing there.It is closed.We are going to do it where the ankle is at.I had it done and it was very painful.The doctor asked the tech about the on the upper part of the knee." per the patient the tech stated " we can't because it is closed".Patient was told the blood clot was where the first procedure was done.Patient reached out to a vascular surgeon for a second opinion.Encouraged patient to follow through with second opinion.Patient was informed there are risks with every procedure.No further patient injury or intervention was reported.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VENA SEAL CLOSURE SYSTEM
• Type of Device: LASER THERAPY PRODUCT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 10587775
• MDR Text Key: 208580508
• Report Number: 9612164-2020-03639
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 12/14/2020

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
• Initial Date Manufacturer Received: 09/01/2020
• Initial Date FDA Received: 09/25/2020
• Supplement Dates Manufacturer Received: 12/11/2020
• Supplement Dates FDA Received: 12/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization