MAUDE Adverse Event Report: MEDTRONIC IRELAND VENASEAL(TM) CLOSURE SYSTEM; AGENT, OCCLUDING, VASCULAR, PERMANENT

Model Number	VS-402
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pulmonary Embolism (1498); Pain (1994); Thrombosis/Thrombus (4440)
Date of Event	11/27/2021
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
Physician used the venaseal closure system to treat the patient¿s left great saphenous vessel (gsv).Local anesthesia was used.The lumen was flushed prior to use and a guidewire was used for insertion of the catheter.Ifu was followed.Compression was not used post procedure.The vein was closed.It was reported that an adverse event occurred after the venaseal was implanted.At follow-up 4 days after implant, no dvt was noted.Egit 1 was documented.Patient presented to the ed 8 days post implant c/o pain with deep inspiration.Ct was done 9 days after implant and pulmonary embolism (pe) noted.Venous duplex done 9 days after implant, no dvt noted.The physician has ruled out deep vein thrombosis in the patient's legs twice.No clot extension into the junction, but it is unclear if it was the sfj or spj.There is an egit 1 noted, superficial clot.The patient is alive and diagnosed with a pulmonary embolism (pe).
Additional Manufacturer Narrative
Additional information: tip was confirmed to be 5 cm from saphenofemoral junction.No information regarding any additional treatment for this patient.Received a heparin drip as an inpatient, and was discharged with apixaban.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.

• Brand Name: VENASEAL(TM) CLOSURE SYSTEM
• Common Device Name: AGENT, OCCLUDING, VASCULAR, PERMANENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 13008886
• Report Number: 9612164-2021-04858
• Device Sequence Number: 13907553
• Product Code: PJQ
• UDI-Device Identifier: 00643169986268
• UDI-Public: 00643169986268
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P140018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2022

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: 09/30/2022
• Device Model Number: VS-402
• Device Catalogue Number: VS-402
• Device Lot Number: 60907
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2021
• Supplement Date Received by Manufacturer: 01/10/2022
• Initial Report FDA Received Date: 12/15/2021
• Supplement Report FDA Received Date: 01/12/2022
• Date Device Manufactured: 09/22/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 41 YR
• Patient Sex: Male
• Patient Weight: 112 KG