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

Model Number VS-402

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

Patient Problems Pulmonary Embolism (1498); Pain (1994); Thrombosis/Thrombus (4440)

Event Date 11/27/2021

Event Type  Injury  

Manufacturer Narrative

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

Event 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).

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
• Type of Device: 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
• MDR Text Key: 282258035
• Report Number: 9612164-2021-04858
• Device Sequence Number: 1
• Product Code: PJQ
• UDI-Device Identifier: 00643169986268
• UDI-Public: 00643169986268
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 01/10/2022
• Date Device Manufactured: 09/22/2020
• 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 Age: 41 YR
• Patient Sex: Male
• Patient Weight: 112 KG