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

Catalog Number VS-403

Device Problem Biocompatibility (2886)

Patient Problems Erythema (1840); Pain (1994); Phlebitis (2004); Local Reaction (2035); Swelling/ Edema (4577)

Event Date 01/15/2024

Event Type  Injury  

Event Description

A physician used a venaseal closure system to treat 61cm of a patients right great saphenous vein (groin to internal condyle, internal condyle puncture) and 28cm of the small saphenous vein (popliteal to lateral condyle, lateral condyle puncture).The ifu was followed during preparation, procedure, post-procedure.The lumen was not flushed prior to use.A guidewire was used during catheter insertion and placement.Tumescent infiltration was not utilized.Local anesthesia was used.No compression was used.Occlusion of the right gsv and right ssv were confirmed.No additional treatment required.Approximately 1 week post procedure swelling and redness of the right lower extremity appeared.A medical consultation was made and a phlebitis diagnosis was given due to allergy with adhesive materials and oral fexofenadine (60mg x 2 times/day for 29 days) was administered.Approximately 1 month later the redness and swelling of the right lower limb had almost disappeared.Further left leg varicose vein surgery was performed, the physician used a venaseal closure system to treat a patient¿s left great saphenous vein (groin to internal condyle, internal condylar puncture) and small saphenous vein (popliteal to external condyle, external condyle puncture).A few weeks after treatment of the left leg, approximately 3 months after treatment of the right leg, the patient began to experience right lower limb pain and it became difficult to walk.The patient's progress was monitored, but the pain from the lower right thigh to the upper lower leg did not improve.Right great saphenous vein resection was performed, resection of anterior varicose vein of lower leg (4 area) and posterior surface varicose vein in lower leg (1 area).

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.

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: VENASEAL 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: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 18693258
• MDR Text Key: 335186406
• Report Number: 9612164-2024-00740
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P140018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: VS-403
• Device Lot Number: 71463
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2024
• Date Device Manufactured: 03/07/2023
• 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