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

Catalog Number VS-402

Device Problem Biocompatibility (2886)

Patient Problems Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Pain (1994); Swelling (2091); Reaction (2414); Skin Inflammation (2443)

Event Date 11/01/2017

Event Type  Injury  

Manufacturer Narrative

Event date: month and year valid.Implant date: month and year valid.If information is provided in the future, a supplemental report will be issued.

Event Description

Patient underwent bilateral great saphenous vein (gsv) treatment.10 days post index procedure the had patient presented with swelling, erythema, and pain and was treated with antihistamines.Approximately 2 years post venaseal implant the patient experienced the same symptoms of swelling, erythema, and pain and was treated with antibiotics for 10 days by a family doctor.Patient visited a vein clinic approximately 3 years and 4 months post venaseal implant presenting with symptoms of swelling, erythema, and pain in superficial segment of the gsv.The patient was treated with antihistamines to treat the pain and tenderness and the symptoms resolved in 3 days.

Manufacturer Narrative

Additional information: the patient complained of varicose veins of both legs, where there was swelling and night cramps.The patient was diagnosed with venous insufficiency.The physician planned to treat with venaseal.The physician conducted a duplex ultrasound and found the id to be to be 7.2mm and 5.1 mm, with varicose veins of the lateral branches, swelling of both legs.Procedure was successful, the procedure and immediate postoperative period had no issues.The patient was in good general condition the next day and was discharged from the hospital for further outpatient rehabilitation.The physician prescribed bandages and control in bkv, repeated control in keb, and medication of powder nimesi twice daily for 7 days, 2 detralex daily for 2 months, xarelto daily for 5 days.For when allergic reactions appear on the skin along the veins, the patient was prescribed rupafin daily for 7 days.The patient noticed a thickened vein in lower leg from the venaseal treatment about 4 months and 6 months later.The patient had returned back to the same hospital about 25 months after the procedure, with complaints of being ill with acute respiratory viral infection (arvi) 3 weeks prior, where antibiotics were prescribed.It was concluded that, from the venaseal procedure, there was varicose vein of the abu kaju reticular vein.The physician performed a foam sclerotherapy on both feet with aethoxysclerol (0.5%).The procedure for both legs were teleangiectasis.The procedure was reported to be successful.No thrombotic mass was noted in the lumen.The patient went to another clinic about 13 months later, where the physician there had marked vein in red where plar was observed.According to the physician, the patient had swelling, erythema, and pain.The patient was treated with antihistamines and nsaids for 3 days and the symptoms were reported to have disappeared.The physician has planned another examination to see how the patient is currently doing.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: the antihistamines were prescribed.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: VENA SEAL CLOSURE SYSTEM
• Type of Device: AGENT, OCCLUDING, VASCULAR, PERMANENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 9705230
• MDR Text Key: 179425364
• Report Number: 9612164-2020-00701
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• PMA/PMN Number: P140018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: VS-402
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Weight: 75