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

Model Number VS-402

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Skin Discoloration (2074); Swelling (2091); Thrombus (2101)

Event Date 02/08/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Physician used venaseal for treatment of the patient¿s dual saphenous vein.The procedure was completed as per ifu.20cm of vein was treated and it is reported to have closed.The patient¿s right short saphenous vein (ssv) had been treated 6 months prior to the dual saphenous vein with remarkable results.Prior to treatment the patient¿s leg did not exhibit any discoloration.Following treatment of the dual saphenous vein, the patient has experienced swelling, discoloration, dermatitis (scaling).Small ulcers are reported to have appeared on the medial ankle area.The patient developed svt and dvt on both legs, which caused the ulcers.The patient was given steroid topical lotion.The patient was given a diagnosis of vasculitis.The symptoms were treated like an infection without progress made.Doxycycline, medrol packs, and then converted to prednisone 10 mg for 6 weeks and weaned off were part of the treatment.Eloquis of recurrent dvt was also conducted.Once treated like dermatitis, some improvement has been seen.The patient is curr ently in excellent condition with no wound, just slight discoloration.No further injury reported.

Manufacturer Narrative

Image review: two images were received for evaluation.The images show redness, swelling and discoloration of the patient treated ankle.The reported complication happened post procedure treatment.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.

Manufacturer Narrative

Additional information: it is reported that the patient is currently doing well.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: 10424158
• MDR Text Key: 203478825
• Report Number: 9612164-2020-03021
• Device Sequence Number: 1
• Product Code: PJQ
• UDI-Device Identifier: 00643169986268
• UDI-Public: 00643169986268
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 09/02/2020

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
• Device Expiration Date: 08/31/2021
• Device Model Number: VS-402
• Device Catalogue Number: VS-402
• Device Lot Number: 56818
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/17/2020
• Initial Date FDA Received: 08/19/2020
• Supplement Dates Manufacturer Received: 08/26/2020; 08/27/2020
• Supplement Dates FDA Received: 08/27/2020; 09/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 100