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

Model Number VS-404

Device Problem Biocompatibility (2886)

Patient Problems Granuloma (1876); Pain (1994); Local Reaction (2035); Swelling/ Edema (4577); Insufficient Information (4580)

Event Date 09/22/2022

Event Type  Injury  

Event Description

A patient was treated with venaseal in three vessels on separate occasions of treatment - left great saphenous vein (gsv) 60 cm, right gsv 38 cm, right short saphenous vein 18 cm.The ifu was not followed, vessels were treated during 3-minute hold.The lumen was flushed prior to use.It was reported post procedure patient is experiencing "spots" of redness, pain, swelling, and sometimes oozing.Both legs.Appears to have started on the left leg distal thigh and mid-calf.There is now a spot on the right posterior calf as well.The patient has venous insufficiency (chronic) (peripheral), localised edema (not elsewhere classified), and myositis; foreign body granuloma of soft tissue, not elsewhere classified, left lower leg.The physicians plan to continue clindamycin prescription and to discontinue norvasc due to persistent swelling.The physician plans to excise the left leg granuloma.Monitor blood pressure and follow diet.5 months post left leg treatment the patient had an early follow-up due to o recurrent redness induration l leg distal thigh/mid-calf.Initial improvement with clindamycin but has recurred.Has 2 other small red indurated spots on r calf.Swelling has improved off norvasc.Venous insufficiency (chronic) (peripheral).Localised edema still present.Myositis: foreign body granuloma of soft tissue, not elsewhere classified, left thigh and myositis; foreign body granuloma of soft tissue, not elsewhere classified, right lower leg.The physicians plan from the (b)(6) 2022, patient to restart clindamycin 300mg tid x 10d.Scheduling granuloma excision.Patient is having an adverse event.Fbr (foreign body rejection).Localized areas where vein was very superficial.Granuloma keeps arising cause redness, pain, and swelling at sites.No further patient injury reported for this event.

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.

Manufacturer Narrative

Additional information - - early f/u due to recurrent redness induration l leg distal thigh/mid calf.Initial improvement with clindamycin but has recurred.Has 2 other small red indurated spots on r calf.Swelling has improved off norvasc - meds and records rev/discussed.Patient took all take medications as prescribed.Restart clindamycin 300mg tid x 10d granuloma excision at a clinic 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

Image analysis one image was returned for review.The image is a black and white photo of the patients left leg.There are two areas of discoloration, with what appears to be small dark scars or depressions in the center.One is on the medial side of the knee.The other area of discoloration is halfway between the knee and medial malleolus.Due to the lack of color, and nature/quality of the photo, it is difficult to confirm the reported patient experience of granulomas and spots of redness, pain, swelling and oozing, however there does appear to be a reaction site event.An additional report on pg2 remarks a complication of vasospasm of the knee, this could not be confirmed.There is no indication from the images attached that the vena seal device caused the reaction on the patients leg.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 ; 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: 15841976
• MDR Text Key: 304096792
• Report Number: 9612164-2022-04357
• Device Sequence Number: 1
• Product Code: PJQ
• UDI-Device Identifier: 00763000240776
• UDI-Public: 00763000240776
• 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,Followup,Followup
• Report Date: 01/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: VS-404
• Device Catalogue Number: VS-404
• Device Lot Number: 66373
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2022
• Date Device Manufactured: 01/07/2022
• 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
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 120 KG