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

Model Number VS-404

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

Patient Problems Cyst(s) (1800); Purulent Discharge (1812); Erythema (1840); Unspecified Infection (1930); Pain (1994); Phlebitis (2004); Swelling/ Edema (4577)

Event Date 01/27/2023

Event Type  Injury  

Event Description

A venaseal closure system was used for treatment of 1 segment of the great saphenous vein (gsv).The ifu was followed.Compression was used and the vein closed.No challenges to the location of the catheter tip prior to initial delivery of adhesive.The catheter tip was positioned 5cm caudal to sfj with no challenges.The patient reported via the medtronic website that the patient has welts and cyst type wounds and the procedure had been over 3 and 1/2 months ago.Date of on-set symptoms was one month post-op.Only one leg was treated.The physician reported seeing the patient 1 month post op for r leg pain, edema, pus and erythema and at that time prescribed patient antibiotics which improved her condition.Ultrasound was performed as well and no dvt found.Patient was then seen again for return of symptoms where ultrasound noted there was phlebitis from a branch coming off gsv.Patient was prescribed steroids and antibiotics and again the symptoms cleared but not fully.Patient was sent to wound care and also infectious disease.The patient has been undergoing chemotherapy for breast cancer.Excision has been discussed as option to alleviate patient symptoms.The issue still present.Culture was taken and no infection was present.The patient was scheduled to consult with a vascular surgeon for explant.

Manufacturer Narrative

Image analysis: one image was provided for analysis.The image is of the patient's leg.The image is not dated, however, from the information provided by the account, is post venaseal procedure.There appears to be 4 raised wounds/eschars in a linear pattern on the skin between the knee and ankle.1 of the eschars has been covered with a band-aid.There is yellow and red discolouration around each eschar.There are smaller areas of dried and cracking skin between each eschar.The reported event can be confirmed.There is no indication from the images attached of an issue with a venaseal device or malfunction 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.

Manufacturer Narrative

Additional information received reported that redness was seen a few days after the index procedure.When they visited the er to get treated, she ended up getting covid.She was treated with prednisone, which helped her reaction and stopped the redness.One month post index welts formed, and white stuff like the glue were coming out.Ulcer formed 2 moths later and venaseal was explanted 5 months post index.The patient continue to have liquid oozing out and redness in the area 3-4 cm from the access site.10 days ago, she was in the er and treated with antibiotics for an infection.Patient¿s leg is still swollen and aching; hurts more when standing.Patient is continuing to get treatment and has developed scar from the venaseal complication.The patient had two biopsies; one completed at another institution and the other done when she had her vein explanted.Specimen pathology: varicose vein with acute thrombophlebitis, foreign body type giant cell reactions, marked acute and chronic inflammation.Soft tissue report: soft tissue showing ne crotizing granulomatous inflammation with foreign body type giant cell reactions and marked acute and chronic inflammation 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: symptoms include inflammation and welts all along the path of the treated vein from calf to upper thigh 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

Update received reported that the physician that the patient's vein was excised 2 weeks prior.No further information has been available regarding patient status.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.

Event Description

A venaseal closure system was used for treatment of 1 segment of the great saphenous vein (gsv) on the (b)(6) 2022.The ifu was followed.Compression was used and the vein closed.No challenges to the location of the catheter tip prior to initial delivery of adhesive.The catheter tip was positioned 5cm caudal to sfj with no challenges.The patient reported via the medtronic website that the patient has welts and cyst type wounds and the procedure had been over 3 and 1/2 months ago.Date of on-set symptoms was one month post-op ((b)(6) 2022).Only one leg was treated.The physician reported seeing the patient 1 month post op for r leg pain, edema, pus and erythema and at that time prescribed patient antibiotics which improved her condition.Symptoms include inflammation and welts all along the path of the treated vein from calf to upper thigh.Ultrasound was performed as well and no dvt found.Patient was then seen again on (b)(6) 2023 for return of symptoms where ultrasound noted there was phlebitis from a branch coming off gsv.Patient was prescribed steroids and antibiotics and again the symptoms cleared but not fully.Patient was sent to wound care and also infectiou s disease.The patient has been undergoing chemotherapy for breast cancer.Excision has been discussed as option to alleviate patientsymptoms.Update: (b)(6) 2023: the issue still present.Culture was taken and no infection was present.Update: (b)(6) 2023: the patient was scheduled to consult with a vascular surgeon for explant on (b)(6) 2023.Update received (b)(6) 2023: physician that the patient's vein was excised 2 weeks prior, even though the physician advised the patient 2 months prior to have it excised.No further information has been available regarding patient status.

Manufacturer Narrative

Correction of the aware date of follow up number: 002 (regulatory rep #:9612164-2023-01265)-aware date : 27-apr-2023.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 received reported that the patient is still experiencing minor inflammation in the lower legs, relatively less than before the vein excision.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: VENA SEAL CLOSURE SYSTEM
• Type of Device: AGENT, OCCLUDING, VASCULAR, PERMANENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway,ie ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway,ie ; EI
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 16616778
• MDR Text Key: 312007382
• Report Number: 9612164-2023-01265
• Device Sequence Number: 1
• Product Code: PJQ
• 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,Followup
• Report Date: 09/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: VS-404
• Device Catalogue Number: VS-404
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/22/2023
• 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
• Patient Age: 56 YR
• Patient Sex: Female