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

Model Number VS-404

Device Problems Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Purulent Discharge (1812); Unspecified Infection (1930); Muscle Weakness (1967); Pain (1994); Ulcer (2274); Numbness (2415); Skin Inflammation/ Irritation (4545); Swelling/ Edema (4577)

Event Date 03/16/2023

Event Type  Injury  

Event Description

A physician used a venaseal adhesive to treat the right great saphenous vein (gsv).Local anaesthesia was used.Transducer compression was used, and the vein closed.The patient returned 2 days post index for a follow-up with no complications noted.On the 8 days post index, the patient presented with chief complaint of fever and swelling on right lower leg.The patient was admitted with a cellulitis/post-operative infection of right lower extremity with purulent material out of blister.Patient stated that the skin started blistering 7 days after the venous ablation.Pain and swelling are only on the right lower leg up to right below the knee.It is hot and tender.After further evaluation patient stated they have been progressively getting generalized weakness, numbness, tingling and body aches in the upper and lower extremities for the past 2 months with recurrent falls.Patient is on iv antibiotics, receiving wound care and will follow up with vascular clinic when discharged.Physician states patient¿s leg is improving and plans to keep the patient on antibiotics for 1 month.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

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: the patient initial had venaseal treatment of the left gsv (b)(6), 2023.No challenges or deviations related to, location of catheter tip prior to initial delivery of adhesive.The catheter tip was 5cm caudal to sfja.At the time the doc mistook the catheter tip to be at the sfj, but it was further up into the cfv above the junction.Compression of gsv was carried out.Was more than one leg treated.Only left gsv was treated.Sterile techniques were followed.The patient reported no chest pain, no shortness of breath when walking or laying down, no palpitations, no lightheadedness or ankle swelling on the day of left gsv treatment.2 days later ((b)(6), 2023) post ablation duplex ultrasound showed left lower extremity venous occlusive heterogenous intraluminal echogenicity in the common femoral vein above great saphenous vein junction and external iliac vein.Distal inferior vena cava was patent.They were unable to scan left common iliac vein due to overlying loops of bowel.The rest of the veins were compressible and color-filled.Left great saphenous demonstrated no color or spectral doppler.1 week post ablation ((b)(6), 2023).The physician saw the patient for follow up visit and started on eliquis dvt/pe treatment 30-day starter 5mg in dose pack.1 tab/2 times per day for 30 days.2 weeks later ((b)(6), 2023) follow up ultrasound was done.There still remained some heterogeneous echogenicity in the common and external iliac veins, however there is no evidence of occlusion or extension of the previously documented deep vein thrombosis.Successful venaseal ablation of the gsv.Recanalization documented.1 week later ((b)(6), 2023) the patient visited the physician, reports no chest pain, no shortness of breath when walking or laying down, no palpitations, no lightheadedness or ankle swelling.Patient to continue oral anticoagulants for a duration of 3 months and continue asa.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: 16663157
• MDR Text Key: 312507436
• Report Number: 9612164-2023-01426
• 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: 05/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2023
• 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
• Device Lot Number: 68729
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2023
• Date Device Manufactured: 07/11/2022
• 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: 58 YR
• Patient Sex: Male