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

Device Problem Biocompatibility (2886)

Patient Problems Foreign Body Reaction (1868); Granuloma (1876); Pain (1994); Thrombosis/Thrombus (4440); Swelling/ Edema (4577)

Event Date 12/01/2023

Event Type  Injury  

Event Description

Medtronic received a literature article titled 'severe adverse reactions after cyanoacrylate endovenous ablation'.The article reported a case of a 63-year-old woman reported pain, urticaria, and edema 96 hours after great saphenous vein (gsv) ablation.Given the persistence and severity of her symptoms, she was prescribed steroids by her primary care provider 3 months after ablation.Her symptoms were only ameliorated mildly with 10 mg of oral methylprednisolone.Her right gsv ca ablation (venaseal closure system; medtronic) had been performed 9 months prior by a different provider.Her leg was treated for swelling.The gsv treated length was 54.5 cm with 20 ml of ca.She denied any history of allergies, specifically autoimmune disorders and adverse reactions to adhesives.9 months after ca, and duplex ultrasound demonstrated successful gsv closure from the saphenofemoral junction (sfj) to the above-the-knee region.However, chemically induced chronic-appearing partially occluding thrombus was seen from the sfj protruding into the common femoral vein (cfv).The gsv was incompetent below the knee.Anticoagulation therapy was considered, but she declined.The methylprednisone was tapered off; however, her symptoms recurred within 3 days after cessation.She had no skin changes while taking methylprednisone.Shortly after stopping the steroids, she developed debilitating calf pain and swelling, with hemosiderin-like discoloration and a medial calf wound.Thus, she started steroids again.The results from ca patch allergy testing were unavailable in a timely manner.She was, therefore, offered vein excision.The steroids were gradually discontinued 1 week before surgery, and endoscopic vein excision was uneventful.Thrombus was noted from the above-the-knee region into the sfj and confinements of the cfv lumen.Duplex ultrasound demonstrated foreign body evidence in the gsv from the above-the-knee area into the sfj, with partial cfv occlusion consistent with ca.Histopathologic analysis was performed.At her 2-week follow-up visit, she reported significant symptom improvement, and her calf wound had begun to heal.A follow-up duplex ultrasound demonstrated a patent cfv with no residual ca and no deep vein thrombosis.Pathologic examination demonstrated intraluminal foreign body giant cells, including vacuoles, subendothelial histiocytes, and fibroblasts, compatible with a type 4 hypersensitivity reaction.At 3 months after vein excision, her leg was asymptomatic.

Manufacturer Narrative

Ref: doi.Org/10.1016/j.Jvscit.2023.101309; 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: 18837635
• MDR Text Key: 336900915
• Report Number: 9612164-2024-01096
• 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: Literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/18/2024
• 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