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)

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 73-year-old man presented with a 9-year history of a recurrent ulcer on the right medial malleolus.Duplex ultrasound findings were negative for deep vein thrombosis and demonstrated an incompetent gsv and a calf perforator vein.The perforator vein fed a refluxing varicosity beneath the wound.Reflux was also found in the cfv and proximal femoral vein.He denied any history of specific allergies, specifically denying autoimmune disorders and adverse reactions to adhesives he underwent gsv and perforator vein venaseal ablation (perforator vein ablation via ca is not included in the instructions for use).The gsv treated length was 68 cm, using 25 ml of ca.Two days later, duplex ultrasound demonstrated successful gsv and perforator vein ablation.No obvious intraoperative complications such as vessel perforation or ca extravasation were noted.At 3 months of follow-up, his ulcer had healed.During that visit, he reported that 9 weeks after the index procedure, he had noted nontender erythematous subcutaneous lumps along the treated gsv.He had manually compressed these areas, resulting in skin eruption with foreign body excretion, later determined to be solidified ca fragments.On examination, he exhibited multiple superficial wounds along the gsv course and periwound erythema.He was given cephalexin, 500 mg, for 10 days, given the possible diagnosis of an infection.At 5 months of follow-up, his wounds along the gsv had healed.Nevertheless, he had gradually developed new similar wounds along the same gsv course.He reported further ca aggregate excretion via manual compression.At 8 months, he had no new wounds, and his previous ones had continued to heal.His original ulcer remained healed, and duplex ultrasound again demonstrated successful vein ablation.

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: 18837625
• MDR Text Key: 336900690
• Report Number: 9612164-2024-01095
• 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

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