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

Catalog Number VS-404

Device Problem Biocompatibility (2886)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 03/12/2024

Event Type  Injury  

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

On (b)(6) 2024 a physician used a venaseal closure system during treatment of a patients right great saphenous vein (gsv).65cm of vein was treated.There were no abnormalities reported in relation to anatomy.Hypersensitivity outside the treatment area (not the axial vein) was reported post-op.This was an initial reaction event.The blue introducer was used.There were no challenges or deviations related to location of catheter tip prior to initial delivery of adhesive.The catheter tip was 5cm caudal to sfj.There are no known co-morbidities.Patient was treated with benadryl, methylprednisolone x 2.Issue is still present.

Manufacturer Narrative

Additional information: onset of symptoms started on the 2024-mar-16.The right leg was treated, right sfj to ankle.Compression of the gsv was applied.Reported degree of tortuosity is not tortuous.Patient condition improving but not completely resolved as of 4/4 but was offered longer prednisone taper but refused the treatment.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Manufacturer Narrative

Additional information: physician resected the gsv.Patient came back with positive skin test confirming allergic to cyanoacrylate.Image review one film image was returned for review.Surgical specimen appears to be an explanted great saphenous vein.There appears to be some areas where a darker tan/brown material which is/was intraluminal ¿ based upon history, this may be the polymerized venaseal no other comment regarding the surgical specimen, other than the vein appears to have been removed as a single lengthy vein specimen, curious about how this was done ( technique specifics) the explant of the vein occurred approximately 2 months after the procedure ¿ the history states 2 rounds of benadryl and oral steroid (no dosage provided) occurred.Patient refused longer steroid pharmacotherapy.Physician opted for explant at that point positive skin test for allergy to cyanoacrylate specific symptoms patient experienced are not related no histology report provided on specimen at this point medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• 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: 19049056
• MDR Text Key: 339435314
• Report Number: 9612164-2024-01621
• 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
• Report Date: 04/16/2024

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
• Device Catalogue Number: VS-404
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/29/2024
• Initial Date FDA Received: 04/05/2024
• Supplement Dates Manufacturer Received: 04/08/2024
• Supplement Dates FDA Received: 04/16/2024
• 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
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 95 KG