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

Catalog Number VS-404

Device Problem Biocompatibility (2886)

Patient Problems Abscess (1690); Bacterial Infection (1735); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Rash (2033); Swelling/ Edema (4577)

Event Date 03/25/2024

Event Type  Injury  

Event Description

On (b)(6) 2024 a physician used a venaseal closure system during treatment of a soft tissue lesion in the patients left distal great saphenous vein (gsv).78cm of vein was treated.There were no abnormalities reported in relation to anatomy.Only one leg was treated.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.There are no known co-morbidities.75 days post procedure, patient appears to have a suspected hypersensitive reaction to venaseal.On 25-mar-2024 patient developed a sore on lower portion of the leg treated with venaseal.On 29-mar-2024 when the patient came in for a follow up he had developed a second sore just below the first sore.There was also swelling present in the treated leg as seen from ultrasound and ct imaging, with the ct imaging referencing abscesses and edema.The patient admitted to picking at the sore and puss came from the sore.The clinician swabbed the sore to have it cultured and it came back positive for staph.Patient was treated with prednisone 12 day taper 30mg day 1-4, 20mg day 5-8, 10mg day 9-12; augmentin q12h for 14 days, doxycycline hyclate twice daily fo r 14 days.Issue is still present.

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.

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.

• 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: 19086465
• MDR Text Key: 339884630
• Report Number: 9612164-2024-01735
• 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
• Report Date: 04/11/2024

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: 73037
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/04/2024
• Initial Date FDA Received: 04/11/2024
• Date Device Manufactured: 07/18/2023
• 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: 73 YR
• Patient Sex: Male
• Patient Weight: 86 KG