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

Model Number VS-403

Device Problem Biocompatibility (2886)

Patient Problem Local Reaction (2035)

Event Date 12/12/2023

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

Physician used a venaseal closure system to treat a patient¿s great saphenous vein (gsv).The lumen was flushed prior to use.The ifu (instruction for use) was followed during preparation, procedure, post-procedure.A guidewire was used for the insertion of the catheter.Tumescent infiltration was not utilized.The procedure was completed and the vein was reported to have closed.Post op, there was an inflammatory reaction of venaseal and fragments of venaseal were removed surgically from the accessory veins.

Manufacturer Narrative

Image analysis 6 film images were returned for review.Film image 1: ¿image received of patient seemingly with a type of inflammatory reaction, consistent with the report event, lot number # of the device could not be confirmed based on the returned image.¿.Film image 2: ¿image received of patient seemingly with a type of inflammatory reaction, consistent with the report event, lot number # of the device could not be confirmed based on the returned image.¿.Film image 3: ¿image received of patient seemingly with a type of inflammatory reaction, consistent with the report event, lot number # of the device could not be confirmed based on the returned image.¿.Film image 4: ¿image received of patient seemingly with a type of inflammatory reaction, consistent with the report event, lot number # of the device could not be confirmed based on the returned image.¿.Film image 5: ¿image received of patient seemingly with a type of inflammatory reaction, consistent with the report event, lot number # of the device could not be confirmed based on the returned image.¿.Film image 6: ¿image received of patient seemingly with a type of inflammatory reaction.It is seemingly evident that a piece of adhesive is erupting from the skin of the patient, consistent with the report event, lot number # of the device could not be confirmed based on the returned image.¿.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 received reported that onset of symptoms occurred 5 days post procedure.The venaseal was explanted 2 months post index (b)(6) 2024.Anesthesia was used was local with sedation.There was no challenges or deviations related to location of catheter tip prior to initial delivery of adhesive.Compression was used.The issue is still present and posted surgery for complete exploration will be performed 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: VENASEAL 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: 18997917
• MDR Text Key: 338877040
• Report Number: 9612164-2024-01510
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• Reporter Country Code: TC
• PMA/PMN Number: P140018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/23/2024

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 Expiration Date: 04/30/2024
• Device Model Number: VS-403
• Device Catalogue Number: VS-403
• Device Lot Number: 67574
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/28/2024
• Supplement Dates Manufacturer Received: 04/17/2024; 04/22/2024
• Supplement Dates FDA Received: 04/23/2024; 04/23/2024
• Date Device Manufactured: 04/08/2022
• 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