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

Model Number VS-402

Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Granuloma (1876); Pain (1994)

Event Date 10/26/2020

Event Type  Injury  

Manufacturer Narrative

Image review: four post-procedure photographs of post-procedural images were received for review.The first two images are of the patient¿s right lower treated limb short saphenous vein, (ssv) approximately 6.5 months post procedure.Reflective masses are visible within the right short saphenous vein.The last two images are of the patients left treated limb great saphenous vein, (gsv).Reflective masses are visible within the treated left great saphenous vein.Medical affairs was contacted for review of the images.The images were determined to abnormal for a venaseal case.There appears to be a mass surrounding the ssv segment and adjacent to the vein in the gsv.The masses may be a foreign body granuloma formation, or a mixed echogenicity fluid filled mass which could be ascertained with a histologic examination.If information is provided in the future, a supplemental report will be issued.

Event Description

A physician used a venaseal closure system to treat a patient¿s great saphenous vein (gsv) and short saphenous vein (ssv).The right leg was initially treated, followed by the left 1 day later.The ifu was not followed, did not use blue sheath.No guidewire used for the insertion of the catheter.No compression used.Tumescent infiltration was not utilized.Local anaesthesia was used.There were no issues during procedure.2 segments were treated, and the vein is reported to have closed.It is reported the patient experienced pain around the treated areas after six months, none existed before then.No additional treatment was conducted.One month later the patient came in for their follow up appointment and the right ssv midcalf and the left gsv proximal thigh were of concern.The patient was complaining of leg pain and knots in these areas.Additional information received indicates the patient the patient is in no pain and does not require any further treatment.Post procedural images were received which revealed masses which may be a foreign body granuloma formation, or a mixed echogenicity fluid filled mass.

• 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: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 12049038
• MDR Text Key: 257718851
• Report Number: 9612164-2021-02439
• Device Sequence Number: 1
• Product Code: PJQ
• UDI-Device Identifier: 00643169986268
• UDI-Public: 00643169986268
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: VS-402
• Device Catalogue Number: VS-402
• Device Lot Number: 59260
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/22/2021
• Date Device Manufactured: 03/31/2020
• 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 Age: 81 YR
• Patient Weight: 88