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

Model Number VS-402

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Rupture (2208)

Event Date 05/22/2018

Event Type  Injury  

Manufacturer Narrative

No components from the vena seal closure system kit was received for evaluation.No sonographic images were received for evaluation.Four photographic images of the patient¿s right inner calf were provided.Image one is of the patient¿s right lower extremity inner calf just above the ankle.The dermis is peeling and red.A shallow open wound is present.Image two is of the patient¿s right lower extremity inner calf just below the knee.The dermis red and ¿three erosions through the skin¿ are present.Image three is a wide angle shot of the patient¿s right lower extremity inner calf above the ankle and just below the knee.The amount of peeling skin and redness is less severe than in image one.The open wound appears to be healed over.Redness still exists just below the knee and only one of the ¿three erosions through the skin¿ is visible.The ¿three erosions through the skin¿ appear to be healing.Image four is a close-up of the larger erosion through the skin near the right knee.The skin around the erosion exhibits swelling and redness.The images appear to be from two different follow-up visits due to the amount of healing present in images 3 and 4 when compared to the other two images.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that a patient was treated with vena seal closure system for venous insufficiency.The venaseal procedure was completed per ifu.During follow up with this patient, the physician reported the presence of 3 ¿erosions¿ through the skin (2mm in diameter) over the area of vena seal treated vein.Crystals were noted to be extruded through the skin when the skin was compressed.The crystals were removed from the eroded skin.The physician prescribed a round of corticosteroid.The physician did note that this patient did not have an infection and was in a stable condition.

Manufacturer Narrative

Patient was prescribed a medrol dosepack.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
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 7768193
• MDR Text Key: 116599323
• Report Number: 9612164-2018-02006
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Model Number: VS-402
• Device Catalogue Number: VS-402
• Device Lot Number: 50066
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/03/2018
• Date Device Manufactured: 01/11/2018
• 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 Weight: 86