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

Catalog Number VS-402

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

Patient Problems Pain (1994); Swelling (2091); Thrombus (2101); Patient Problem/Medical Problem (2688)

Event Date 06/24/2019

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Patient had 20cm of short saphenous vein (ssv) treated with venaseal closure system.During procedure, the blue sheath was not placed.Only the white catheter was used to treat ssv.Procedure completed as normal.The vein is reported to have closed.The popliteal was observed to be patent.The patient returned for a post op scan and complained of pain in the whole left limb.Moderate swelling was visualised.The patient was prescribed eliquis 5mg 3x/day.

Manufacturer Narrative

Additional information: the catheter tip was located just before the fascial curve (approximately 5cm from the saphenopopliteal junction) prior to delivery of adhesive.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: patient continues to take eloquis and will have a follow up scan if information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: follow-up ultrasound was negative for dvt.Thrombus resolved.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Image review: the first two cine images provided a view of the vessel likely prior to treatment and the second cine shows the vessel compressed and potentially closed.The third cine image showed the vessel (left popv prox) with graphics added to the image.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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: 8752470
• MDR Text Key: 149766399
• Report Number: 9612164-2019-02633
• 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,Followup,Followup,Followup
• Report Date: 10/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2020
• Device Catalogue Number: VS-402
• Device Lot Number: 53042
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/08/2019
• Date Device Manufactured: 10/01/2018
• 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: 52 YR
• Patient Weight: 78