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

Catalog Number VS-402

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Patient Problem/Medical Problem (2688)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The physician uses a venaseal to treat one segment of the right short saphenous vein (ssv).Ifu was followed.Local anesthesia and hand compressions were performed.A guidewire was used for the insertion of the catheter and the segment was closed after the procedure.It was reported that upon a follow up ultrasound visit, the physician noted adhesive was located in the right popliteal vein.The patient was placed on a blood thinner for 30 days.

Manufacturer Narrative

Additional information: catheter was 5cm from the spj prior to delivery of adhesive.The physician speculates that, as the patient was in the trendelenburg position prior to treatment, this may have led to a bloodless field where the adhesive did not have enough blood to allow for polym erization.No device or photographic images were received for evaluation.A single photograph of a sonographic image was received.The image shows a thrombus formation in the right popliteal vein.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: 8146598
• MDR Text Key: 129778477
• Report Number: 9612164-2018-03534
• 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
• Report Date: 03/12/2019

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: VS-402
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2018
• Initial Date FDA Received: 12/10/2018
• Supplement Dates Manufacturer Received: 12/17/2018; 03/08/2019
• Supplement Dates FDA Received: 01/15/2019; 03/12/2019
• 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: 87 YR