MAUDE Adverse Event Report: COVIDIEN LLC VENA SEAL CLOSURE SYSTEM; AGENT, OCCLUDING, VASCULAR, PERMANENT

Catalog Number VS-402

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

Patient Problem Pulmonary Embolism (1498)

Event Date 11/14/2016

Event Type  Injury  

Event Description

It was reported that the physician used a venaseal closure system during a procedure to treat the great saphenous vein.A guidewire was used for insertion of the catheter.The vein was reported to have closed.Approximately one month post procedure, the patient complained of chest pain and shortness of breath.An ultrasound was performed approximately 5 weeks post the procedure and this showed no dvt and a closed great saphenous vein on the left limb.A ct scan was ordered and this confirmed the presence of a pulmonary embolism.The patient was treated and was placed on long term anticoagulation, xarelto.It was reported that the patient had taught a spin class the day after the venaseal treatment.It was reported that the patient refused to have a post-op ultrasound because the physician had informed him that this was not required.

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): COVIDIEN LLC; 951 aviation parkway; morrisville NC 27560
• Manufacturer (Section G): COVIDIEN LLC; 951 aviation parkway; morrisville NC 27560
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 6253613
• MDR Text Key: 64886462
• Report Number: 3011410703-2017-00004
• 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,consum
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/19/2016

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 Catalogue Number: VS-402
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/19/2016
• Initial Date FDA Received: 01/16/2017
• Supplement Dates Manufacturer Received: 12/19/2016
• Supplement Dates FDA Received: 09/28/2017
• 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: 59 YR
• Patient Weight: 73