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

Model Number VS-402

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

Patient Problems Pulmonary Embolism (1498); Edema (1820); Swelling (2091)

Event Date 11/01/2016

Event Type  Injury  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

The physician used the venaseal to treat the great and short saphenous vein as per ifu.It was reported 3 weeks post procedure, the patient complained of a painful warm swelling, with purple discoloration on both legs, and burning sensation from heel to buttocks, symptoms that come and go.The patient took over the counter anti inflammatory drugs initially to alleviate symptoms.Symptoms persisted.On (b)(6) 2016 treating physician prescribed medrol dosepak (steroids).An ultrasound of the bilateral lower extremity was conducted and showed "no phlebitis, no dvt but was positive for edema in the superficial tissue." the patients symptoms have improved.Additional information received 6th dec 16: the patient contacted the physician complaining of shortness of breath with exercise, advised to attend er and was admitted with a severe pulmonary embolism ((b)(6) 2016).Additional information received 14th dec 16: the patient is improved and has been discharged from hospital.

Manufacturer Narrative

Analysis: no component of the venaseal kit was returned for evaluation.A series of five photographs were received and reviewed.Photographs one and two are of the venaseal kit labels: photo one indicates that the kit was used to treat the greater saphenous vein in the left and right legs; photo two indicates that the kit was used to treat the small saphenous vein in the right leg.Photographs three and four are of the patient¿s right leg and exhibit redness.Photograph five is of the patient¿s left leg and exhibits redness.The photographs confirm the customer experience of redness of the skin over the treated veins.A good faith effort will be made to obtain the applicable information relevant to the report.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): COVIDIEN; 951 aviation parkway; morrisville NC 27560 6228
• Manufacturer (Section G): COVIDIEN; 951 aviation parkway; morrisville NC 27560 6228
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 6192997
• MDR Text Key: 62958089
• Report Number: 2183870-2016-00744
• 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: 03/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2018
• Device Model Number: VS-402
• Device Lot Number: 43571
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/03/2016
• 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: 43 YR
• Patient Weight: 95