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

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

Patient Problem Thrombus (2101)

Event Date 09/01/2014

Event Type  Injury  

Manufacturer Narrative

Literature article: cyanoacrylate glue used to treat great saphenous reflux: measures of outcome phlebology 2017 32:2 (99-106) doi: 10.1177/0268355516638200 cine image review: the article includes a ultrasound image with shows an example of 6-month follow-up duplex showing recanalization of the previously obliterated proximal great saphenous vein as indicated on the caption.The article indicates all of the patients had symptomatic improvements post procedure, despite the fact that there were seven cases of partial recanalization on follow-up duplex.

Event Description

A study was carried out between september 2014 and october 2015 to measure the outcome of using cyanoacrylate glue to treat great saphenous reflux.Fifty-seven legs in 29 patients with primary varicose veins were included.Small stab avulsions of varicosities under local anesthesia were performed in the same operative setting.Operative complications included two minimal extension of thrombus to deep vein.Both required treatment of subcutaneous low molecular weight heparin injection for 1 week which showed completion resolution of the deep vein thrombus.

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: 6452699
• MDR Text Key: 71462439
• Report Number: 3011410703-2017-00081
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: P140018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/06/2017

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/06/2017
• Initial Date FDA Received: 04/03/2017
• Supplement Dates Manufacturer Received: 03/06/2017
• Supplement Dates FDA Received: 10/02/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 63 YR