MAUDE Adverse Event Report: COVIDIEN CLOSUREFAST CATHETER; ELECTROSURGICAL, CUTTING & COAGULATION & ACCES

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

Patient Problems Pulmonary Embolism (1498); Stroke/CVA (1770); Thrombosis/Thrombus (4440)

Event Date 10/01/2021

Event Type  Injury  

Event Description

A journal article was submitted presenting a review of the current literature reporting the thrombotic complications associated with current thermal and non-thermal techniques.The article reports related to radiofrequency ablation, clinical events of thrombosis in the superficial vein which can lead to phlebitis, or potentially propagate thrombus formation towards the deep venous system, resulting in a deep vein thrombosis (dvt), and points out these events have potential for pulmonary embolism (pe).The authors report from the review of current literature that initial rates for dvt after rfa treatment were as high as 16%, however more recent literature report lower rates ranging from 0.7-3.4%.A study reviewed which reported 192 patients underwent rfa with a dvt rate of 3.4% at 30-days.The authors report pulmonary embolism as a complication secondary to dvt after rfa is rare and the literature largely consists of case reports but has been reported at a rate of 0.03-0.2%.The article reports that related to the venaseal closure system dvt has also been shown to be a potential complication.The authors report how there can be extension of cyanoacrylate into the deep venous system during the procedure, and it is theorized that this extension of adhesive may induce thrombosis.A cohort study which included 70 patients that underwent venaseal¿ ablation, did not report any serious adverse effects such as dvt or pe.Later studies have shown rates of thrombotic events, ranging from 0-13%.A retrospective review which included 191 patients, reported dvt in 11 patients (5.8%) and another retrospective review of 76 patients reported a dvt rate of 13%.Despite these reports, the largest randomized controlled trial to date, performed comparing rfa and venaseal¿, reported no treatment-associated dvts in 108 patients treated with venaseal¿ within 3-months.This wide range of thrombotic complication rates highlights the need for further large-scale investigation and standardization of follow-up protocol.

Manufacturer Narrative

Title: thrombotic complications of superficial endovenous ablation: a contemporary review of thermal and non-thermal techniques author: mariya s.Kochubey, sammy s.Siada, megan tenet journal: the journal of cardiovascular surgery year: 2021 vol/issue: 62(5) ref: 10.23736/s0021-9509.21.11898-1.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CLOSUREFAST CATHETER
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCES
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 13617376
• MDR Text Key: 290971646
• Report Number: 2183870-2022-00066
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111887
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2022
• 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
• Date Manufacturer Received: 02/01/2022
• 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): Hospitalization