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 Reaction (2414)

Event Date 02/01/2017

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

Patient is reported as after partial venectomia of proximal part of both gsvs and crossectomy.The physician used a venaseal closure catheter during procedure.Endovascular adhesive closure of both great saphenous veins performed using venaseal in one session.Approximately 2 days, and approximately 19 days post procedure, no complaints were reported.Dus control was performed with no problems.Approximately 2.5 months post procedure, due to the patient¿s complaints on discomfort from the right, dus was performed.¿thickening of echo-signals along the occluded gsv from the right up to 0.28cm¿ was reported.No fever, edema, and gsv compartment intact was reported.Approximately 7 days later, spontaneous skin perforation from the right occurred.Dus control showed rupture of gsv compartment due to several granulomas along the right gsv.The patient was referred to nush for crossectomy due to proximal growth of granulomas towards deep vein system.7-8 cm of proximal part of gsv was removed and several clinical tests performed: the microbiological test was negative (no infection), histological test showed ¿necrobiosis lipoidica¿.Approximately 1 month later, the same symptoms appeared from the left.The crossectomy and partial venectomia performed.

Manufacturer Narrative

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

Manufacturer Narrative

The patient's legs were scanned with ultrasound, the patient has healed incisions where both gsvs were explanted.The ultrasound documented the absence of the gsvs.Patient is currently without symptoms and doing well.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: 6680007
• MDR Text Key: 78766776
• Report Number: 3011410703-2017-00274
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• Reporter Country Code: LO
• PMA/PMN Number: P140018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2017
• 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: 12/01/2017
• 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): Required Intervention
• Patient Age: 59 YR
• Patient Weight: 56