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

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

Patient Problems Foreign Body Reaction (1868); Patient Problem/Medical Problem (2688)

Event Date 04/24/2019

Event Type  Injury  

Manufacturer Narrative

Date of event: date of publication journal article title: outcomes of the chimney technique for endovascular repair of aortic dissection involving the arch branches volume 58, july 2019 zhao et al.Ann vasc surg 2019; 58: 238e247; https://doi.Org/10.1016/j.Avsg.2018.10.041.If information is provided in the future, a supplemental report will be issued.

Event Description

This article reports on a patient who was examined 5.5 years after both gsvs were treated with cyanoacrylate closure (venaseal) for chronic venous insufficiency cyanoacrylate closure, and a segment of great saphenous vein was excised for histopathologic analysis.Findings were typical of a foreign body reaction.The patient agreed to have a segment of the left gsv, previously treated with 1.4 ml of cyanoacrylate, excised for histopathologic analysis.Under local anaesthesia, a segment of the treated left gsv was surgically excised from the midthigh region.The results of the histopathologic analysis showed that the treated gsv was still occluded, contained polymer remnants, and had characteristics typical of a foreign body reaction.Small areas of neovascularization or recanalization were identified with sma staining; however, the fibrotic or occlusive process clearly dominated in this cyanoacrylate-treated segment.The presence of multinucleated giant cells and granulomatous inflammation in this case is consistent with the prolonged course of a foreign body reaction.Implantation of a foreign material provokes a staged response from surrounding tissues and includes inflammation, wound healing, and foreign body reaction.The response transitions through acute inflammation into a foreign body reaction that continues as long as the implanted material stays in the tissue.

• Brand Name: VENA SEAL CLOSURE SYSTEM
• Type of Device: AGENT, OCCLUDING, VASCULAR, PERMANENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 8874443
• MDR Text Key: 153692360
• Report Number: 9612164-2019-03282
• 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
• Report Date: 08/08/2019

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: 07/31/2019
• Initial Date FDA Received: 08/08/2019
• 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: 65 YR