MAUDE Adverse Event Report: COVIDEN GOOSENECK SNARE; CATHETER, PERCUTANEOUS

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

Patient Problems Rupture (2208); Cardiac Tamponade (2226); Thromboembolism (2654)

Event Date 09/07/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Event date:(b)(6) 2018 published date of article an unusual cause of acute heart failure: a case report of iliocaval venous stent migration journal of investigative medicine high impact case reports (2018) vol 6; 1-3 10.1177/2324709618799118.If information is provided in the future, a supplemental report will be issued.

Event Description

Stent migration is an uncommon complication of endovascular stenting procedures.It could cause serious cardiovascular complications.In this article, we describe an interesting case of acute heart failure as a result of stent embolization from the left common iliac vein into the right ventricle and how it was identified and managed.A patient underwent peripheral endovascular intention for may-thurner sysdrome (stenosis) with placement of a self-expanding nitinol protégé stent to the left iliac vein.6 months post procedure the patient was diagnosed with acute heart failure and pneumonia and was administered diuretics and antibiotics.Other symptoms included dyspnea and lower extremity edema.A transoesophageal echocardiogram revealed the stent straddling the tricuspid valve from the right atrium with the other end lodged in the trabeculation of the right ventricle with severe tricuspid regurgitation.A percutaneous endovascular approach with a 35- mm medtronic-covidien amplatzer gooseneck snare was initially attempted to retrieve the migrated stent.However, the snared proximal segment fractured, leaving behind 2 stent fragments.The patient was subsequently referred for surgical extraction via median sternotomy with use of cardiopulmonary bypass.During the operative procedure it was found the majority of the primary chords to the anterior and posterior leaflets ruptured.After successful stent extraction she underwent valve replacement with a non-mdt device.Her postoperative course was complicated by hemopericardium secondary to anticoagulation resulting in cardiac tamponade that was drained percutaneously, and small thromboembolic cerebellar stroke from atrial fibrillation.She was discharged to an inpatient rehabilitation facility and did well on 8-month follow-up.

• Brand Name: GOOSENECK SNARE
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COVIDEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 8109768
• MDR Text Key: 128561742
• Report Number: 2183870-2018-00538
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K970668
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2018
• 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: 10/31/2018
• 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: 61 YR