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

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

Patient Problem Stroke/CVA (1770)

Event Date 03/25/2019

Event Type  Injury  

Manufacturer Narrative

Date of publication journal article title: double homemade fenestrated stent graft for total endovascular aortic arch repair copyright _ 2019 by the society for vascular surgery.Published by elsevier inc.Https://doi.Org/10.1016/j.Jvs.2018.11.054.If information is provided in the future, a supplemental report will be issued.

Event Description

Objective: the aim of this retrospective analysis was to evaluate the outcomes of physician-modified double fenestrated stent grafts for total endovascular aortic arch repair: one proximal large fenestration for the brachiocephalic trunk and the left common carotid artery and one distal fenestration for the left subclavian artery (lsa).Methods: from january 2017 through february 2018, 17 patients (88.2% elective) underwent thoracic endovascular aortic repair (tevar) with double homemade fenestrated stent graft for total endovascular aortic arch repair to maintain supraaortic trunk patency.Indications were degenerative aortic arch aneurysm (n = 7), dissecting aortic arch aneurysms subsequent to surgical treatment of acute type a dissections (n = 6), chronic complicated type b aortic dissection (n = 3), and acute complicated type b aortic dissection (n = 1).Routine postoperative follow-up imaging with computed tomography angiography was performed to assess tevar and supra-aortic trunks patency and endoleak.Results: the median time for stent graft modification was 19 minutes (range, 16-20 minutes).Endovascular exclusion of the aortic arch was achieved in all the cases.One lsa catheterization failed and lsa revascularization was performed by carotid axillary bypass and coverage of the lsa fenestration by additional stent graft placement.Additional planned endovascular procedures were required in three patients: closure of supra-aortic trunks re-entry tears in two cases of dissecting aortic arch aneurysms and one transcatheter aortic valve replacement for severe native aortic valve regurgitation.One stroke, with no long-term deficit, was observed.No patients died.All left supra-aortic trunks are patent.No type i endoleak was observed.We only observed one patient with a type ii endoleak.During a mean follow up of 7 6 2 months, there were no conversions to open surgical repair, aortic rupture, paraplegia, or retrograde dissection.Conclusions: double homemade fenestrated tevar is both feasible and effective for maintaining the patency of the supra-aortic trunks and allows total endovascular aortic arch repair.Durability concerns will need to be assessed in additional studies with long-term follow-up.

• Brand Name: GOOSENECK SNARE
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 9266807
• MDR Text Key: 165628141
• Report Number: 2183870-2019-00531
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K972511
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/10/2019
• 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 Age: 70 YR