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

Device Problem Use of Device Problem (1670)

Patient Problems Stroke/CVA (1770); Rupture (2208)

Event Date 06/26/2019

Event Type  Injury  

Manufacturer Narrative

Event date: date of article publication (i.E.Event date is literature article published date) homemade fenestrated stent-grafts for complete endovascular repair of aortic arch dissections journal of endovascular therapy (2019) vol.26(5) 645¿651 10.1177/1526602819858578.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported in the literature article, homemade fenestrated stent-grafts for complete endovascular repair of aortic arch dissect ions, that 35 patients underwent homemade single- and double-fenestrated stent-graft repair of aortic arch dissections from july 204 to september 2018.Valiant stent-grafts were modified by having a portion of the device unsheathed to expose the area that was to be modified.Fenestrations were marked and fashioned on the stent-graft according to the measurements obtained.A size 11 blade was used to create a proximal large fenestration, where at least 5 mm of fabric was used between the proximal fenestration and the proximal edge of the stent-graft fabric.A cautery device was used to carefully burn the dacron fabric to create the lsa fenestration.A radiopaque nitinol wire from the loop of the snare from a amplatz goose neck snare was used to reinforce the seal around the opening and mark its position, where it was sewn to the edge of the lsa fenestration.The homemade device delivery system was positioned superiorly on entering the arch of the patient.The stent-graft fenestration marker was positioned on the outer curve of the thoracic aorta.The fenestration was oriented towards the lsa by aligning the radiopaque marker with the target vessel.When the marker was misaligned, the stent-graft was pulled back into the descending thoracic aorta, rotated to adjust the position of the fenestration, and reintroduced into the aortic arch.A 7-f sheath was place retrogradely through the left branchial artery access to the ostium of the lsa.The mean blood pressure was then lowered to ~80 mm hg and the stent-graft was partially deployed.A 0.035" guidewire from the branchial access was advanced through the fenestration into the stent-graft lumen.The sheath was then advanced through the fenestration into the stent-graft lumen.The thoracic stent-graft was then fully deployed.A 8- to 10- non-medtronic balloon-expandable covered stent was deployed protruding ~ 5 mm into the aortic stent-graft lumen, with the remaining length in the lsa.The instrastent-graft portion of the covered stent was then flared using a 14- by 20- mm balloon introduced from the branchial access.In two double-fenestrated stent-grafts, lsa catheterization failed and surgical revascularization and stent-graft coverage of the fenestration was required.Three patients with partial coverage of the lcca required placement of a covered stent.After 30 days, one patient with a single-fenestrated stent-graft repair had a stoke without permanent sequelae.Type ii endoleaks required distal extension of the covered stent in the lsa with further covered stent.Two patients with ruptured dissected aortic arch aneurysms died despite successful endovascular exclusion.One late type i endoleak in a patient treated using a single-fenestrated stent-graft was treated by additional proximal fenestrated stent-graft placement, necessitating lsa coverage and surgical revascularization.An additional patient died 4 months after the endovascular procedure of a nonaortic cause.All supra-aortic trunks were patent.Long-term antiplatelet therapy was systematically used in cohort of patients.

• 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: 9502394
• MDR Text Key: 173191346
• Report Number: 2183870-2019-00596
• 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: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/16/2019
• 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: 66 YR