MAUDE Adverse Event Report: COVIDIEN EVERFLEX SELF-EXPANDING PERIPHERAL STENT WITH ENTRUST DELIVERY SYSTEM STANDARD; STENT, SUPERFICIAL FEMORAL ARTERY

Catalog Number UNK-PLY-EVERPSTAN

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

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 01/23/2019

Event Type  Injury  

Manufacturer Narrative

Https://doi.Org/10.1016/j.Avsg.2018.12.055 lift sandwich grafting enables transfemoral abdominal aortic branch incorporation during endovascular aortic repair for chronic type b aortic dissection: date of event: date of article publication.If information is provided in the future, a supplemental report will be issued.

Event Description

This article describes a novel application of the ¿¿lift¿¿ parallel graft technique during staged repair of a post-dissection thoraco abdominal aortic aneurysm.Patient presented a with paravisceral aortic dilatation after initial tevar for a complicated tbad which had been medically managed for 5 years prior but required tevar 3 months prior to the reported procedure below for acute chest pain and right lower extremity malperfusion.At that time, computed tomography angiography (cta) demonstrated a new entry tear just distal to the left subclavian artery, creating a second false lumen.The paravisceral aorta showed triple-barrel configuration with a compressed true lumen adjacent to two false lumens.Patient underwent an emergent left carotid-subclavian bypass, followed by tevar.Lower extremity malperfusion resolved, but postoperative course was complicated by acute kidney injury and shortness of breath.Patient was discharged home on postoperative day 4, with gradual improvement in dyspnea and aggressive management of hypertension and likely chronic kidney disease.At 4 months of follow-up, the patient had rapid progressive aneurysmal degeneration of the distal thoracic and supraceliac aortic segments, despite optimal blood pressure control.A septal fenestration was visible between the celiac and superior mesenteric arteries, leading to persistent false lumen perfusion and dilatation at this aortic segment.Based on these findings, it was decided to cover this septal fenestration to achieve seal and potentially induce favourable remodeling in the distal aorta.Although open surgical and hybrid treatment options were discussed, the patient elected to pursue an initial staged endovascular treatment with extension to the level of the celiac.The use of a sandwich parallel grafting technique was decided on as the best option for distal tevar extension and celiac artery incorporation as it enabled adequate seal across the septal fenestration while limiting the amount of distal coverage.For the celiac incorporation, an up-facing snorkel, creating antegrade perfusion to the branch vessel was the preferred option, rather than a down-facing periscope configuration.The conventional technique for a sandwich snorkel tevar would have required upper extremity access, across the aortic arch or traversing the left carotid artery due to the patient¿s previous left carotid to subclavian bypass.The ¿¿lift¿¿ procedure for transfemoral creation of an up-facing snorkel branch to the celiac artery, sandwiched between thoracic aortic stent grafts was decided on as the best approach.The patient received prophylactic lumbar drain placement.Under general anaesthesia, percutaneous bilateral femoral artery access was performed.Angiography confirmed false lumen perfusion through septal fenestrations near the celiac artery.Intravascular ultrasound confirmed the location of these septal fenestrations.After confirmation of the celiac and superior mesentery artery (sma) locations, the platform for the celiac sandwich was created with a 32- 28 x 178 mm thoracic proximal tapered endograft deployed with the proximal seal zone overlapping into the prior tevar and the distal landing zone just above the celiac origin.The celiac artery was catheterized from the contralateral femoral approach.An 8 x 150 mm covered stent was deployed and reinforced distally with a 10 x 40 mm everflex self-expanding uncovered stent.A 10 x 20 mm balloon secured the stent across the origin of the celiac, and the wire was removed to allow adequate torque.A 6.5-french 90-cm steerable sheath was shaped into a j configuration and advanced up into the thoracic aorta, ¿¿lifting¿¿ the proximal end of the stent into an up-facing snorkel position.Deployment of a 28 x 109 mm endograft completed the sandwich snorkel configuration, terminating distally above the sma.Completion angiography demonstrated antegrade flow to the celiac artery, with preservation of native flow to the sma and diminished retrograde flow into the false lumen.Catheters were withdrawn, and femoral access sites were treated with closure devices.The patient was discharged on postoperative day 3 on dual antiplatelet therapy.On subsequent surveillance cta, the stented aortic segment showed signs of favorable aortic remodeling with false lumen thrombosis and decreased maximum transaortic diameter.The pararenal aorta showed interval growth with the maximum diameter from 49 mm to 57 mm.Despite coverage of the supraceliac aortic septal fenestration, there was persistent false lumen perfusion via the remaining septal fenestrations adjacent to the right renal artery origin and left iliac bifurcation.Therefore, the patient underwent a two-vessel fenestrated endovascular aortic repair (fevar) with incorporation of the sma and right renal artery.The left kidney was atrophic and non-functional.The previous celiac sandwich tevar created an adequate proximal seal zone for the fenestrated stent graft.The patient recovered well from fevar and was discharged on postoperative day 3.At 5-month follow-up post-fevar, the celiac, sma, and right renal branch grafts were patent, with continued favorable remodeling in the entire aorta.

Manufacturer Narrative

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

• Brand Name: EVERFLEX SELF-EXPANDING PERIPHERAL STENT WITH ENTRUST DELIVERY SYSTEM STANDARD
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• 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: 8727454
• MDR Text Key: 149053349
• Report Number: 2183870-2019-00345
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK-PLY-EVERPSTAN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/03/2019
• 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: 59 YR