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

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Aneurysm (1708); Stroke/CVA (1770); Occlusion (1984); Reocclusion (1985); Transient Ischemic Attack (2109); Vascular Dissection (3160)
Date of Event	04/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Average age.Sex: majority gender.Event date: event date is literature article published date endovascular therapy of subclavian artery occlusive disease involving the vertebral artery origin subclavian and vertebral artery intervention (2020) 49(3);205-213 10.1024/0301-1526/a000842.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
This article presents a retrospective study on patients who underwent percutaneous revascularization of the subclavian artery (sa) due to a stenosis or occlusion of the sa or innominate artery (ia).Clinical and procedural characteristics of sa disease and outcomes after endovascular revascularization were retrospectively analysed.A lesion eligible for revascularization was regarded as a significant stenosis (>50 % diameter) or occlusion of the sa or ia, respectively.Antithrombotic treatment included a loading dose of acetylsalicylic acid 300 mg and thienopyridines prior to the procedure.In addition, unfractionated heparin was administered intravenously to achieve an activated clotting time > 250 s.Postinterventional therapy included thienopyridines for at least one month and acetylsalicylic acid indefinitely.In almost all cases, vascular access was obtained via the femoral artery using 6¿8 french (fr) sheaths.Chronic occlusions were approached via a transradial and transfemoral access in the majority of patients.Stent placement was the primary revascularization strategy if technically feasible.Procedural success was defined as residual stenosis 30 %.Follow-up visits including clinical examination and duplex ultrasound were routinely scheduled 3, 6 and 12 months after the procedure and annually thereafter.For assessment of in-stent restenosis (isr), duplex ultrasound and blood pressure difference were used.In patients with suspected isr on the basis of clinical and ultrasound examination, computed tomography or invasive angiography was performed.Primary outcome measure was freedom from isr.Secondary outcome measures included procedural aspects such as procedural success and complication rates.Patients presented with symptoms of vertigo, syncope, arm claudication, paraesthesia, and chest pain.Most frequent symptoms were vertigo and arm claudication.Overall, the endovascular procedure was successful in 96 % with a slightly lower success rate in patients with chronic occlusions.Procedural success did not differ significantly between medial, proximal and distal lesions both in the overall group and when stratified for stenosis and occlusion of the sa.The majority of patients (86.5 %) received a stent implantation after plain balloon angioplasty without significant differences in procedural success compared to pta only.Balloon-expanding stents were predominantly used in proximal lesions whereas more self-expanding stents were implanted in medial and distal lesions.Of the stents used in the procedures, 3% of patients were treated with a protégé everflex stent and 1% with an ever flex entrust.The overall procedural complication rate was low without significant differences between the respective groups.One patient died during index hospital stay due to a sepsis not attributable to the endovascular procedure.One stroke occurred during the intervention of a right-sided proximal subclavian stenosis and was regarded as minor (lasting < 30 days); two patients had a transient ischemic attack (tia).Plaque-shift during medial sa intervention into the va was considered as complication, which, overall, occurred in five patients (2.6 %).Vascular access site complications occurred in seven patients (4 %) with a false aneurysm in six patients (3 %) and one non flow-limiting dissection (0.5 %).

• Brand Name: EVERFLEX SELF-EXPANDING PERIPHERAL STENT WITH ENTRUST DELIVERY SYSTEM STANDARD
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 10147596
• Report Number: 2183870-2020-00171
• Device Sequence Number: 2429630
• Product Code: NIP
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P110023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,literature
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/12/2020

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
• Operator of Device: Health Professional
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2020
• Initial Report FDA Received Date: 06/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR