MAUDE Adverse Event Report: COVIDIEN PROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM STANDARD; STENT, ILIAC

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

Patient Problems Stroke/CVA (1770); Hematoma (1884); Myocardial Infarction (1969); Perforation (2001); Renal Failure (2041); Seroma (2069); Hernia (2240); Stenosis (2263); Obstruction/Occlusion (2422); Post Operative Wound Infection (2446); Thrombosis/Thrombus (4440)

Event Date 02/09/2022

Event Type  Injury  

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a journal article titled 'hybrid vs.Open surgical reconstruction for iliofemoral occlusive disease: a prospective randomised trial '.The articles reported on a prospective single centre randomised trial performed to compare the short and midterm safety and efficacy of hr and or procedures for patients with co-existing iliac and cfa occlusive disease.From 2015 to 2017, eligible patients presenting with combined iliac and cfa occlusive disease were randomised to either hr or or.Hr group patients underwent recanalisation and stenting of iliac arteries combined with cfa endarterectomy and patch angioplasty.Nosis 70% (n ¼ 56), and no consent (n ¼ 89).Ultimately, 202 patients were included with 102 patients randomised to hr group and 100 to or group.Atherosclerosis was the cause of occlusive disease in all cases.The or group underwent aortofemoral bypass with simultaneous cfa endarterectomy.Short (30 day) and midterm (36 month) outcomes including morbidity, mortality, and patency rates were compared between groups.The primary outcomes included hospital length of stay; 30 day mortality/major adverse cardiac events (maces); 30 day morbidity/complication rate (including wound complications); 30 day graft/stent patency rates (evaluated for the more severely affected limb); 30 day graft infection rates.The secondary outcomes included 36 month graft infection, mortality, morbidity, graft/stent patency, limb salvage and amputation free survival (afs) rates.Before surgical reconstruction all the patients of both groups were investigated with duplex ultrasonography, ankle brachial pressure index (abi) measurements, and multidetector computed tomographic angiography (mdct).In patients allocated to the hr group, local or spinal anaesthesia was used.All or cases were performed under general anaesthesia.The hr operations were performed in an angiography suite.Initially, for the hr group, an attempt was made to obtain retrograde access to the aorta via femoral access and secure aortic inflow before making the arteriotomy.Ipsilateral/ contralateral femoral or brachial approaches were used depending on the clinical situation.After recanalisation and balloon angioplasty of the iliac artery, the procedure was completed with endarterectomy of the cfa.Once cfe was performed, the proximal and distal ends were secured with tacking sutures and the femoral artery was closed with standard bovine pericardial patch angioplasty.Subsequent access to the iliac arteries was performed through a central patch puncture with an 18 gauge needle and a 7f sheath was then placed over the wire.Cfe was performed prior to iliac stenting because of easier access to the true lumen in a difficult cfa lesion.Primary stenting of common iliac artery lesions (with a severely calcified segment) was carried out with balloon expandable stents (non-medtronic).Diameters ranged from 8 to 10 mm.Primary stenting of external iliac lesions and some long occlusions was performed with self-expanding non-medtronic or protege everflex nitinol stents after iliac recanalisation.The diameters varied between 7 and 9 mm.For long lesions of the external iliac artery, the practice was to extend the treatment zone with percutaneous transluminal angioplasty (pta) or stenting down to the superior border of the inguinal ligament.Neither high pressure nor cutting balloons were used in the study.In the or group, aortofemoral or aortobifemoral bypasses were performed through a retroperitoneal approach with a bifurcated or straight dacron graft sutured end to side proximally and distally.Concomitant cfe was performed in all patients who underwent or.For both groups, profundaplasty was performed when the profunda femoris artery had > 50% stenosis on preoperative computed tomography scan, or at the time of operation if the orifice was not accessible with a 3 mm dilator.After hrs, aspirin (100 mg per day) and clopidogrel (75 mg per day) were prescribed for six months.After six months, clopidogrel was stopped and long term aspirin (100 mg per day) was recommended.After or, aspirin monotherapy (100 mg per day) was prescribed for life.The post-operative follow up visits (at one, 12, 24, and 36 months post-procedure) consisted of physical examination, abi measurement, and duplex scan of the bypass graft or iliac stent and cfe site.If there was a suspicion of stent, bypass, or cfe restenosis 70% or occlusion, mdct was performed for further evaluation.The average hospital length of stay was shorter in hr group.There were no deaths, and no maces in either group within 30 days post-operatively.Complications in the 30 day post-operative period included stent/graft thrombosis, bleeding/haematoma, groin seroma, wound infections, acute renal failure, ventral hernia.Overall, 30 day complications occurred in 8.8% of hr and 21.0% of or cases.In the hr group, there was one (1%) case of iliac artery perforation during stent pre-dilation which was treated successfully by stent graft implantation.Thirty day stent/graft thrombosis occurred in three (3%) hr group cases and six (6%) or patients.Surgical thrombectomy was successful in all patients.Post-operative bleeding requiring surgical intervention occurred in one case (1%) in both groups (blood transfusion was not required).Groin seromas occurred in four (4%) hr and seven (7%) or patients, all of whom were obese (body mass index [bmi] > 30).Conservative treatment was performed in all cases (bandaging and local injection of lipiodol).Superficial groin wound infections were diagnosed in one (1%) hr and one (1%) or case (p ¼.70).Both cases were grade 2 according to the szilagyi classification and group 2 according to the samson classification.Both patients were obese (bmi > 30) and required wound debridement with excision of necrotic wound edges.Vascular graft infection was not diagnosed.Acute renal failure, requiring renal replacement therapy developed in one (1%) or case (p ¼.50).Five (5%) or cases developed ventral hernia within 30 days (all of these patients were obese with bmi > 30).No other peri-operative complications developed in either group.No vascular graft infections were diagnosed during three year follow up.Midterm (36 month) postoperative complications and results included myocardial infarction, stroke, death, stenosis, thrombosis, major amputation.At 36 month follow up, three (3%) hr patients died (at eight, 12 and 26 months) compared with seven (7%) or patients (at 9, 11, 12, 15, 18, 21, and 33 months).None of these patients had undergone re-interventions.The causes of death were not associated with the iliac occlusive disease and were reported as myocardial infarction , stroke and oncology related malignancy.During 36 month follow up stent/graft stenosis 70% and cfa/distal anastomosis stenosis 70% were detected in 11 (11%) hr group patients and nine (9%) or patients (p ¼.43).Endovascular re-interventions were performed in four cases in the hr group.Hybrid operations (aortofemoral bypass stenting with reconstruction of the distal anastomosis) were carried out in two or cases.The cumulative primary patency rates at 12 and 36 months were 93% and 91% in the hr group and 93% and 89% in the or group, respectively.Secondary patency rates at 12 and 36 months were 99% and 98% in hr group and 99% and 97% in or group, respectively.During the three year follow up, major amputations (ipsilateral) were performed in two patients of the hr group (above knee amputation) and three patients in the or group (one below and two above knee amputations).The limb salvage rates at 12 and 36 months were 99% and 98% in the hr group and 99% and 97% in the or group, respectively.

• Brand Name: PROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM STANDARD
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 15456363
• MDR Text Key: 300255430
• Report Number: 2183870-2022-00311
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: P110023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2022
• 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: 08/30/2022
• 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
• Patient Sex: Male