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

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

Patient Problems Hemorrhage/Bleeding (1888); Myocardial Infarction (1969); Necrosis (1971); Pain (1994); Ulcer (2274); Obstruction/Occlusion (2422); Pseudoaneurysm (2605); Ischemia Stroke (4418); Embolism/Embolus (4438); Thrombosis/Thrombus (4440); Restenosis (4576)

Event Date 08/22/2022

Event Type  Injury  

Event Description

Medtronic received a journal article reporting ' midterm outcomes of endovascular therapy for tasc ii d femoropopliteal lesions with critical limb ischemia: a retrospective analysis¿.From september 2016 to october 2020, 57 limbs of 54 patients with critical limb ischemia (cli) due to trans-atlantic inter-society (tasc) ii d femoropopliteal lesions who underwent endovascular therapy (evt) were retrospectively analysed in a single-centre, observational study.Procedures were performed under local or general anaesthesia by the same group of vascular surgeons.Access to the target lesion was determined using a 6f 45cm non-medtronic sheath, crossing over the aortic bifurcation, or using a 6f 16cm non-medtronic sheath via an antegrade approach.After sheath placement, unfractionated 100 iu/kg heparin was administered by injection.A 150cm 0.035-inch non-medtronic hydrophilic guidewire crossed through the culpritlesions.The target vessel was first opened in the true lumen and a subintimal technique was used if this failed.To reduce damage, a balloon with a diameter 1 mm narrower than the target vessel was chosen.Predilation with small balloon catheter was performed for = 2 min to limit the risk of dissection.Using a stent sizing selected to a 1:1 ratio to the normal artery segment diameter and extending at least 10 mm past the lesion proximally and distally.Adjacent stents were overlapped by 1 cm maximum.A radiopaque ruler was used to measure the length of the stented segment.Four types of nitinol self-expanding stents were implanted: protege everflex or 3 other non-medtronic stents.The routinely postdilated balloon after stenting was performed within the stented segment.In case of a percutaneous approach, groin closure was accomplished by manual compression or by using a 2mm non-medtronic vascular closure device.Aspirin (100 mg/d) and clopidogrel (75 mg/d) were administered in the absence of contraindications at least 3 days before operation, after which only aspirin (100 mg/day) was continued.The final technical success (residual stenosis <(><<)> 30% and positive blood flow) rate was 98.2% (56/57).In 1 patient, the guidewire did not cross the target lesion and surgical revascularization with bypass was required.This limb was excluded from analysis.During the perioperative period, 6 limbs developed procedure related complications: 2 cases of myocardial infarction with 1 procedure-related death; 1 case of ischemic stroke, 1 case of in-stent acute thrombosis and 1 case of distal embolization, both of which were treated successfully with thrombolytic therapy; 1 case of pseudoaneurysm that required open surgery; and 1 case of local bleeding at the site of vascular access, requiring blood transfusion without surgery.There were also 23 cases of pain at rest, 18 cases of ulcer, and 15 cases of gangrene.Follow-up visits of outpatient administration were commonly scheduled at 1, 3, 6, and 12 months after the procedure.Thereafter, they were evaluated at 6-month intervals.Follow-up included an interview, health education with correction of cardiovascular risk factors, abi, ultrasound imaging, and clinical examination.No clinical worsening was found during follow-up.Of the 56 limbs in this group, 49 (87.5%) required a secondary stenting procedure because of an inadequate percutaneous transluminal angioplasty (pta) result.The perioperative complication rate was 10.7% (6/56).The restenosis or occlusion rate was 44.6% (25/56).The estimated rates of freedom from target lesion revascularization (tlr) at 1 year, 2 years, and 3 years were 86.8%, 67.0%, and 62.5%, respectively.The ulcer healing rate was 93.8%.The limb salvage rates were 76.4%, 74.4%, and 70.9% at 1, 2, and 3 years after treatment, respectively.

Manufacturer Narrative

Peng liu, li-hua zheng, xin-qi he, yan yang, li-ke zhang, lei zhang, and feng zhang, shijiazhuang, hebei ¿midterm outcomes of endovascular therapy for tasc ii d femoropopliteal lesions with critical limb ischemia: a retrospective analysis.¿ ann vasc surg 2023; 88: 182¿190.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.

• Brand Name: PROTEGE EVERFLEX SELF-EXPANDING STENT 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: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 17267255
• MDR Text Key: 318495437
• Report Number: 2183870-2023-00249
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: 110023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2023
• 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: 06/08/2023
• 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: 68 YR
• Patient Sex: Male