MAUDE Adverse Event Report: MEDTRONIC IRELAND COMPLETE SE ILIAC; STENT, ILIAC

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

Patient Problem Restenosis (4576)

Event Date 11/22/2022

Event Type  Injury  

Manufacturer Narrative

Title: efficacy of a drug-eluting stent versus bare metal stents for symptomatic femoropopliteal peripheral artery disease: primary results of the eminent randomized trial authors: yann gouëffic , giovanni torsello, thomas zeller, giovanni esposito , frank vermassen, klaus armin hausegger, gunnar tepe, marcus thieme, michael gschwandtner, andrea kahlberg , marc schindewolf, marc sapoval, juan diaz-cartelle, konstantinos stavroulakis journal: circulation issue: 2022;146:1564¿1576 ref:10.1161/circulationaha.122.059606 a2: average age a3: majority sex 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 'efficacy of a drug-eluting stent versus bare metal stents for symptomatic femoropopliteal peripheral artery disease: primary results of the eminent randomized trial'.It reports on a prospective, randomized, controlled, multicenter european study with blinded participants and outcome assessment.Pa tients with symptomatic peripheral artery disease of the native superficial femoral artery or proximal popliteal artery with stenosis =70%, vessel diameter of 4 to 6 mm, and total lesion length of 30 to 210 mm were randomly assigned 2:1 to treatment with des or bms.A total of 775 patients were randomly assigned to treatment with des (n=508) or commercially available bmss (n=267).The interventional device was a non-medtronic des.Control devices were bmss, specifically self-expanding bare nitinol stents commercially available in europe that were indicated for improving luminal diameter for the treatment of de novo or restenotic symptomatic lesions in native vascular disease of above-the-knee femoropopliteal arteries.Permitted stents were complete se vascular stent (12/294), everflex peripheral self-expanding stent (46/294) and other non-medtronic stents.12-month efficacy and safety data reported 165/222 patients with primary patency, 0 cases of target major limb amputation and 28/263 patients with tlr in the bms group.

• Brand Name: COMPLETE SE ILIAC
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 17236917
• MDR Text Key: 318182398
• Report Number: 9612164-2023-02912
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P110040
• 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: 06/30/2023

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/14/2023
• Initial Date FDA Received: 06/30/2023
• 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: 69 YR
• Patient Sex: Male