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

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

Patient Problems Stroke/CVA (1770); Ischemia (1942); Rupture (2208); Vascular Dissection (3160); Thrombosis/Thrombus (4440); Restenosis (4576)

Event Date 06/03/2022

Event Type  Injury  

Event Description

Medtronic received a journal article titled 'management and outcomes of non-a non-b aortic dissection'.From january 2016 to may 2020, 215 consecutive patients with acute or subacute non-a non-b aortic dissection were enrolled in a study.The primary endpoints were all cause death.Secondary endpoints included follow up adverse aortic event (ae), a composite of the outcomes of dissection related death, rupture, retrograde type a aortic dissection, stent graft induced new entry tear, secondary endoleak, and follow up re-intervention.Patients were divided into three groups according to the treatment they received: the best medical treatment (bmt) group (n = 46), the endovascular-based treatment (ebt) group (n = 127), and the total arch replacement with frozen elephant trunk (tar þ fet) group (n= 42).Technical success for endovascular treatment was defined as successful introduction and deployment of the device without re-intervention, death within 24 hours, type i or type iii endoleak as evidenced by intra-operative completion angiography, or graft obstruction.The primary endpoint was all cause death.Secondary endpoints included follow up aortic adverse events (aes), a composite of the outcomes of dissection related death, rupture, retrograde type a aortic dissection, stent graft induced new entry tear (sine), secondary endoleak, and follow up re-intervention.Early outcomes were defined as death and morbidity during hospitalisation or within 30 days from intervention.Follow up re-intervention was described as any unplanned re-endovascular treatment or open surgery > 30 days after intervention (ebt or tar þ fet group) or any intervention after index discharge (bmt group) due to complications of index treatment, device failure, or progression of the dissection process.Ebt involved thoracic endovascular aortic repair (tevar) with (tevar zone 0/1/2) or without (tevar zone 2) supra-arch bypass or chimney stent implantation.The diameters of the aortic stent grafts were generally oversized by 10% e 15% for chimney stent implantation and 5% e 10% for other implantations.Chimney stents used included complete se and 5 other non-medtronic brands.Outcomes reported in the endovascular based treatment group reported were stroke, mesenteric ischaemia, retrograde type a dissection, aortic rupture, re-intervention, re-occlusion and thrombus.

Manufacturer Narrative

Title: management and outcomes of non-a non-b aortic dissection ref: doi.Org/10.1016/j.Ejvs.2022.05.037 authors: jitao liu, fan yang, lyufan chen, enmin xie, sheng su, yuan liu, qingshan geng, ruixin fan, jie li, jianfang luo 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: 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: 16634306
• MDR Text Key: 312194796
• Report Number: 9612164-2023-01315
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P090006
• 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: 03/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2023
• 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: 02/28/2023
• 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