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

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

Patient Problems Unspecified Infection (1930); Occlusion (1984); Stenosis (2263); Patient Problem/Medical Problem (2688)

Event Date 10/05/2018

Event Type  Injury  

Manufacturer Narrative

Age or date of birth: average age.Sex: majority gender.Date of event: date available.Online journal article title: outcomes of chimney technique for preservation of the left subclavian artery in type b aortic dissection eur j vasc endovasc surg (2019) 57, 374e381 1078-5884/! 2018 european society for vascular surgery.Published by elsevier b.V.All rights reserved.Https://doi.Org/10.1016/j.Ej vs.2018.09.005.If information is provided in the future, a supplemental report will be issued.

Event Description

This is a single centre retrospective study to report outcomes of the chimney technique for preservation of the left subclavian artery (lsa) in patients with type b aortic dissection (tbad).The procedures were performed in a cardiac catheterisation room under local anaesthesia.All thoracic stent grafts were deployed retrograde via percutaneous femoral artery access employing the pre-closing technique.The morphological features of the aortic lesions were measured with both cta and angiography.Aortic stent graft diameters were generally oversized by 10-15% in tbad with chimney stent.For the lsa chimney stent, a sheath was introduced into the left radial artery (6f) or left brachial artery (7-9 f) according to the size of chimney graft, through which a stiff guide wire was inserted into the ascending thoracic aorta.Aortic arch angiography was performed to confirm the deployment position through the catheter inserted into the femoral artery.After the aortic stent graft was introduced into the aortic arch, the chimney stent was delivered into the lsa through the arterial sheath.Under controlled hypotension and fluoroscopy, the aortic stent graft was firstly deployed, and then the chimney stent was deployed as soon as possible.Angiography was performed to evaluate the positions of the stent graft and the chimney stent.159 chimney stents were deployed in this patient series of which 65%.The brands of stents included maris (invatec) and complete se (medtronic).Access related complications occurred in 2% of patients, including femoral artery stenosis or occlusion which required implantation of a peripheral vascular stent and brachial artery infection requiring antibiotic therapy.The 30-day mortality rate was 2%.The reasons for deaths were aortic rupture in one case, ventricular fibrillation in one case, and major stroke in one case.Three major strokes were recorded in the short term.Two of these patients gradually recovered at discharge, while the other one ultimately died in hospital.Spinal cord ischaemia occurred in 2 cases.Therefore, the major adverse events rate was 4% in the short term.Duration of clinical follow-up is reported as 23+/-16 months for 98% of patients treated.3 deaths were recorded in this timeframe.One was caused by aortic rupture, one by cerebral haemorrhage, and another to rectal cancer.Major stroke occurred in two cases; one had cerebral haemorrhage and eventually died, and the other had cerebral infarction 13 months after the procedure and recovered gradually.One patient received re-intervention because of distal expansion.Chimney stents occlusion is reported in 3% of patients.

• Brand Name: COMPLETE SE ILIAC
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 8518444
• MDR Text Key: 142193286
• Report Number: 9612164-2019-01355
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/16/2019

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: 04/02/2019
• Initial Date FDA Received: 04/16/2019
• 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: 54 YR