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); Occlusion (1984); Injury (2348); Aortic Dissection (2491); Vascular Dissection (3160)

Event Date 12/02/2019

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

A journal article was submitted that documented a study where off-shelf devices were used for treatment of thoracic aortic diseases.Retrospective analysis was conducted of 474 consecutive patients treated with either fenestration tevar (f-tevar) or chimney tevar (ch-tevar).The complete se stents were only implanted in patients in the f-tevar group.The primary endpoints at 30 days and during follow up were overall mortality, aorta-related mortality, and major complications.The secondary endpoints were endoleak and reintervention.It was reported that 4 patients died within 30 days of procedures.One patient with tad suffered a retrograde dissection which resulted in death on the third day.Of the three deaths among the 364 ch-tevar patients, one was due to cerebral infarction 3 days post procedure, another to retrograde dissection at 2 days and third to myocardial infaction 4 days post tevar.Perioperative cerebral ischemia occurred in nine patients: 1 f-tevar patient had a tia with full recovery in follow up vs 7tias in ch-tevar group (all treated and discharged), in addition to the fatal stroke noted above.Two f-tevar patients died of retrograde dissection at 8 and 16 months in addition to the one in hospital.In the ch-tevar group, 7 patients died at follow up in addition to the fatal retrograde dissection in hospital.Of these 7 late deaths, 2 were sudden deaths after complaining about chest tightness and uncontrollable hypertension that was believed to be related to tad.One patient died of acute cerebral infarction, 3 patients died of retrograde dissection af ter open surgery, and one patient died of pulmonary infection subsequent to paraplegia.During entire follow up period, 22 patients suffered cerebral ischemia (4 in f-tevar group and 18 in the ch-tevar group).Stent migration and retrograde dissection occurred in 11 and 13 of all patients respectively, without significant differences between treatment approaches.36 patients underwent reintervention for proximal type i endoleak.One hundred of the 593 branch stents occluded.Of the 62 patients with branch occlusion, 28 were asymptomatic, and no reintervention performed.As of the bare metal stents used in f-tevar, the majority (26/27) were patent.

• Brand Name: COMPLETE SE ILIAC
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; IE
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; IE
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; IE ; 091708734
• MDR Report Key: 9665019
• MDR Text Key: 177775258
• Report Number: 9612164-2020-00554
• 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: 02/04/2020

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: 01/20/2020
• Initial Date FDA Received: 02/04/2020
• 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): Hospitalization; Required Intervention
• Patient Age: 64 YR