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); Hematoma (1884); High Blood Pressure/ Hypertension (1908); Pain (1994); Chest Tightness/Pressure (2463); Patient Problem/Medical Problem (2688)

Event Date 02/04/2019

Event Type  Injury  

Manufacturer Narrative

Average age.Male.Date of event: date of publication.Journal article title: outcomes of the chimney technique for endovascular repair of aortic dissection involving the arch branches authors: yuxi zhao, jiaxuan feng, xiaonan yan, guoxian zhu, jian zhou, zhenjiang li, rui feng, and zaiping jing ann vasc surg 2019; 58: 238-247.Doi: https://doi.Org/10.1016/j.Avsg.2018.10.041.Patient death(s) were also included in the results of the journal article, however no causal link suggesting that the medtronic device(s) used in the patient cohort may have caused or contributed to the death(s) was provided.If information is provided in the future, a supplemental report will be issued.

Event Description

This article reports a single centered study of 234 patients with aortic dissection (ad) who were treated with different chimney techniques in different zones of aortic arch.All dissections were complicated and needed intervention other than medicine treatment, such as false lumen expansion, refractory hypertension, persistent chest pain and/or back pain, pleural effusion.164 patients received tevar in acute and 70 patients in chronic phase.156 patients received single chimney (sc).48 patients underwent double-chimney (dc) procedure.There were 30 patients who received triple chimneys (tcs).Therefore, a total of 342 chimney stents were used, with 72.8% being bare-metal stents.Of these bare-metal stents, medtronic¿s complete se bare metal stent was used as chimney graft 8.8% of the time.Eighteen patients received retrograde chimney (rc) tevar , and the remaining 216 patients underwent anterograde chimney (ac) tevar.All cgs were successfully implanted and stayed patent.48 patients entered the intensive care unit (icu) after ctevar.An intraoperative type i endoleak by the last digital subtraction angiography was observed in 75 cases.One patient received reintervention 10 days after the primary ctevar because of progression of hemothorax and existence of type i endoleak.Gutter embolization using a liquid embolic agent and coils was performed.There were 12 patients with hematoma of access artery.One patient suffered from sudden death with suspicious of reoccurrence of ad, and the other one died of heart failure because of coronary atherosclerotic heart disease.There was no stroke in the postoperative period.2 patients died in the third and fifth month after ctevar.Two patients complained about chest tightness and pain and uncontrollable hypertension before sudden death.Three patients suffered from ischemic stroke.Among the 75 patients who had instant type i endoleak during primary ctevar, the endoleak disappeared in 27 patients as revealed by the last cta.In 28.9%, endoleak disappeared in 12 months, and in 52.9%, it disappeared in 24 months.After 2- year follow-up, the endoleak rate remained constant, false lumens in 15 patients were found to be increased.The 15 patients received reintervention by inducing thrombosis of the gutter between aortic and chimney stents, using a liquid embolic agent.All the type i endoleak of the 15 patients were eliminated confirmed by follow-up cta.

• 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: 8892760
• MDR Text Key: 155194030
• Report Number: 9612164-2019-03408
• 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: 08/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/19/2019
• 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: 57 YR