MAUDE Adverse Event Report: MEDTRONIC IRELAND ENDURANT; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

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

Patient Problems Intimal Dissection (1333); Stroke/CVA (1770); Hematoma (1884); Myocardial Infarction (1969); Occlusion (1984); Pneumonia (2011); Renal Failure (2041); Perforation of Vessels (2135); Heart Failure (2206); Rupture (2208); Claudication (2550); Pseudoaneurysm (2605); Multiple Organ Failure (3261)

Event Date 03/12/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Medtronic received the following information obtained from the journal article entitled: "midterm results with the open chimney technique during endovascular aneurysm repair." eric ducasse, caroline caradu, coline brochier, dominique midy, xavier berard, mathieu poirier, and nicolas ottaviani.Journal of vascular and interventional radiology 2019; 30: 511¿520 https://doi.Org/10.1016/j.Jvir.2018.09.013.An endurant stent graft system was implanted in 22 patients out of a group of 67, for chevar treatment.  the following adverse events were observed: malfunctions: device-to-device and device-to-vessel interaction (with re-intervention) type ia endoleaks type ib endoleak type iii endoleaks adverse events: access site hematomas femoral dissection false-aneurysms lymphoceles buttock claudication iliac limb occlusion iliac rupture pneumonia embolic stroke heart failure myocardial infarction multiple organ failure ruptured aneurysm acute kidney injury death (30-day) abstract purpose: to report the midterm experience with chimney-endovascular aneurysm repair (ch-evar) with the use of open self-expanding stents for branch vessel preservation.Materials and methods: from july 2010 to may 2017, 67 patients underwent open ch-evar because their proximal landing zones were adjacent to, or covered, the renal or mesenteric arteries (zones 7¿9), and they were not suitable for standard or fenestrated endovascular aneurysm repair.The proximal landing zone was relocated below the highest renal artery in 46 cases, the superior mesenteric artery in 17 cases, and the celiac artery in 4 cases, using 84 open chimneys (131 stents).A subgroup analysis was performed between an early (2010¿2014) and a later (2015¿2017) time period.Thirty-two patients were treated during the early period, and 35 were treated during the later period.In the later period, open chimneys were strengthened by a second self-expanding stent.Results: the primary technical success rate was 89.6%; the early mortality rate was 9.0%; and the median follow-up duration was 13 months (range, 1¿76 months).The estimated actuarial survival rate was 85.7% in year 1 and 79.2% in year 2, and the estimated patency rate of open chimneys reached 95.2% at 2 years.Aneurysm sac regression >5 mm and sac stability rates were 39.0% and 57.6%, respectively.Freedom from aneurysm-related reintervention was lower in the later period (log-rank p ¼.04), while type ia endoleaks tended to be twice as likely.Conclusions: midterm results of open ch-evar show high technical success with acceptable midterm patency and lack of endoleak in appropriately selected patients.The advantages over covered stents are lower-profile delivery systems and maintenance of branch vessel patency in early bifurcations and overlying visceral vessels.

• Brand Name: ENDURANT
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; 091708096
• MDR Report Key: 8594994
• MDR Text Key: 144550486
• Report Number: 2953200-2019-00620
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P100021
• 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: 05/09/2019

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: 04/17/2019
• Initial Date FDA Received: 05/09/2019
• 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: 77 YR