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

Device Problems Leak/Splash (1354); Occlusion Within Device (1423); Inaccurate Delivery (2339)

Patient Problems Aneurysm (1708); Death (1802); Renal Failure (2041); Rupture (2208); Multiple Organ Failure (3261)

Event Date 09/30/2013

Event Type  Death  

Event Description

The following information was obtained from a journal article.Elective treatment of abdominal aortic aneurysm is reasonable in patients >85 years of age.Clemence jouhannet, jean-marc romain de blic, jean-marc alsac, pierre julia, salma el batti, tristan mirault, maximiliano di primio, marc sapoval, emmanuel messas, and jean-noel fabiani.(ann vasc surg 2014; 28: 209¿216).Http://dx.Doi.Org/10.1016/j.Avsg.2013.01.022 background: the numbers of patients >85 years of age referred for abdominal aortic aneurysm (aaa) repair have increased in recent decades.With the population aging, increased screening of aaa, and introduction of less invasive surgical techniques, vascular surgeons will be treating more elderly patients.Few data are available for estimating the risks and benefits of prophylactic repair among those with such an advanced age.The aim of this single-center study was to evaluate the short-term to midterm results after aaa repair in patients >85 years of age.Methods: between 2004 and 2012, data of patients >85 years old who required an elective aaa repair at our institution were collected prospectively.According to the current guidelines, patients underwent endovascular aneurysm repair (evar) each time the aortic anatomy was suitable.Open repair (or) was performed in those patients with hostile proximal neck anatomy and/or severe iliac tortuosity.Type of repair (evar or or) and perioperative and midterm outcomes were analyzed.Primary end points were 30-day mortality and midterm survival.Results: among 1016 patients undergoing elective aaa repair during the study period, 59 (5.8%) were _ 85 years of age (54 men, mean age 87 ± 2 years), with a mean aneurysm diameter of 61.5 ± 20.3 mm.Thirty-three patients (56%) underwent evar and 26 (44%) had an or.Thirty-day mortality was 6.7% (6% with evar and 7.6% with or, p <(><<)>0.05).Mean follow-up was 24.7 ± 18 months.Kaplan-meier analyses for survival were 85.5%, 64.5%, and 50% at 1, 3, and 5 years, respectively.No aneurysm-related death was observed during follow-up.Conclusion: elective repair may be proposed in patients >85 years of age in cases of threatening aaa, showing acceptable perioperative mortality and reasonable midterm survival results.Even if evar did not seem to offer significant benefits in perioperative mortality in our study, it appears reasonable to suggest this less invasive technique as first-line treatment in cases of suitable anatomy in such an advanced-age population.

Manufacturer Narrative

(b)(4).Evaluation, results: inherent risk of procedure (occlusion, renal failure, aneurysm rupture, stent graft misplacement, aneurysm expansion, endoleak, death), (insufficient information; cause is unknown); evaluation, conclusions: known inherent risk of a procedure (occlusion, renal failure, aneurysm rupture, stent graft misplacement, aneurysm expansion, endoleak, death), (insufficient information; cause is unknown).

• Brand Name: ENDURANT
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC CARDIOVASCULAR; 3576 unocal place; santa rosa CA 95403
• Manufacturer (Section G): MEDTRONIC CARDIOVASCULAR; 3576 unocal place; santa rosa CA 95403
• Manufacturer Contact: ludmila voulfson ; 3576 unocal place; santa rosa, CA 95403 ; 7075661229
• MDR Report Key: 3591856
• MDR Text Key: 4187081
• Report Number: 2953200-2014-00116
• 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: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/31/2013

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/31/2013
• Initial Date FDA Received: 01/24/2014
• 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): Death; Required Intervention
• Patient Age: 00086 YR