MAUDE Adverse Event Report: MEDTRONIC IRELAND RELIANT; CATHETER, PERCUTANEOUS

Catalog Number REL46

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

Patient Problems Ischemia (1942); Renal Failure (2041)

Event Date 07/26/2014

Event Type  Injury  

Event Description

Medtronic received the following information obtained from the journal article entitled; endovascular balloon occlusion is associated with reduced intraoperative mortality of unstable patients with ruptured abdominal aortic aneurysm but fails to improve other outcomes.Maxime raux, md, jean marzelle, md, hicham kobeiter, md, phd, gilles dhonneur, md, eric allaire, md, phd, frédéric cochennec, md, jean-pierre becquemin, md, phd, and pascal desgranges, md, phd.(j vasc surg 2015;61:304-8.) a reliant balloon was used in the patient for the endovascular treatment of ruptured abdominal aortic aneurysm.During the retrospective study the following adverse events were observed: colonic ischemia, renal failure, compartment syndrome.Background: proximal aortic control by endovascular balloon occlusion (ebo) is an alternative to conventional aortic cross-clamping (cac) in hemodynamically unstable patients presenting with a ruptured abdominal aortic aneurysm (raaa).The aim of this study was to evaluate the potential clinical benefit of ebo over cac.Methods: data from 72 patients with raaa treated at our institution from 2001 to 2013 were retrospectively analyzed.All patients were hemodynamically unstable (mean arterial blood pressure at admission <(> <<)>65 mm hg or associated unconsciousness, cardiac arrest, or emergency endotracheal intubation).Clinical end points of hemodynamic restoration, mortality rate, and major postoperative com plications were assessed for cac (group 1) and ebo (group 2).Results: at admission, 72 patients were unstable.Cac was performed in 40 and ebo in 32.Intraoperative mortality was 43% in group 1 vs 19% in group 2 (p [.031).In group 1, the approach for cac (thoracotomy [n [ 23] vs laparotomy [n [ 17]) did not influence intraoperative mortality (43% vs 41%).There was no significant difference in 30-day (75% vs 62%) and in-hospital (77% vs 69%) mortality rates between groups.After ebo, the treatment do pen vs endovascular repair did not influence the intraoperative mortality rate (31% vs 43%; p [.5).Eight surgical complications were secondary to cac (1 vena cava injury, 3 left renal vein injuries, 1 left renal artery injury, 1 pancreatic duodenal vein injury, and 2 splenectomies), but no ebo-related complication was noted (p [.04).Differences in colon ischemia (15% vs 28%) and renal failure (12% vs 9%) were not statistically significant.Abdominal compartment syndrome occurred in four patients in group 2 and in no patients in group 1.Conclusions: compared with cac, ebo is a feasible and valuable strategy and is associated with reduced intraoperative mortality of unstable raaa patients, but not in-hospital mortality, in this retrospective study.

Manufacturer Narrative

(b)(4).

• Brand Name: RELIANT
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway,ie
• Manufacturer (Section G): MEDTRONIC CARDIOVASCULAR; 3576 unocal place; santa rosa CA 95403
• Manufacturer Contact: eric elliott ; 3576 unocal place; santa rosa, CA 95403 ; 7075912586
• MDR Report Key: 4554435
• MDR Text Key: 15900349
• Report Number: 2953200-2015-00387
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K050038
• 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: 02/06/2015

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
• Device Catalogue Number: REL46
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/06/2015
• Initial Date FDA Received: 02/27/2015
• 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: 00075 YR