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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC IRELAND RELIANT CATHETER, PERCUTANEOUS

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MEDTRONIC IRELAND RELIANT CATHETER, PERCUTANEOUS Back to Search Results
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).

 
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Brand NameRELIANT
Type of DeviceCATHETER, 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 Key4554435
MDR Text Key15900349
Report Number2953200-2015-00387
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeFR
PMA/PMN NumberK050038
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Literature,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 02/06/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/27/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberREL46
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received02/06/2015
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 02/27/2015 Patient Sequence Number: 1
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