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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 REL46J
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Ischemia (1942); Perforation of Vessels (2135)
Event Date 03/26/2015
Event Type  Death  
Event Description

A reliant balloon was utilized in another manufacturer¿s stent graft endovascular procedure for treatment of a patient with an abdominal aortic aneurysm. Aneurysm morphology was not reported. The aortic neck was described as long and angulated with a diameter of 23 mm. A type ia endoleak was confirmed (from another manufacturer¿s 26 mm diameter device). It was reported that the stent graft got wrinkled post implant. It was reported that when touch-up was carried out with a reliant balloon at the proximal end of the device (from another manufacturer), the aorta ruptured where the flared part of the device was. The physician stated there was over inflation. The physician removed all the stent grafts and performed aortic reconstruction with a synthetic graft for repair of the aortic rupture. The treatment was completed successfully. It was also noted that one day post implant the patient had an onset of acidosis. Since bowel ischemia was suspected, laparotomy was carried out for examination and duodenum necrosis was confirmed. The physician determined that it was impossible to have surgical repair and closed the surgical incision. The next day the patient passed away due to bowel ischemia. The physician indicated the cause of aortic rupture was possibility due to excessive dilatation during touch-up. As for the cause of bowel ischemia, the physician confirmed patency of 3 abdominal branched vessels with post-operative ct image. The physician indicated the possibility that mural thrombus flowed and occluded a peripheral blood vessel that led to an intestinal canal during device implant or during placement of the synthetic graft. Additionally, pre-operatively the vessels did not pose any risks. The physician stated that there was a possibility that the peripheral blood vessel would initially have anomalies and blood flow volume would be decreased by the damaged aorta during the procedure, which may have caused an onset of non-obstructive bowel ischemia. Biopsy was not performed and further information on the cause of bowel ischemia was unprocurable. The physician is not considering this event as device related.

 
Manufacturer Narrative

(b)(4).

 
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Brand NameRELIANT
Type of DeviceCATHETER, PERCUTANEOUS
Manufacturer (Section D)
MEDTRONIC IRELAND
parkmore business park west
galway
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 Key4740339
MDR Text Key5703197
Report Number2953200-2015-00809
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
PMA/PMN NumberK050038
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/13/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/30/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberREL46J
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received05/13/2015
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: 04/30/2015 Patient Sequence Number: 1
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