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U.S. Department of Health and Human Services

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

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MEDTRONIC IRELAND ENDURANT II EXTENSION CUFF; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT Back to Search Results
Model Number ETCF3636C49E
Device Problems Separation Failure (2547); Folded (2630)
Patient Problem Injury (2348)
Event Date 05/27/2015
Event Type  malfunction  
Event Description
An endurant ii stent graft system was implanted for the endovascular treatment of a 6.1 cm diameter abdominal aortic aneurysm.It was reported that during the index procedure, after deployment of aortic cuff for treatment of a persistent type ii endoleak and placement of endovascular anchors, the physician noticed the aortic cuff looked infolded and the supra renal stents did not appear to deploy correctly.This was confirmed with intravascular ultrasound.There were no endoleaks as a result of the cuff infolding at the end of the procedure.The physician stated the event was related to the device.  no clinical sequelae were reported and the patient is being monitored.Film review analysis: review of 2 short videos during an angio intervention revealed that a talent aaa was seen positioned with an endurant aortic cuff placed approximately 1cm above the bifurcate aortic body.Several anchors were also seen placed within the aortic body and bifurcate.Ballooning was performed within the aortic body.After deflation, the ballooned stent graft did not appear to be fully apposed within the bifurcate aortic body.No contrast injections were seen in the video¿s therefore the patency of the graft lumens or any possible endoleak could not be assessed.A single still angio image without contrast showed the suprarenal stents from the endurant cuff; however, the reported suprarenal entanglement could not be confirmed (or ruled out) from this single image.The cause of the reported stent graft infolding and suprarenal stent entanglement could not be determined from the limited films provided.Images showing the deployment of the aortic cuff and removal of the cuff delivery system were not available for review.The non¿contrast images also made the assessment of the events and determination of the possible cause difficult.
 
Manufacturer Narrative
(b)(4).
 
Manufacturer Narrative
(b)(4).
 
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Brand Name
ENDURANT II EXTENSION CUFF
Type of Device
SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
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 Key4856866
MDR Text Key16462242
Report Number9612164-2015-01045
Device Sequence Number1
Product Code MIH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P100021
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative,company representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 02/04/2016
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
Device Expiration Date07/21/2016
Device Model NumberETCF3636C49E
Device Catalogue NumberETCF3636C49E
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 05/27/2015
Initial Date FDA Received06/19/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received02/04/2016
Date Device Manufactured07/22/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age00081 YR
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