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Adverse Event Report

COOK INC. ZENITH AAA ILIAC LEG GRAFT ENDOVASCULAR GRAFT   back to search results
Catalog Number TFLE-14-88
Device Problem Other (for use when an appropriate device code cannot be identified)
Event Date 07/26/2004
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

Planned during the zenith aaa repair of a abdominal aneurysm was the addition of a main body extension deployed distal to the contralateral leg graft. The use of the extension was for added length in the common iliac artery and to seal the large iliac aneurysm in the vessel without occluding the internal iliac artery. Left internal iliac artery had previously been embolized. Post deployment angiogram noted a distal type iii endoleak, thought to have resulted form a "guttering" effect of the two grafts at the junction of the contralateral iliac leg graft and the main body extension. An iliac leg graft was deployed with the two grafts promoting a seal of the vessel and eliminating of the endoleak. Procedure was concluded noting patency of the left internal iliac, and renal arteries.

 
Manufacturer Narrative

When selecting an extension to be deployed distal to the iliac leg graft, the intended fixation site and the diameter of the existing component to be docked must be considered. Careful consideration of the graft-to-graft and graft-to vessel fixation and seal need to be given in order to avoid endoleaks. Excessive oversizing may result in incomplete expansion, kinks or longitudinal folds in the graft causing endoleaks due to an incomplete seal. An evaluation of the incident found the planning and sizing of the endovascular graft to be the promary factor in the complications encountered. The use of a main body extension in the iliac artery, is an off-label use of the component.

 
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Brand NameZENITH AAA ILIAC LEG GRAFT
Type of DeviceENDOVASCULAR GRAFT
Baseline Brand NameZENITH AAA ILIAC LEG GRAFT
Baseline Generic NameNA
Baseline Catalogue NumberTFLE-14-88
Baseline Device FamilyENDOVASCULAR GRAFT
Baseline Device 510(K) Number
Baseline Device PMA Number
Baseline Shelf Life Information Yes
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)24
Manufacturer (Section F)
COOK INC.
750 daniels way
bloomington IN 47404
Manufacturer (Section D)
COOK INC.
750 daniels way
bloomington IN 47404
Manufacturer Contact
rita harden
750 daniels way
bloomington , IN 47404
(812) 339 -2235
Device Event Key529646
MDR Report Key540338
Event Key513065
Report Number1820334-2004-00482
Device Sequence Number1
Product CodeMIH
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 07/28/2004
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/24/2004
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date05/01/2006
Device Catalogue NumberTFLE-14-88
Device LOT Number1372383
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date07/26/2004
Device Age1 mo
Event Location Hospital
Date Manufacturer Received07/28/2004
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/01/2004
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? Yes
Is this an Explanted Device? No Answer Provided
Type of Device Usage Initial

Database last updated on January 30, 2009

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