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Adverse Event Report

COOK INC. ZENITH AAA ILIAC LEG GRAFT ENDOVASCULAR GRAFT   back to search results
Catalog Number TFLE-14-54
Device Problem Other (for use when an appropriate device code cannot be identified)
Event Date 01/20/2004
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

The endovascular graft components were deployed and placed according to the instruction manual. During the post angiogram, a distal type 1 endoleak was reviewed at the distal end of the ipsilateral leg graft. After several attempts to mold the distal end of the ipsilateral leg graft, another iliac leg graft was placed within the existing iliac leg and extended approximately five millimeters distal of the graft, very close to the hypogastric artery. The second leg graft was ballooned and retrograde angiogram noted that the endoleak had been resolved. Final angiogram was performed viewing only a late filling type ii endoleak from a lumbar artery. No further intervention was deemed necessary.

 
Manufacturer Narrative

The iliac leg graft was not available to be returned for the company's examination and evaluation of this reported event. Vessels that are significantly calcified, occlusive, tortuous, or thrombus-lined may preclude placement of the endovascular graft and/or may increase the risk of embolization or endoleak. Common iliac artery diameters greater than twenty millimeters at the expected graft/vessel distal fixation site may be prone to endoleak or continued expansion and are not indicated for placement of the endovascular graft. Early endoleaks are thought to result from a variety of causes including improper device sizing, inappropriate pt selection, malpositioning of the endovascular graft, inadequate radial force, lack of immediate thrombosis of collateral vessels, and inappropriately high graft porosity. Inaccurate placement and/or incomplete sealing of the zenith endovascular graft within the vessel may result in an increased risk of endoleak or migration. Good angiography and ct imaging are paramount for accurate planning. Careful evaluation of the pt's anatomy from the distal thoracic to the superficial femoral arteries should be made. Endoleaks observed at the proximal or distal sealing sites may result from inadequate apposition of the graft to vessel wall at the fixation site and may be resolved by a repeat inflation of the molding balloon at the site. If necessary additional extensions or other necessary interventional measures may need to be considered.

 
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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-14-54
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 Key500433
MDR Report Key511464
Event Key485225
Report Number1820334-2004-00071
Device Sequence Number1
Product CodeMIH
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 01/23/2004
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/16/2004
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date11/01/2005
Device Catalogue NumberTFLE-14-54
Device LOT Number1311101
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date01/23/2004
Device Age1 mo
Event Location Hospital
Date Manufacturer Received01/23/2004
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/01/2003
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 February 28, 2009

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