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Adverse Event Report

COOK, INC. ZENITH AAA ILIAC LEG GRAFT ENDOVASCULAR GRAFT   back to search results
Catalog Number TFLE-24-54
Device Problem Other (for use when an appropriate device code cannot be identified)
Event Date 03/10/2004
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

Endovascular graft was placed with contralateral leg graft noted to land short of the desired landing zone. Physician elected to place a main body extension of the appropriate diameter distal to the leg graft in order to extend the graft while providing more securement and radial force at the landing zone, since the pt's aneurysm extended into the left common iliac artery. Main body extension was placed successfully. Final angiogram viewed patent hypogastrics and no indication of endoleak presence.

 
Manufacturer Narrative

Careful evaluation of the pt's anatomy from the distal thoracic aorta to the superficial femoral arteries should be made when determining accurate sizing of the zenith aaa endovascular graft. Incorrect sizing of the length of the contralateral iliac leg graft component was determined to be the cause for the placement of an additional endovascular graft. No device malfunction was noted during this procedure.

 
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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-24-54
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 Key508441
MDR Report Key519377
Event Key492852
Report Number1820334-2004-00213
Device Sequence Number1
Product CodeMIH
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 03/19/2004
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/06/2004
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date01/01/2006
Device Catalogue NumberTFLE-24-54
Device LOT Number1324129
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date03/19/2004
Device Age2 mo
Event Location Hospital
Date Manufacturer Received03/19/2004
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/01/2004
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 February 28, 2009

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