FDA Logo links to FDA home pageCenter for Devices and Radiological Health, U.S. Food and Drug AdministrationHHS Logo links to Department of Health and Human Services website

FDA Home Page | CDRH Home Page | Search | CDRH A-Z Index | Contact CDRH U.S. Food and Drug Administration Center for Devices and Radiological Health [Skip navigation]
horizonal rule
Super Search
510(k) | Registration & Listing | Adverse Events | PMA | Classification | CLIA
CFR Title 21 | Advisory Committees | Assembler | Recalls | Guidance | Standards
 

 

Adverse Event Report

COOK INC ZENITH AAA MAIN BODY GRAFT ENDOVASCULAR GRAFT   back to search results
Catalog Number TFB-30-103
Device Problem Other (for use when an appropriate device code cannot be identified)
Event Date 06/09/2004
Event Type  Injury   Patient Outcome  Required Intervention;
Manufacturer Narrative

Inaccurate placement and/or incomplete sealing of the zenith aaa endovascular graft within the vessel may result in an increased risk of endoleak, migration or inadvertent occlusion of the renal or internal iliac arteries. Parallax is the apparent displacement of an object caused by change in observation position. In attempting to place the first stent body close to the renal arteries as possible, if the operator does not take into account the anterior/posterior angulation of the abdominal aorta, it is possible to deploy the graft too low and not take advantage of the entire infrarenal neck. To minimize parallax, the object of interest must be in the center of the screen with the fluoroscopic beam perpendicular to the object being imaged. As the object of interest gets further from the center of the image, the divergent properties of the x-ray beam tend to distort the image. The assessment of the surrounding factors regarding the renal artery occlusion found operator error to have been the primary cause of the incident.

 
Event Description

Zenith main body graft was introduced via a left femoral artery. During the deployment process, a minor adjustment was made to the table in order to better observe the contralateral side. Before deployment of the main body graft another injection of contrast was not applied ensuring the positioning of the graft to the renal arteries. Main body graft was deployed, not noting at the time that 1-2 millimeters of fabric material was covering the orifice of the left renal artery. Mid-procedure, the impingement of the graft upon the left renal artery was noticed. To resolve the restricted flow through the renal artery, another manufacturer's stent was deployed in the vessel and inflated. After the renal stenting was performed, good blood flow was observed to the left kidney. Clear visualization of the proximal portion of the main body graft showed the proximal gold marker had been pushed downward. After ballooning of the seal and junction sites patency of both renal and internal iliac arteries were noted. No endoleaks were viewed at the conclusion of the procedure.

 
Search Alerts/Recalls

  new search  |  submit an adverse event report

Brand NameZENITH AAA MAIN BODY GRAFT
Type of DeviceENDOVASCULAR GRAFT
Baseline Brand NameZENITH AAA MAIN BODY GRAFT
Baseline Generic NameNA
Baseline Catalogue NumberTFB-30-103
Baseline Device FamilyENDOVASCULAR GRAFT
Baseline Device 510(K) Number
Baseline Device PMA NumberP020018
Baseline Shelf Life Information Yes
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)24
Date First Marketed05/23/2003
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 Key522487
MDR Report Key533221
Event Key506253
Report Number1820334-2004-00404
Device Sequence Number1
Product CodeMIH
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 06/09/2004
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/07/2004
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date04/01/2006
Device Catalogue NumberTFB-30-103
Device LOT Number1358596
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date06/09/2004
Device Age1 mo
Event Location Hospital
Date Manufacturer Received06/09/2004
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/01/2004
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 December 31, 2008

horizonal rule

CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page

Center for Devices and Radiological Health / CDRH