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

W.L. GORE & ASSOC., INC. BIFURCATED GORE-TEX STRETCH VASCULAR GRAFT EPTFE VASCULAR PROSTHESIS   back to search results
Model Number WLG302
Event Date 01/10/1998
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

The graft was placed as an aorto-bifemoral bypass in a 65 year old female pt. Twenty-six months postoperatively, the pt developed a pancreatic pseudocyst. Two months later, the pt presented with gastro-intentinal bleeding. Exploratory surgery reportedly revealed an aorto-enteric fistula. A small, 1 cm wide, region around the suture line of the graft to the aorta was found without any tissue coverage. The remainder of the graft outer surface was well incorporated in the surrounding tissues. Directly adjacent to the exposed suture line, an approximately 1 cm by 1 cm large hole was noted in the instestine. Cultures taken were postive for steptococcus viridans. The graft was removed. An axillo-femoral bypass was placed.

 
Search Alerts/Recalls

  new search  |  submit an adverse event report

Brand NameBIFURCATED GORE-TEX STRETCH VASCULAR GRAFT
Type of DeviceEPTFE VASCULAR PROSTHESIS
Baseline Brand NameBIFURCATED GORE-TEX VASCULAR GRAFTS WITH STANDARD AND THIN WALLED LIMBS
Baseline Generic NameEPTFE VASCULAR PROSTHESIS
Baseline Catalogue NumberSBT2002
Baseline Model NumberWLG302
Baseline Device FamilySTRETCH BIFURCATED VASC. GRAFTS
Baseline Device 510(K) NumberK904282
Baseline Device PMA Number
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)NA
Date First Marketed01/16/1991
Manufacturer (Section F)
W.L. GORE & ASSOC., INC.
1505 north fourth st
flagstaff AZ 86004 3000
Manufacturer (Section D)
W.L. GORE & ASSOC., INC.
1505 north fourth st
flagstaff AZ 86004 3000
Manufacturer (Section G)
W.L. GORE & ASSOCIATES,INC
1505 north fourth st.
flagstaff AZ 86003 3000
Manufacturer Contact
monika zaffuto
1505 n. fourth street
flagstaff , AZ 86004
(520) 526 -3030 ext 4262
Device Event Key145380
MDR Report Key149187
Event Key140054
Report Number2017233-1998-00004
Device Sequence Number1
Product CodeDSY
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 02/13/1998
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/13/1998
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL NumberWLG302
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received01/15/1998
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No
Is the Device an Implant? Yes
Is this an Explanted Device?
Type of Device Usage Initial

Database last updated on January 30, 2009

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