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Adverse Event Report

W. L. GORE & ASSOCIATES, INC. THIN WALLED FEP RINGED GORE-TEX STRETCH VASC   back to search results
Model Number WLG402
Event Date 04/09/2007
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

In 2007, a thin walled fep ringed gore-tex stretch vascular graft with removable rings (lined) graft was implanted in the axillo-femoral position. The patient presented 14 days postop with a hematoma. Upon reintervention, it was observed the graft ruptured approximately 5 cm from the distal anastomosis (there was no clamping during the procedure). The ruptured portion of the graft and the anastomosis was removed and will be returned for examination. Another graft from w. L. Gore & associates was used to reconstruct the explanted portion of the original graft. It was reported the patient was recovering.

 
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Brand NameTHIN WALLED FEP RINGED GORE-TEX STRETCH VASC
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
W. L. GORE & ASSOCIATES, INC.
1505 north fourth st.
flagstaff AZ 86004
Manufacturer (Section D)
W. L. GORE & ASSOCIATES, INC.
1505 north fourth st.
flagstaff AZ 86004
Manufacturer (Section G)
W. L. GORE & ASSOCIATES, INC.
1505 north fourth st.
flagstaff AZ 86004
Manufacturer Contact
charles silver
1505 north fourth st.
flagstaff , AZ 86004
(928) 864 -4353
Device Event Key838368
MDR Report Key851195
Event Key813891
Report Number2017233-2007-00134
Device Sequence Number1
Product CodeDSY
Report Source Manufacturer
Source Type Foreign,Health Professional,Other
Reporter Occupation Physician
Type of Report Initial
Report Date 05/15/2007
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/15/2007
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date09/24/2011
Device MODEL NumberWLG402
Device Catalogue NumberSRRT06030070L
Device LOT Number04630538
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer04/26/2007
Is The Reporter A Health Professional? Yes
Device Age na
Was The Report Sent To Manufacturer? No
Date Manufacturer Received04/18/2007
Was Device Evaluated By Manufacturer? No
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Type of Device Usage Initial

Database last updated on January 30, 2009

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