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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE HYBRID VASCULAR GRAFT-CBAS; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
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W. L. GORE & ASSOCIATES, INC. GORE HYBRID VASCULAR GRAFT-CBAS; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER Back to Search Results
Model Number 0650HYB0710A
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Information (3190)
Event Date 11/02/2017
Event Type  malfunction  
Event Description
Doctor was attempting to do a placement of dialysis graft in the internal jugular vein.A gore hybrid graft was chosen.An attempt was made to deploy the stent and halfway through deployment the mechanism failed, and it was not possible to deploy the rest of the graft.The graft had to be transected near the entry in the jugular vein and the vein ligated since part of the graft with the stent had been deployed.The graft segment was securely in the vein and could not be retrieved.Manufacturer response for vascular graft, hybrid vascular graft (per site reporter).No response as of yet.
 
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Brand Name
GORE HYBRID VASCULAR GRAFT-CBAS
Type of Device
PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
Manufacturer (Section D)
W. L. GORE & ASSOCIATES, INC.
1505 north fourth st.
flagstaff AZ 86004
MDR Report Key7009523
MDR Text Key91344202
Report Number7009523
Device Sequence Number1
Product Code DSY
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 11/06/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator Physician
Device Model Number0650HYB0710A
Device Catalogue Number0650HYB0710A
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/06/2017
Event Location Hospital
Date Report to Manufacturer11/06/2017
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/08/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
NO; NO OTHER THERAPIES
Patient Age70 YR
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