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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE-TEX VASCULAR GRAF; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
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W. L. GORE & ASSOCIATES, INC. GORE-TEX VASCULAR GRAF; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER Back to Search Results
Catalog Number RRT08070080L
Device Problem Material Puncture/Hole (1504)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/08/2020
Event Type  malfunction  
Manufacturer Narrative
 
Event Description
The following was reported to gore: on an unknown date, a patient underwent treatment for an unknown etiology where a gore-tex® vascular graft was implanted.After the procedure, imaging identified an alleged hole in the graft.Further information was requested but not made available as of today.
 
Manufacturer Narrative
W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
 
Event Description
The following was reported to gore: on an unknown date, a patient underwent treatment for an unknown etiology where a gore-tex® vascular graft was implanted.After the procedure, imaging identified an alleged hole in the graft.Further information was requested but will not be made available.
 
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Brand Name
GORE-TEX VASCULAR GRAF
Type of Device
PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
Manufacturer (Section D)
W. L. GORE & ASSOCIATES, INC.
1505 n. fourth street
flagstaff AZ 86004
MDR Report Key10370835
MDR Text Key202007268
Report Number2017233-2020-01085
Device Sequence Number1
Product Code DSY
Combination Product (y/n)N
PMA/PMN Number
K880167
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 10/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberRRT08070080L
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 07/09/2020
Initial Date FDA Received08/05/2020
Supplement Dates Manufacturer Received07/09/2020
Supplement Dates FDA Received10/01/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
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