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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE-TEX® STRETCH VASCULAR GRAFT; PROSTHESIS, VASCULAR GRAFT

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W. L. GORE & ASSOCIATES, INC. GORE-TEX® STRETCH VASCULAR GRAFT; PROSTHESIS, VASCULAR GRAFT Back to Search Results
Device Problem Fluid/Blood Leak (1250)
Patient Problems Aneurysm (1708); Seroma (2069)
Event Date 05/17/2023
Event Type  Injury  
Manufacturer Narrative
Device lot/serial information could not be obtained.Therefore, no manufacturing evaluation could be performed.The device was not returned to w.L.Gore & associates, inc.Consequently, a direct product analysis was not possible.According to gore-tex® stretch vascular graft instructions for use: the possible complications with the use of any vascular prosthesis: ultrafiltration or perigraft seroma, and formation of pseudoaneurysms.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: a gore-tex® stretch vascular graft (y graft) was implanted to treat an abdominal aortic aneurysm about 13 years ago.On (b)(6) 2023, a seroma occurred from a gore-tex® stretch vascular graft and this seroma formed an aneurysm which was about 100cm.The seroma was resected by open surgery and a stent graft was implanted in the y graft.
 
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Brand Name
GORE-TEX® STRETCH VASCULAR GRAFT
Type of Device
PROSTHESIS, VASCULAR GRAFT
Manufacturer (Section D)
W. L. GORE & ASSOCIATES, INC.
1505 n. fourth street
flagstaff AZ 86004
Manufacturer (Section G)
MEDICAL WEST B/P
1505 n. fourth street
flagstaff AZ 86004
Manufacturer Contact
amy mckeown
1505 n. fourth street
flagstaff, AZ 86004
9285263030
MDR Report Key16992709
MDR Text Key315861369
Report Number2017233-2023-03957
Device Sequence Number1
Product Code DSY
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K903931
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 05/24/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/17/2023
Initial Date FDA Received05/24/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age75 YR
Patient SexMale
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