• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

W. L. GORE & ASSOCIATES, INC. GORE® PROPATEN® VASCULAR GRAFT; PROSTHESIS, VASCULAR GRAFT Back to Search Results
Device Problem Device Stenosis (4066)
Patient Problems Purulent Discharge (1812); Unspecified Infection (1930)
Event Date 02/23/2024
Event Type  Injury  
Manufacturer Narrative
The serial/lot number was requested and is unavailable.A review of the manufacturing records for the device could not be conducted because the serial/lot number remains unknown.The device was not returned to gore for direct analysis.No images were provided for evaluation.Therefore, an engineering evaluation could not be performed.According to the instruction for use for the gore® propaten® vascular graft, complications which may occur in conjunction with the use of any vascular prosthesis include but are not limited to: infection.Cbas® heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.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 information was reported to gore: on an unknown date, the patient was implanted with a gore® propaten® vascular graft (propaten vascular graft) as a venous-venous shunt for hemodialysis.The procedure date and the device information is unknown.One or two days post implantation, wound exudate was observed from the incision site approximately 1 mm away from the device.Frequent anastomotic stenosis occurred though it was unclear whether the stenosis was caused by the exudate.On february 7, 2024, the patient underwent an endovascular treatment for the anastomotic stenosis using gore® viabahn® endoprosthesis with heparin bioactive surface (viabahn device).Blood culture test was negative before the procedure.The viabahn device was implanted to repair the stenosis and the wound exudate.The viabahn device was implanted in a site with observed exudate.Symptomatic improvement was observed immediately after implantation.On (b)(6) 2024, purulent drainage was observed.It was confirmed infection at the site of the viabahn device.On (b)(6) 2024, a reintervention was performed and both propaten vascular graft and viabahn device were removed from the patient.Reportedly, there was a risk of infection since the patient had symptoms of exudate.The physician commented that the device placement to the exudate site may have been a mistake.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
GORE® PROPATEN® 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 Key18933807
MDR Text Key338030744
Report Number2017233-2024-04723
Device Sequence Number1
Product Code DSY
Combination Product (y/n)Y
Reporter Country CodeJA
PMA/PMN Number
K062161
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 03/19/2024
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 03/04/2024
Initial Date FDA Received03/19/2024
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 Age86 YR
Patient SexMale
-
-