MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® VIABAHN® ENDOPROSTHESIS; STENT, SUPERFICIAL FEMORAL ARTERY

Catalog Number	VBCR071501A
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	12/08/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The following information was reported to gore: on (b)(6) 2023, a gore® viabahn® endoprosthesis (vsx device) was intended for use in the forearm during treatment of venous outflow stenosis.During the advancement of the vsx device though an 8fr merit introducer sheath over a 0.053" merit guide wire, the vsx device had become stuck approximately halfway into the vessel and the introducer sheath.With no device expansion the physician was unable to retract the vsx device back through the introducer sheath.The physician made the decision to perform a surgical removal.The patient did not experience any adverse consequences.
Additional 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.
Additional Manufacturer Narrative
Manufacturing records were reviewed, and the device met all pre-release specifications.There were no items (e.G.Clinical images, device return) provided in association with this complaint to allow direct evaluation of the vsx device performance relative to the reported failure mode of becoming stuck int the introducer sheath.The root cause of vsx device becoming stuck when advancing through the end of the introducer sheath and the reported inability to withdraw the vsx device through the introducer sheath as reported could not be established with the information available.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: nick lafave ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18412759
• Report Number: 2017233-2023-04514
• Device Sequence Number: 21010183
• Product Code: NIP
• UDI-Device Identifier: 00733132623471
• UDI-Public: 00733132623471
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P040037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/25/2026
• Device Catalogue Number: VBCR071501A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2023
• Supplement Date Received by Manufacturer: 02/21/2024
• Initial Report FDA Received Date: 12/28/2023
• Supplement Report FDA Received Date: 02/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 62 YR
• Patient Sex: Male