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

Catalog Number	VBJR080502A
Medical Device Problem Codes	Activation Failure (3270); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 or Problem Description
On (b)(6) 2024, a patient underwent a procedure for stenotic occlusion where a 8 mm x 5 cm gore® viabahn® endoprosthesis with heparin bioactive surface (gore® viabahn® device) was intended to be used in the right external iliac artery.It was reported the lesion was predilated and prepped using an 6 x 10 penumbra device.The physician accessed the patient ipsilaterally.The delivery catheter was advanced using a 12f cook sheath over an unknown size terumo glidewire advantage® peripheral guidewires to the target treatment zone.It was reported they used a 12f sheath due to the use of the penumbra device during preparation.Reportedly, there was no resistance noticed during advancement of the delivery catheter.During deployment, the line was pulled, and the deployment line broke approximately 2 cm from the proximal end of the stent.It was reported the deployment line was pulled using the normal technique.The delivery catheter was removed from the patient with the endoprosthesis fully constrained.Reportedly, there were no catheter fragments or deployment line left in the patient the physician does not have any suspicions as to why the line became broke.The procedure was completed using another 8 mm x 5 cm gore® viabahn® device.It was reported there were no consequences or impact to patient.
Additional Manufacturer Narrative
H6: updated codes based on investigation.A review of manufacturing records verified that the lot involved in this complaint met all pre-release specifications.Product return evaluation: the returned device was deemed consistent with the product listed within the complaint.Evaluation of the returned device indicates the knob detached from the hub with section of broken deployment line.Another section of broken deployment line present at the endoprosthesis without partial deployment of outer zipper.Guidewire inserted for deployment passed through to transition.Initial deployment attempt by pulling on section of broken deployment line at the endoprosthesis was unsuccessful.A loose fiber of deployment line was observed after initial deployment attempt.After gentle manipulation of deployment line, deployment continued with traction on deployment line at the endo.After second deployment attempt, damage to deployment line was observed.The reported failure mode of broken deployment line is consistent with the findings during engineering evaluation.The root cause of the broken and stuck deployment line could not be established with the available information.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
• 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: jorja nackard ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 20675749
• Report Number: 2017233-2024-05486
• Device Sequence Number: 12992626
• Product Code: NIP
• UDI-Device Identifier: 00733132623815
• UDI-Public: 00733132623815
• Combination Product (Y/N): Y
• Initial Reporter State: SC
• 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): 11/25/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: VBJR080502A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/13/2024
• Supplement Report FDA Received Date: 11/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2024
• 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
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 89 KG