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

Catalog Number VBJR050702A

Device Problems Break (1069); Activation Failure (3270)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/30/2024

Event Type  malfunction  

Event Description

On january 30, 2024, a patient underwent distal vein arterialization (dva) treatment for chronic limb threatening ischemia (clti) using a 5 mm x 7.5 cm gore® viabahn® endoprosthesis with heparin bioactive surface (viabahn® device) in a native peripheral arteriovenous fistula in the foot.It was reported the physician advanced a viabahn® device antegrade down the popliteal artery.This endoprosthesis deployed without incidence.A second endoprosthesis was advanced via pedal access around the heal and up through the plantar vein using a terumo 5f - 6f (outer and inner diameters respectively) glidesheath slender® hydrophilic coated introducer sheath over an 0.018" v-18¿ controlwire¿ guidewire.Reportedly, during deployment, the line was pulled and the deployment line broke and the endoprosthesis partially deployed.On one image point it appeared the endoprosthesis expanded hub to tip, with the distal portion remaining constrained.However, the progression of expansion was not observed under fluoroscopy.An additional wire was advanced and a balloon was used to pop the endoprosthesis open.During withdrawal it was difficult to get the olive tip out, but eventually it was wiggled free.It was reported there were no fragments left in the patient.It was reported that there was no impact to the patient.

Manufacturer Narrative

A review of the manufacturing records indicated the lot met all pre-release specifications.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.

Manufacturer Narrative

Engineering evaluation: a single clinical image was returned with no patient identifiers or date, and the image could not be manipulated in any way for further analysis, thereby limiting investigative outcomes.Other imaging, including live fluoroscopy video, was requested but was unavailable.The broken deployment line, could not be independently confirmed with the imaging item submitted for review.The root cause of the reported broken deployment line could not be determined following review of the clinical image.Partial deployment of the viabahn® device may be consistent with imaging findings demonstrating a distal or tip end of the endoprosthesis that appeared constrained.Root cause could not be established from review of the available information, including imaging evaluation.Further information, including direction of expansion, could not be deduced from a single image time point; therefore, the allegation of hub to tip expansion could not be independently confirmed.Additionally, the field indicated the progression of expansion was not directly observed under fluoroscopy.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
• Type of Device: 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: 18767707
• MDR Text Key: 336114533
• Report Number: 2017233-2024-04656
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: VBJR050702A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/30/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Sex: Male