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

Model Number VBHR101502A

Device Problems Fracture (1260); Malposition of Device (2616)

Patient Problem Obstruction/Occlusion (2422)

Event Date 07/12/2023

Event Type  Injury  

Event Description

On (b)(6) 2023, a patient underwent treatment for an aneurysm in the popliteal artery in the left leg utilizing a gore® viabahn® endoprosthesis with heparin bioactive surface (viabahn device).It was reported the physician performed usual runoffs determining sufficient distal runoff and to determine the location of the aneurysm.Intravascular ultrasound (ivus) imaging was then performed to select the viabahn device size.Reportedly, the proximal vessel diameter was 9 mm, therefore a 10 mm x 15 cm viabahn device was selected.Reportedly, the physician accessed the patient contralaterally via the femoral artery.Since the device required an 8f sheath, the decision was made to deploy the stent without a sheath over a.035" amplatz guide wire.The stent passed completely into the vessel, however resistance was met just proximal to the aortic bifurcation and it would not advance any further.An attempt to withdraw the device was made.The delivery catheter was withdrawn, but the stent-graft with the deployment line still attached remained in the patient's common iliac artery.The decision was made to deploy the device.Under fluoroscopy, it was confirmed the stent-graft deployed successfully, however the hypogastric artery was covered.Reportedly, the physician was not concerned about the unintended coverage.Fluoroscopy imaging also showed a distal tip radiopaque marker inside the patient.The previously withdrawn delivery catheter was examined, confirming approximately 15 centimeters, from the deployment line hole to the distal tip, was still inside the patient.Reportedly, the physician advanced an 8f sheath and successfully captured the broken delivery catheter inside the sheath.The sheath and the guidewire were withdrawn along with the broken delivery catheter fragment.The viabahn device was then post-dilated.The procedure was completed by advancing an 8f sheath and deploying a viabahn device (8 mm x 15 cm) in the intended target treatment zone (popliteal artery).This device was also post-dilated.Angiography was completed on both implant locations and everything looked satisfactory.

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.

Manufacturer Narrative

A review of the manufacturing records indicated the device met pre-release specifications.Product return evaluation: the returned vsx device was observed to be consistent with the product listed within the complaint.The distal shaft was observed to the separated from the delivery catheter at the transition, with noticeable compressive bunching of the woven steel braid and outer green pebax layer of the distal shaft.An exposed inner yellow polymer tube on the proximal end of the distal shaft with visible damage and tears was also observed.Deformation was observed at the deployment notch.The primary complaint of difficulty advancing the device to the target location could not be independently confirmed as the conditions present during the procedure cannot be replicated during device evaluation.The report of separation of the distal shaft from the delivery catheter was confirmed.The root causes of distal shaft separation and the observed deformation of the deployment notch at the transition of the delivery catheter are consistent with compressive axial forces along the catheter during manipulation at the time of procedure, though the specific mechanism is unknown.The observations of bunching and visible tears at the proximal end of the distal shaft indicate that a bond between the catheter and distal shaft was present prior to procedure.

• 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: 17333574
• MDR Text Key: 319346711
• Report Number: 2017233-2023-04112
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 00733132646067
• UDI-Public: 00733132646067
• 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: 09/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VBHR101502A
• Device Catalogue Number: VBHR101502A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2022
• 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 Outcome(s): Other
• Patient Age: 73 YR
• Patient Sex: Male