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

Catalog Number VBHR080702A

Device Problem Activation Failure (3270)

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

Event Date 12/08/2023

Event Type  malfunction  

Event Description

On (b)(6) 2023, a patient underwent a fenestrated aortic abdominal aneurysm procedure where an 8 mm x 7.5 cm gore® viabahn® endoprosthesis with heparin bioactive surface (viabahn® device) was used in the left renal artery.It was reported the physician accessed the patient via the left groin using a 22f gore® dryseal flex introducer sheath.The viabahn® device delivery catheter was then advanced inside that sheath through a 12f terumo nagare bidirectional steerable sheath over an unknown size stiff guide wire to the target treatment site.Reportedly, the anatomy was tortuous and the delivery catheter had to travel a long distance and through other devices to the target treatment zone.In an attempt to deploy the endoprosthesis, the line was pulled and broke making a loud sound.The delivery system catheter, deployment line and sheath were withdrawn from the patient.The endoprosthesis was removed with partial distal expansion, but there were no fragments left in the patient.The physician does not know why the deployment line broke.The procedure was completed successfully using a different viabahn® device.It was reported that there was no impact to the patient.

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.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 entire vsx device was returned with the catheter still mounted on the delivery catheter.The deployment line was broken and the deployment knob with an attached deployment line segment were separated from the delivery system.The endoprosthesis was partially expanded at the distal end with full deployment of the outer zipper and partial deployment of the inner zipper.The endoprosthesis was also slightly distally compressed exposing a kinked distal shaft.The observed broken deployment line confirms the primary complaint of deployment difficulty (i.E.Broken deployment line).However, the root cause of the reported deployment failure with broken deployment line could not be established.Deployment of the returned vsx device continued when pulling the broken deployment line at the endoprosthesis, demonstrating that the deployment mechanism itself was not stuck.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.

• 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: 18608671
• MDR Text Key: 334792348
• Report Number: 2017233-2024-04576
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 00733132624065
• UDI-Public: 00733132624065
• 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
• Report Date: 01/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: VBHR080702A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/05/2023
• 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: 76 YR
• Patient Sex: Male