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

Catalog Number VBHR060502W

Device Problem Separation Failure (2547)

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

Event Date 09/14/2022

Event Type  malfunction  

Manufacturer Narrative

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

The following was reported to gore: on (b)(6), 2022, a patient was implanted with a 6mm x 5cm gore® viabahn® endoprosthesis with heparin bioactive surface (viabahn device) to treat as chimney of right renal artery for abdominal aorta reconstruction.After the viabahn device was advanced 7fr cook long sheath to target lesion, the physician pulled the deployment knob to deploy viabahn device.When the viabahn device was expanded around 4.5cm and stuck, it was found the deployment line twist near anchor of aorta stent.The physician rotated and adjusted delivery system and pulled deployment line with multiple attempts, the viabahn device was successfully expanded.However, the deployment line was still twist and attached.Finally, the physician cut the deployment line.A remaining part of deployment line was fixed on the blood vessel, and the delivery system was retrieved.The patient tolerated the procedure.

Manufacturer Narrative

H6: c19: an imaging evaluation of the returned items was performed by a clinical imaging specialist.The videos received could not be used to perform a full imaging evaluation because they do not meet the dicom standard.Therefore, the extent and accuracy of the observations and findings were limited due to the completeness, format and/or quality of the items provided for review.Deployment line fragments in the patient could not be confirmed.The reported primary device failure mode of partial deployment due to a stuck deployment line could not be independently confirmed from evaluation of the returned items for review.The event details report an unintended deployment line interaction with an aortic main body stent-graft involved in the procedure.Ifu guidelines warn the user of potential deployment failure or malfunction during deployment of the viabahn® device within other non-viabahn devices.The complaint details describe deployment difficulty with subsequent full expansion of the viabahn® device after adjustment of the delivery system.The complainant also indicated the deployment line was twisted and attached near an anchor of the aortic device during attempted withdrawal of the delivery system.Therefore, the partial deployment due to a stuck deployment line and withdrawal difficulty are consistent with unintended device interactions that occurred during the procedure.The physician was reported to have cut the deployment line, and deployment line was reported to have remained within the vessel.However, neither the cause nor nature of the deployment line remnant could be independently evaluated with the available information.Cbas® heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.

• 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: pixie xi ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15483746
• MDR Text Key: 304532942
• Report Number: 2017233-2022-03349
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): Y
• Reporter Country Code: CH
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: VBHR060502W
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 65 KG