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 Migration (4003)

Patient Problem Failure of Implant (1924)

Event Date 02/06/2024

Event Type  Injury  

Manufacturer Narrative

A1: no patient specific details have been provided.Therefore, the patient initials reflect the w.L.Gore internal case number.H6: code c19 - a review of the manufacturing records indicated the lot met pre-release manufacturing specifications.Code c21 - the device was returned to w.L.Gore and it is under engineering evaluation.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 Description

It was reported to gore that on (b)(6) 2024, a patient was to be implanted with a 6mm x 5cm gore® viabahn® endoprosthesis with heparin bioactive surface (vsx device) to treat the external carotid artery aneurysm.The device moved during the deployment process.The device was removed via open surgery.

Manufacturer Narrative

H6: code c19 - evaluation of received items: a) the returned device was determined to be consistent with the product listed within the complaint by means of labelling and device features.The delivery system was returned with no endoprosthesis mounted on the distal end of the catheter.A kink was observed on the distal shaft adjacent to the transition.An assessment of deployment performance was not possible with the items returned for evaluation.B) two photos were submitted by the field for review with similar content and field of view.The images were reviewed as part of the investigation and are consistent with the information gathered during the engineering evaluation.The images demonstrate a viabahn® device with a blue 0.035¿ compatible catheter labeled at the hub as a 6 mm x 5 cm stent-graft configuration.The device appears deployed with no endoprosthesis mounted on the distal shaft.No further information was obtained from the evaluation of the images.Code d15 - the reported primary device failure, related to partial deployment with partial expansion of the endoprosthesis, could not be independently confirmed with the items submitted for review.An independent assessment of deployment performance could not be conducted as the viabahn® device was returned deployed with no endoprosthesis present.The investigation could not establish the cause of the reported hazardous situation nor assign a primary device failure mode.The reported device failure concerning device movement during deployment could not be independently confirmed with the items available for review.The field reported device movement occurred after the physician had pulled on the deployment line with higher force.Therefore, the root cause of the deployment inaccuracy is consistent with use error as reported (i.E., user forcefully pulls the deployment knob and does not deploy in a smooth and consistent motion).The ifu instructs users to slowly pull the deployment knob during deployment of the viabahn® device and minimize catheter movement to ensure accurate positioning of the endoprosthesis.The field reported the viabahn® device was removed following surgical conversion; however, the root cause of the removal could not be identified with the available information.

• 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: qiong wang ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18956722
• MDR Text Key: 338305141
• Report Number: 2017233-2024-04732
• 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
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: VBHR060502W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2023
• 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 Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 65 KG