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

Catalog Number PAHR051502K

Device Problems Entrapment of Device (1212); Premature Activation (1484); Difficult to Advance (2920)

Patient Problem Failure of Implant (1924)

Event Date 03/18/2024

Event Type  Injury  

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.Review of device manufacturing record history is currently being reviewed.Device was discarded at user facility.Therefore, direct product analysis is not possible.No images were provided to enable further investigation.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: during treatment for a femoropopliteal artery occlusion, a 5x15 gore® viabahn® endoprosthesis with propaten® bioactive surface (viabahn device) was to be implanted.The femoral access was not viable so the a 7fr introducer sheath (unspecified brand) was inserted through a retrograde route from on a tibial arterial access.The tibial artery was found stenosed and while attempting to pass the viabahn device through the introducer sheath, the viabahn device got stuck at the distal part of the introducer sheath.There was partial, unintended expansion of the vsx device distal of the introducer shaft.Because the viabahn device was stuck, a cutdown was necessary to remove the viabahn device and the sheath.The procedure continued and a 7fr introducer hfan sheath was placed and the vessel was ballooned prior to insertion of the new viabahn device.Two viabahn devices (5x15 and 6x15 ) were implanted in the femoropopliteal region successfully.The physician stated the first viabahn device was not implanted because of a technical failure.The patient is reported to be recovering well.

Manufacturer Narrative

H6: code c19: review of device manufacturing record history confirmed device met pre-release specifications.Engr: the primary reported device failure, related to advancement failure through a sheath, could not be independently confirmed as no items were returned for evaluation.No incompatibilities in accessory device selection, including sheath size, were identified.The field reported the tibial artery access vessel was stenosed, and the reported information suggests pre-dilation ballooning was not performed during initial advancement of the viabahn® device.Therefore, the root cause of the advancement failure is consistent with use error as reported (i.E., user does not perform pta).The ifu directions for use include performing pta if treating stenotic or occlusive lesions prior to insertion of the viabahn® device.The reported device failure, related to premature device expansion, also could not be confirmed in the absence of items for review.Unintentional line unravel is consistent with unintended device interactions between the viabahn® device and sheath interface during the reported advancement difficulties.However, neither the timing of occurrence nor cause of the unintended device expansion could be independently established with the available information.The gore® viabahn® endoprosthesis with propaten bioactive surface instructions for use (ifu) states: percutaneous transluminal angioplasty (pta) (if treating stenotic or occlusive lesions) refer to manufacturer¿s directions for use.Inflate the angioplasty balloon to its nominal pressure according to manufacturer¿s directions for use.Ensure full expansion of the balloon within the lesion.Following deflation of the angioplasty balloon, evaluate the results angiographically.For reference, measure the native vessel diameter, lesion length, and residual percent stenosis.

• 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: genevieve begay ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 19146695
• MDR Text Key: 340676887
• Report Number: 2017233-2024-04854
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): Y
• Reporter Country Code: BR
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PAHR051502K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2023
• 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 Sex: Female