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

Catalog Number PAJR081002E

Device Problems Fracture (1260); Premature Activation (1484); Activation Failure (3270)

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

Event Date 03/05/2024

Event Type  malfunction  

Event Description

It was reported to gore that the patient underwent surgical treatment for repair of the femoral tripod.The iliac artery was stented and the surgeon repaired the tripod with a surgery.There were some blood clots, which were removed with a fogarty catheter.There was infection and after there was a rupture from the tripod and the surgeon decided to use a gore® viabahn® endoprosthesis with propaten bioactive surface (vsx-device) to repair this situation.When the nurse put out the vsx-device from the packaging, the device was not like the other time, as there was a plicature between the catheter and the vsx.It was difficult to purge it but the nurse did it with success.The surgeon used a 0,014 command guide wire from abbott and a 7fr cordis sheath.He felt a resistance and it was impossible to move the vsx-device at the right area.He decided to remove it, to change the guide wire and to use a stiffer guide wire (no problem to do that).When the vsx-device was outside, he saw that it was already partially deployed.He confirmed that he didn't touch the wheel to begin the deployment.Another vsx-device (8x100) was used and could be implanted successfully.There was no report of patient harm.

Manufacturer Narrative

A1: no patient specific details have been provided.Therefore, the patient initials reflect the w.L.Gore internal case number.A2/a4: the patients age and weight was requested from the physician, but not provided.B7: patient history was requested but not provided.H3: other code: the device is still in the hospital, but will be returned for further investigation.H6 evaluation codes investigation findings c19 refers to the product history review: a review of the manufacturing records indicated the device met pre-release specifications.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

Engineering investigation: the primary reported device failure mode of a device kink could not be independently confirmed through engineering evaluation of the returned device because the device was returned in two pieces.The distal shaft is broken adjacent the transition, and the broken distal shaft is consistent with the reported device kink which may have subsequently broken during procedural manipulation, but this sequence could be neither confirmed nor dismissed with the available information.The cause for the reported device kink and the confirmed broken distal shaft could not be established.The vsx device instructions for use instruct users to inspect the device for damage, including kinks, prior to use, and to not use the device if the catheter shaft is kinked to avoid increased advancement force and/or catheter breakage.The reported device kink was observed upon removal of the device from the packaging, and use of the device reportedly continued.The reported complaint indicates the device was difficult to purge and to insert over the guidewire, and these two reported observations are also consistent with use of a kinked device as reported.The complainant reported premature and partial deployment of the device which was observed upon withdrawal of the device from the patient.Partial deployment was confirmed through evaluation of the both the returned device and the images provided.Premature and partial deployment can occur through a device interaction during attempted withdrawal, an interaction that is consistent with the confirmed broken distal shaft, but the cause for the reported premature and partial deployment could not be established with the available information.The vsx device ifu was reviewed with respect to the complaint detail for the applicable region and time period.The following ifu statements were identified as related to the primary device failure mode in this complaint.Warnings do not use a kinked introducer sheath or catheter shaft.A kinked introducer sheath or catheter shaft may increase the force necessary to advance or deploy the endoprosthesis and may cause a deployment failure or catheter breakage.3.Inspection prior to use.A.Prior to using the gore® viabahn® endoprosthesis with propaten bioactive surface, all materials and equipment to be used for the procedure should be carefully examined for bends, kinks, or other damage.B.Do not use any defective equipment.

• 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: gunter marte ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18949486
• MDR Text Key: 339320242
• Report Number: 2017233-2024-04725
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): Y
• Reporter Country Code: FR
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PAJR081002E
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/23/2024
• Initial Date FDA Received: 03/21/2024
• Supplement Dates Manufacturer Received: 04/10/2024
• Supplement Dates FDA Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/14/2023
• 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
• Treatment: FOGARTY CATHETER.
• Patient Outcome(s): Required Intervention