MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS; PRL / ILIAC COVERED STENT, ARTERIAL

Catalog Number BXA087902E

Device Problems Physical Resistance/Sticking (4012); Premature Separation (4045)

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

Event Date 07/14/2023

Event Type  malfunction  

Manufacturer Narrative

A1: no patient specific details have been provided.Therefore, the patient initials reflect the w.L.Gore internal case number.C1: cbas® heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.H6 evaluation codes type of investigation: b13: additional information in regard to the event of the case was requested from the physician.The provided additional information is captured in the event description in section b5.B18: the device was discarded at the treating facility and therefore not available for 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

It was reported to gore that the patient underwent endovascular treatment for a bridge stent-graft in a complex aortic procedure with 2 gore® viabahn® vbx balloon expandable endoprostheses (vbx-devices) from the branch to the superior mesenteric artery (sma).The vbx-devices (item bxa097902e lot 26664942 and item bxa087902e lot 25323782) were not implanted because the stent-grafts disconnected from the balloon catheters when the vascular surgeon tried to retract the endoprostheses into a steerable introducer sheath (lifetech fustar 10 fr 70 cm).The vascular surgeon had positioned the steerable introducer sheath (lifetech fustar 10 f 70 cm) with 150° curvature in the aortic stent-graft already implanted (cook custom-made branch device) and he had cannulated the target vessel (sma) through the dedicated branch with a.035'' guidewire (cook rosen).He advanced the item bxa097902e (lot 26664942) through the steerable introducer sheath and outside, then he needed to remove it without delivering the stent-graft since he lost the guidewire from the target vessel.He didn't remove the steerable introducer sheath together with the endoprosthesis in order to maintain the access.When he removed the balloon catheters from the introducer valve, the stent-graft was moving on the balloon and the physician decided not using it anymore: the item bxa097902e (lot 26664942) is available for return.Then he repeated the cannulation of the same target vessel (sma) and advanced the item bxa087902e (lot 25323782) through the steerable introducer sheath and outside, but again he needed to remove it without delivering the stent-graft since he lost the guidewire from the target vessel.He felt a big resistance at the tip of the steerable introducer sheath and the stent-graft disconnected from the balloon catheter and remained inside the steerable introducer sheath, that was removed: the item bxa087902e (lot 25323782) was discarded together with the steerable introducer sheath.The vascular surgeon completed the procedure with another vbx-device using a new steerable introducer sheath (lifetech fustar 10fr 70cm) on the same guidewire (cook rosen), without any complication.

Manufacturer Narrative

H6 evaluation codes investigation findings c19 refers to the product history review: a review of manufacturing records verified that the lot involved in this complaint met all pre-release specifications.The vbx device was discarded at the treating facility, and no items were available to directly evaluate product performance relative to the reported device failure mode.Reported dislodgment of the endoprosthesis from the delivery balloon catheter could not be independently confirmed in this investigation as no items, including product or clinical images, were returned for a direct assessment of product performance.The physician reported retraction of the vbx device through a steerable introducer sheath following procedural difficulties with guidewire access.Withdrawal of an undeployed vbx device through a sheath is a reasonably foreseeable misuse consistent with the reported dislodgement of the endoprosthesis.Therefore, the root cause is consistent with unintended use error as reported, specifically user tries to remove delivery system with stent still mounted leading to the potential for stent migration.The gore® viabahn® vbx balloon expandable endoprosthesis instructions for use (ifu), for the appropriate region and time-period, was reviewed with respect to the complaint detail and there are applicable statements.The ifu states the following: ¿do not withdraw the gore® viabahn® vbx balloon expandable endoprosthesis back into the introducer sheath once the endoprosthesis is fully introduced.Withdrawing the gore® viabahn® vbx balloon expandable endoprosthesis back into the sheath can cause dislocation and / or damage to the endoprosthesis, premature deployment, deployment failure, and / or catheter separation.If removal prior to deployment is necessary, withdraw the gore® viabahn® vbx balloon expandable endoprosthesis to a position close to but not into the introducer sheath.Both the gore® viabahn® vbx balloon expandable endoprosthesis and introducer sheath can then be removed in tandem.¿.

Manufacturer Narrative

Previously reported conclusion code d12 does not apply in the present event because the user did not take all reasonable mitigation steps, evidenced by conclusion code d1102.Therefore d12 was removed from section h6.

• Brand Name: GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS
• Type of Device: PRL / ILIAC COVERED STENT, ARTERIAL
• 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: kerstin haberlaender ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17404968
• MDR Text Key: 319869859
• Report Number: 2017233-2023-04147
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): Y
• Reporter Country Code: IT
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: BXA087902E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2022
• 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: GUIDEWIRE ROSEN (COOK) 0.035" 260CM.; STEERABLE SHEATH FUSTAR (LIFETECH) 10F 70CM.