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

Catalog Number BXA085901A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Perforation of Vessels (2135)

Event Date 01/15/2024

Event Type  Death  

Event Description

The following was reported to gore: on (b)(6) 2024, a patient presented for bilateral treatment in the iliac arteries due to occlusive disease.As reported, the patient also had calcified arteries.In the common femoral arteries, 8fr cordis brite tip sheaths were placed and target lesions were pre-dilated.Over an.035 wire, an 8 x 29 gore® viabahn® vbx balloon expandable endoprosthesis (vbx device/balloon) was advanced and placed in the right common iliac artery.An 8 x 79 vbx device was also advanced over an.035 wire to the left common iliac artery.Using a kissing technique, both vbx devices were deployed.When the vbx balloons were deflated, it was realized the left external iliac artery had ruptured distal to the 8 x 79 vbx device.The bleeding was controlled temporarily by re-inflating the vbx balloon.Aiming to control the bleeding from the right side, the physician exchanged the 8fr cordis brite tip sheath for a 9fr sheath (brand unknown) to accommodate a coda® balloon catheter (coda balloon).However, the coda balloon did not fit through the 9fr sheath.The 9fr sheath was upsized to a 10fr sheath (unknown brand), but the coda balloon still did not fit through the 10fr sheath.The vbx balloon catheter was withdrawn from the left access and the 8 x 59 vbx device was advanced and deployed in the left external iliac artery, distal to the 8 x 79 vbx device.When the vbx balloon was deflated the patient started bleeding again and it was realized the rupture was not contained.The physician started removing the catheter with intention to implant a gore® viabahn® endoprosthesis with heparin bioactive surface (viabahn device).When pulled emergently the vbx balloon catheter broke outside the sheath, effectively blocking access and no way to re-inflate the vbx balloon.Consequently, the physician did a cut-down to expose the left external iliac artery in attempts to cover the perforation and re-gain control of the bleeding.The patient continued to bleed and eventually coded.The physician and staff tried to use resuscitation measures, but the patient expired.

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.A second medwatch report (2017233-2024-04604) was submitted for the second vbx device used (lot/serial # 24444090).Devices were implanted in same patient on same date/same procedure.H6 - code c19: review of device manufacturing record history confirmed device met pre-release specifications.H6 - code b20: device was deployed as intended and remained implanted.Engineering evaluation states the primary reported device failure related to withdrawal difficulty post deployment, could not be independently confirmed as no items were returned for evaluation.Therefore, a root cause could not be established with the available information.The break in the delivery catheter shaft during device withdrawal also could not be confirmed.However, the field reports the break occurred on the vbx device balloon catheter shaft outside of the sheath after the physician had pulled emergently on the delivery system.Therefore, the root cause of the broken catheter shaft is consistent with reasonably foreseeable misuse, specifically user applies excessive force to the delivery system (leading to extensive tensile load, twisting, or torsion load and compromised/broken delivery system).The ifu warns against the use of excessive force during withdrawal of the delivery system to prevent damage to the delivery catheter.Ifu for gore® viabahn® vbx balloon expandable endoprosthesis - deployment of the gore® viabahn® vbx balloon expandable endoprosthesis: while maintaining negative pressure in the balloon and the guidewire position across the treated lesion, carefully remove the delivery catheter from the body through the sheath or guide catheter.Moderate resistance may be felt when the balloon is withdrawn through the introducer sheath.Note: if, during catheter removal, the balloon catches on the leading edge of the introducer sheath, a slight ¿back and forth¿ motion of the catheter may aid in release.If needed, the delivery catheter and the sheath or guide catheter may be removed together as a unit.Excessive or abrupt force during catheter removal may damage the delivery catheter, or introducer sheath.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.

• Brand Name: GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS
• Type of Device: 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: genevieve begay ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18668269
• MDR Text Key: 334904105
• Report Number: 2017233-2024-04609
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/08/2024

1 Device was Involved in the Event

• Date FDA Received: 02/08/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: BXA085901A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/15/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/26/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial