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

Catalog Number BXA103901J

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Perforation of Vessels (2135)

Event Date 12/21/2022

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.Patient weight was requested, but not made available.Patient's medical history and medication information was requested but not made available.Device evaluated by mfr: the explanted devices were discarded at user facility.Therefore, direct product analysis was not possible.(b)(4).Additional device implanted during same procedure / same anatomical location was: lot/serial #(b)(4) bxa115901j; udi #(b)(4).Manufacturing report #2017233-2023-03633 was submitted.A total of four gore® viabahn® vbx balloon expandable endoprostheses were implanted during same procedure.Two devices were implanted in overlapped fashion in right leg; two devices were implanted in right leg.Ifu for gore® viabahn® vbx balloon expandable endoprosthesis hazards and adverse events procedure related: as with all procedures that utilize techniques for introducing a catheter into a vessel, complications may be expected.These complications include, but are not limited to: access site infection; entry site bleeding and/or hematoma; vessel thrombosis, occlusion, pseudoaneurysm, and trauma to the vessel wall (including rupture or dissection); distal embolization; arteriovenous fistula formation; transient or permanent contrast induced renal failure; renal toxicity; sepsis; shock; radiation injury; myocardial infarction; fever; pain; malposition; malapposition; inflammation; and/or death.Device related: complications and adverse events can occur when using any endovascular device.These complications include, but are not limited to: hematoma; stenosis, thrombosis or occlusion; distal embolism; side branch occlusion; vessel wall trauma and/or rupture; false aneurysm; infection; inflammation; fever and/or pain in the absence of infection; deployment failure; migration; and device failure.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 information was reported to gore: on (b)(6) 2022, a patient underwent an endovascular treatment due to progression of peripheral arterial disease in bilateral iliac arteries (aortic bifurcation).From both femoral arteries, access was gained and asahi intecc, 0.018 treasure floppy wires were inserted on both sides.Pre-ballooning was done using a 5 mm x 10 cm cordis saber plus a 7 mm x 40 mm 35shiden hp (kaneka ).Using an 8fr x 40cm terumo long sheath, two gore® viabahn® vbx balloon expandable endoprostheses (vbx device) were implanted using a kissing technique.After deployment of the two vbx devices, a confirmation angiography showed bleeding from the aorta or iliac artery.Blood vessel perforation was suspected.Two additional vbx devices were implanted proximal to the initial vbx devices.The vbx devices were balloon inflated again.However, the bleeding did not disappear.The patient was transferred to an operating room, and afx bifurcated endograft, gore® excluder® aaa endoprostheses (contralateral leg and aortic extender), plus a vela proximal endograft were implanted.However, the bleeding continued.Consequently, all devices were explanted.As of (b)(6) 2022, the patient was reported to be recovering well from the surgical procedure.The physician stated the vessel rupture likely occurred when the vbx devices were deployed.He also stated the perforation was due to patient¿s condition (non-compliant anatomy), not because of vbx device performance.The edges of the first vbx devices were well fitted to the vessel wall but the bleeding through the collateral flow did not stop.Aorta-iliac region was highly calcified.The physician stated open surgery should have been first consideration.Guidewires or sheaths were not related to the perforation as there was no angiography findings suggestive of perforation after pre-ballooning.

• 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: 16134479
• MDR Text Key: 307061900
• Report Number: 2017233-2023-03634
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): Y
• Reporter Country Code: JA
• 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: 01/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: BXA103901J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/11/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male