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

Catalog Number BXAL087902B

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/10/2022

Event Type  Injury  

Event Description

The following was reported to gore: on (b)(6) 2022, a patient presented for aaa procedure and treatment in the common iliac artery.As reported, an excluder® conformable aaa endoprosthesis with active control system and gore® excluder® iliac branch endoprosthesis (ibe) were utilized, in addition to a gore® viabahn® vbx balloon expandable endoprosthesis (vbx device).Post operative scans and fluoroscopy assessments showed a vbx device was dislodged and stuck between proximal ibe device and the aneurysmal sac, potentially causing a type iii endoleak.During treatment, the vbx device was advanced using a dsf1245 12fr gore® dryseal flex introducer sheath with hydrophilic coating out of the proximal ibe and therefore gate.After several attempts to advance the vbx device through the ibe, the physician decided against advancing the vbx device further.The vbx delivery catheter was withdrawn from the patient.The vbx device had dislodged from the delivery catheter, but it was not realized until post operative imaging was done.The procedure ended with the vbx device remaining in patient.The physician stated the type ii endoleak is contributed to the lumber arteries and/or the vbx device lodged between the proximal ibe and aneurysm sac.The excluder® conformable aaa endoprosthesis with active control system was implanted as intended.The aneurysm size was not changed.The patient tolerated the procedure.An intervention procedure is pending.

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.Device remains in patient at this time.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

B1 - both serious injury and malfunction were selected.

Manufacturer Narrative

B3: event description was updated with new information (intervention performed 11/21/2022).H6 - code f2301 was added.Intervention on (b)(6) 2022, required an additional device to pin the dislodged / constrained vbx device against the patient's vessel wall.

Event Description

The following was reported to gore: on (b)(6) 2022, a patient presented for aaa procedure and treatment in the common iliac artery.As reported, an excluder® conformable aaa endoprosthesis with active control system and gore® excluder® iliac branch endoprosthesis (ibe) were utilized, in addition to a gore® viabahn® vbx balloon expandable endoprosthesis (vbx device).Post operative scans and fluoroscopy assessments showed a vbx device was dislodged and stuck between proximal ibe device and the aneurysmal sac, potentially causing a type iii endoleak.During treatment in the patient's right leg, the vbx device was advanced using a dsf1245 12fr gore® dryseal flex introducer sheath with hydrophilic coating out of the proximal ibe and therefore gate.After several attempts to advance the vbx device through the ibe, the physician decided against advancing the vbx device further.The vbx delivery catheter was withdrawn from the patient.The vbx device had dislodged from the delivery catheter, but it was not realized until post operative imaging was done.The procedure ended with the vbx device remaining in patient.The physician stated the type ii endoleak is contributed to the lumber arteries and/or the vbx device lodged between the proximal ibe and aneurysm sac.The excluder® conformable aaa endoprosthesis with active control system was implanted as intended.The aneurysm size was not changed.On (b)(6) 2022, it was reported the constrained vbx device was secured against the patient's vessel.The physician also extended the main body flow divider to the right external iliac artery.The patient tolerated the procedure.

• 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: 15756238
• MDR Text Key: 304533368
• Report Number: 2017233-2022-03456
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): Y
• Reporter Country Code: AS
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: BXAL087902B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2021
• 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 Age: 84 YR
• Patient Sex: Male