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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Obstruction/Occlusion (2422); Restenosis (4576)

Event Date 05/07/2021

Event Type  Injury  

Manufacturer Narrative

A1: no patient specific details have been provided.Therefore, the patient initials reflect the w.L.Gore internal case number.C1: heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.H6 code b14: a review of the manufacturing records couldn't be performed because the serial number is unknown.H3 and h6 code b20: the device remains implanted in the patient.Therefore a device evaluation could not be performed.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

Reportedly on (b)(6) 2021, this patient underwent an endovascular repair of a thoracoabdominal aneurysm ii which was treated with a fenestrated and branched stent graft component.During the procedure planning, it was determined that the celiac trunk, superior mesenteric artery, right and left renal artery will be incorporated in the fenestrated and branched endograft.A gore® viabahn® vbx balloon expandable endoprosthesis were implanted in the celiac trunk.Reportedly, the whole procedure was eventful, aortic access was successfully gained, however the device was not deployed as intended.The catheters were successfully removed and the patency of the device was patent at the end of the procedure.The patient received an additional antiplatelet medication during the procedure.According to reports, on (b)(6) 2022, during a clinical follow a computed tomography angiography was performed and it was discovered that the celiac trunk was occluded unintentionally by a vbx.Reportedly it was mentioned that the vbx was stuck in the native stenosis of the celiac trunk.The physician indicated that they didn't realize this during the removal of the catheter because they thought that the stent was still on the balloon, because the balloon for the vbx is white (same color as the stent).The physician emphasized that the stent was not taken out, instead it was stuck in the stenosis of the celiac trunk as a plug.Reportedly on (b)(6) 2023, a repeat intervention was performed.Additionally, the physician indicated that a persistent type ii endoleak remained from the celiac (via the sma).The celiac trunk was retrogradely accessed and coil embolized thus treating the endoleak.

Manufacturer Narrative

A1: no patient specific details have been provided.Therefore, the patient initials reflect the associated study number.Emdr section h6 codes updated to reflect results of investigation.

Manufacturer Narrative

Emdr section h6: codes updated to reflect results of investigation.

• 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: samir kulovic ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17341020
• MDR Text Key: 319397143
• Report Number: 2017233-2023-04120
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): Y
• Reporter Country Code: DA
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other
• Patient Age: 73 YR
• Patient Sex: Male