MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number CEB231210

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problems Aneurysm (1708); Thromboembolism (2654)

Event Date 10/10/2022

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing records for the device verified the lot met all pre-release specifications.The device remains implanted and is not available for investigation.Images were sent to gore for analysis.Investigation is in process.Further information will be provided.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

On (b)(6) 2022, a patient presented for treatment in the common iliac artery.As reported, an excluder® conformable aaa endoprosthesis with active control system and a 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 dislodged and stuck between the proximal ibe device and the aneurysmal sac, potentially causing a type iii endoleak.According to the physician, a type ii endoleak from the lumber arteries and/or the vbx lodged at the proximal iliac branch endoprosthesis caused the problem.The excluder® conformable aaa endoprosthesis with active control system was implanted as intended.The physician mentioned that the aneurysm size was not changed.The patient is doing great.On (b)(6) 2022 was reported that a reintervention procedure is scheduled for (b)(6) 2022.Further information will be provided.Images were received for analysis.

Event Description

On (b)(6) 2022, a patient presented for treatment in the common iliac artery.As reported, an excluder® conformable aaa endoprosthesis with active control system and gore® excluder® iliac branch endoprostheses (ibe) were utilized, in addition to a gore® viabahn® vbx balloon expandable endoprosthesis (vbx device).

Manufacturer Narrative

A1: patient's id updated.B5: event description- iliac branch devices were used during the procedure.B6: on (b)(6) 2022, the imaging evaluation was completed.Please see result in b6.H6: code c19- a review of the manufacturing records for the device verified the lot met all pre-release specifications.The device remains implanted and is not available for investigation.Also was involved a gore® excluder® iliac branch endoprosthesis - internal iliac component (hgb/unknown).Per imaging evaluation, given the abnormalities of the deployed devices the evaluation can not conclude a type ii or type iii endoleak.According to the gore® excluder® iliac branch endoprosthesis instructions for use (ifu), adverse events that may occur and / or require intervention include, but are not limited to endoleak and occlusion of device or native vessel.In addition to standard evar anatomical considerations, additional anatomical considerations for placement of the gore® excluder® iliac branch endoprosthesis include, but are not limited to anatomic suitability for the endovascular repair.

Manufacturer Narrative

B5: the event description was updated for reintervention.C19- a review of the manufacturing records for the devices verified the lots met all pre-release specifications.The devices remain implanted and are not available for investigation.Also was involved a gore® excluder® iliac branch endoprosthesis - internal iliac component (b)(4).Udi# (b)(4).Per imaging evaluation, given the abnormalities of the deployed devices the evaluation can not conclude a type ii or type iii endoleak.According to the gore® excluder® iliac branch endoprosthesis instructions for use (ifu), adverse events that may occur and / or require intervention include, but are not limited to endoleak and occlusion of device or native vessel.Users are made aware of the risks associated with type ii endoleaks in the ifu and are instructed to consider the risks and benefits discussed in the ifu for each patient before using the devices.Additional considerations for patient selection include but are not limited to patient¿s anatomical suitability for endovascular repair.Successful exclusion of the aneurysm(s) may be affected by significant thrombus at the distal iliac artery interfaces.Irregular plaque may compromise the fixation and sealing of the implantation sites.

Event Description

On (b)(6) 2022, a reintervention was performed.The physician extended the gore® excluder® iliac branch endoprosthesis to the right external iliac artery.The patient tolerated the procedure.

• Brand Name: GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL SILICON VALLEY B/P; 2890 de la cruz blvd.; santa clara CA 95050
• Manufacturer Contact: nataliya baramzina ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15762086
• MDR Text Key: 303348787
• Report Number: 3013164176-2022-01534
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: CEB231210
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/02/2022
• Initial Date FDA Received: 11/09/2022
• Supplement Dates Manufacturer Received: 11/11/2022; 11/27/2022
• Supplement Dates FDA Received: 11/15/2022; 12/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2022
• 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
• Patient Outcome(s): Required Intervention; Other; Hospitalization
• Patient Age: 84 YR
• Patient Sex: Male