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

Model Number HGB161407A

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/28/2022

Event Type  malfunction  

Manufacturer Narrative

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 emergently with a ruptured left common iliac aneurysm.The physician's treatment option was going to be to preserve the internal iliac with ibe.A gore® excluder® iliac branch endoprosthesis ceb was inserted and primary deployment was performed.A gore® excluder® iliac branch endoprosthesis hgb was deployed into the internal iliac without issue.Upon removing device catheter the leading olive was dislodged from the catheter.The fsa believes that the leading olive was caught in wire wrap.The device delivery catheter was removed and discarded.Final result was favorable and patient is doing well.

Manufacturer Narrative

Imaging evaluation summary: the images received cannot be used to perform a full imaging evaluation because they do not meet the dicom standard.The extent and accuracy of the observations and findings may be limited due to the completeness, format and/or quality of the images provided for review.Gore cannot guarantee the images provided are complete, accurate or lack alteration.Therefore, gore cannot guarantee all key findings have been captured or that the findings are accurate.The imaging evaluation performed by a clinical imaging specialist showed the following: images received via email with no patient identifier or date of acquisition in image.Unable to confirm leading end of catheter broken and catheter withdrawal interference with available image.Engineering evaluation summary: the gore® excluder® iliac branch endoprosthesis hgb161407a was not returned for analysis.The device evaluation was performed based on what was reported to gore and the imaging evaluation attached to the event as the device¿s delivery catheter was not returned for evaluation.The imaging evaluation was unable to conclude that the leading end of the catheter was broken, and the catheter had withdrawal interference with the available image.The likely cause for the reported observation could not be determined with the currently available information.However, the reported wire wrap may have contributed to the reported leading olive detachment.The excluder iliac branch endoprosthesis instructions for use (ifu) states: visually verify the throughwire is not wrapped around the ibc guidewire or delivery catheter.If wire wrap is observed, rotate the ibc device and delivery catheter to resolve.

• 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: greg rawlings ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15478542
• MDR Text Key: 306256953
• Report Number: 3013164176-2022-01486
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132635337
• UDI-Public: 00733132635337
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 12/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HGB161407A
• Device Catalogue Number: HGB161407A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/29/2022
• Initial Date FDA Received: 09/24/2022
• Supplement Dates Manufacturer Received: 12/01/2022
• Supplement Dates FDA Received: 12/01/2022
• Date Device Manufactured: 03/23/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 43 YR
• Patient Sex: Male
• Patient Weight: 245 KG