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

Catalog Number HGB161007

Device Problems Material Fragmentation (1261); Material Separation (1562)

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

Event Date 10/04/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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

It was reported to gore that a gore® excluder® iliac branch endoprosthesis was used to treat a patient with abdominal aortic aneurysm and aneurysm in the right common iliac artery.After device was deployed, the physicians started trying to retrieve the device catheter.Some resistance was felt and when the full catheter was out, it was realized that the proximal part/rod (including the proximal olive) was missing and stayed behind in the hypogastric branch.The physician tried to retrieve it with a snare but it was impossible and the piece stayed inside of the patient's artery.The patient is doing fine.

Manufacturer Narrative

B15 - the images received cannot be used to perform a full imaging evaluation.The extent and accuracy of the observations and findings may be limited due to the completeness, format and/or quality of the available images provided for review.Gore cannot guarantee the images provided are 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: three jpgs submitted for evaluation, these images were received via (email) with no patient identifier or date of acquisition in image.The third image in the series reported to gore appears to show a leading olive no longer over the wire and not attached to a delivery catheter.Unable to review the final angiogram and cannot confirm that the leading end of catheter is broken, there is leading olive separation or that it remains inside of the patient.D12 - according to the gore® excluder® aaa endoprosthesis instructions for use (ifu), adverse events that may occur/or require intervention include but are not limited to leading end catheter component retention.

Event Description

It was reported to gore that a gore® excluder® iliac branch endoprosthesis (hgb161007) was used to treat a patient with abdominal aortic aneurysm and aneurysm in the right common iliac artery.It was additionally mentioned that this device was planned to be an extension of the previously successfully deployed gore® excluder® iliac branch endoprosthesis (hgb161207).The through-and-through wire was removed since a gore® dryseal flex introducer sheath (dsf1245) was needed inside of the hgb161207 to make sure that the hgb161007 catheter would not be too short when extending the previously deployed hypogastric component.The retrieval of the through wire was done with no issues due to the amplatz superstiff wire with 1 cm floppy tip inside and very distal in the hypogastric.The system remained completely stable.After device was deployed, the physicians started trying to retrieve the device catheter.Some resistance was felt and when the full catheter was out, it was realized that the proximal part/rod (including the proximal olive) was missing and stayed behind in the hypogastric branch.The physician tried to retrieve it with a snare but it was impossible and the piece stayed inside of the patient's artery.The patient is doing fine.

• 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: ida simson ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15587583
• MDR Text Key: 306655373
• Report Number: 3013164176-2022-01501
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P020004
• 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
• Report Date: 12/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: HGB161007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 76 YR
• Patient Sex: Male