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

Device Problems Patient-Device Incompatibility (2682); Device Dislodged or Dislocated (2923)

Event Date 12/13/2023

Event Type  Injury  

Event Description

On an unknown date, patient underwent an endovascular procedure utilizing gore® excluder® aaa endoprosthesis and ibe.On 12/13/2023, physician called the fsa reporting imaging scans were reviewed for this patient which showed a distal type 1 endoleak that will need reintervention surgery.Fsa reports physician will have an appointment with the patient at a later time to discuss the reintervention surgical plan.The patient will undergo reintervention on an unknown date.There were no further reported issues.Physician believes this endoleak is a result of disease progression.No further patient information or lot/serial# is available.

Manufacturer Narrative

H6: b22 and c20 -attempt was made to obtain the device lot/serial number, and the lot/serial number was unavailable.Product history review could not be performed as the serial# is not available.H6: code b20 ¿ the device remains implanted and, therefore, was not available for direct analysis by gore.H6: code b15-images were provided and and imaging evaluation was performed.The imaging evaluation showed lack of distal ibe iliac branch apposition in the left external iliac artery.Contrast is visualized outside the implanted ibe iliac branch device, thereby, confirming a distal type i endoleak in the left external iliac artery.There are 2 devices implanted in the left internal iliac artery.Probable vbx devices (instead of internal iliac components) because of lack of radiopaque markers on the devices.There is ~27mm of device overlap between these 2 devices.There is lack of apposition of the distal end of the distal device implanted in the liia.It should be noted that, per 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.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 2/1/2024, fsa called and reported the following: patient underwent endovascular reintervention today(b)(6) with dr.(b)(6).They extended the device in the left iliac into the left external iliac using a plc161000 to treat the disease progression and endoleak.The patient tolerated the procedure.

Manufacturer Narrative

On 2/1/2024, fsa called and reported the following: patient underwent endovascular reintervention today (b)(6) with dr.B)(6).They extended the device in the left iliac into the left external iliac using a plc161000 to treat the disease progression and endoleak.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 PHOENIX 2 B/P; 32470 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: lillian espinoza ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18476572
• MDR Text Key: 332450755
• Report Number: 3007284313-2024-02992
• Device Sequence Number: 1
• Product Code: MIH
• 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: 02/01/2024

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/18/2023
• Initial Date FDA Received: 01/09/2024
• Supplement Dates Manufacturer Received: 02/01/2024
• Supplement Dates FDA Received: 02/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 80 YR
• Patient Sex: Female