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

Device Problem Device Dislodged or Dislocated (2923)

Event Date 02/22/2024

Event Type  Injury  

Manufacturer Narrative

H6: b22 and c20 ¿ product history review could not be performed as the serial# is not available.H6: code c20 - the device remains implanted and, therefore, was not available for direct analysis by gore.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.Patient images were provided.Imagining analysis provided the following: reconstruction image shows device disconnection, thereby, confirming the type iii endoleak.The distal end of the contralateral leg used as the ibe bridging device has no wall apposition within the proximal ibe in the lci.The length from the distal end of the contralateral leg, within the abdominal aneurysm sac, to the proximal end of the ibe appears to be ~6cm, by outer curve length.The diameter at the distal end of the contralateral leg is 23.0mm.The diameters within the ibe trunk, in the lci, range from 23.0mm ¿ 24.3mm.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) 2020, patient underwent an endovascular procedure to treat an aorto-iliac aneurysm utilizing the gore® excluder® aaa endoprosthesis and gore® excluder® iliac branch endoprosthesis.On (b)(6) 2024, fsa was notified that the contralateral component migrated (6.5 cm) proximally from the original position, disconnecting from the gore® excluder® iliac branch endoprosthesis (iliac branch component), causing a type 3 endoleak.Reintervention surgery is scheduled for (b)(6) 2024.Physician does not know what caused this issue.It was also reported hospital did not send initial device implant information to gore, further patient information and serial# remains unknown.The cause of this endoleak/migration remains unknown.

Manufacturer Narrative

Fsa later reported reintervention surgery was performed on (b)(6) 2024.Two contralateral components were implanted to extend into the ibe device.

Event Description

Fsa later reported reintervention surgery was performed on (b)(6) 2024.Two contralateral components were implanted to extend into the ibe device.

• 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: 18942719
• MDR Text Key: 338148304
• Report Number: 3007284313-2024-03120
• 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: 04/19/2024

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/22/2024
• Initial Date FDA Received: 03/20/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/19/2024
• 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): Required Intervention