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

Model Number HGB161207A

Device Problems Collapse (1099); Obstruction of Flow (2423); Device Stenosis (4066)

Patient Problems Failure of Implant (1924); Thrombosis/Thrombus (4440)

Event Date 11/18/2022

Event Type  Injury  

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

On (b)(6) 2022, the patient was treated for an aorto-iliac aneurysm and was implanted with gore® excluder® aaa endoprosthesis and with bilateral gore® excluder® iliac branch endoprostheses.As reported, the patient was also implanted with gore® viabahn® vbx balloon expandable endoprostheses and there was no complaint or identified adverse event related to theses devices.As reported, on (b)(6) 2022, the gore field sales associate was notified by the physician that computed tomography (ct) showed that the gore® excluder® aaa endoprosthesis, trunk ipsilateral leg component appeared to have collapsed and was thrombosed.As reported, the patient was admitted for lysis of the gore® excluder® aaa endoprosthesis, trunk ipsilateral leg component.As reported, the graft was successfully opened back up.As reported, the right hypogastric was confirmed as open.As reported, the previously implanted stent in the left hypogastric is not open, but the limb itself is open.As reported, the patient is scheduled for a reintervention on (b)(6) 2022, in order to add a stent proximally to the gore® excluder® aaa endoprosthesis, trunk ipsilateral leg component as well as a non-gore metal graft.

Manufacturer Narrative

D10: as gore was unable to determine which device(s) caused or contributed to the event if any; additional device(s) implanted related to this event include the following, as investigated under mpdcase00011531-3: brand: gore® excluder® iliac branch endoprosthesis; product name: stent graft internal iliac component; catalog number: hgb161007a; lot/sn: (b)(6); udi: (b)(4).

Manufacturer Narrative

H6: added code e0514 under health effect - clinical code.H6: added code f11 under health effect - impact code.H6: added code a0106 under medical device problem code.H6: added code g04122 under component code.H6: updated code d16 with d15 under investigation conclusions.H6: updated code c21 with c19 under investigation findings.A review of manufacturing records verified that the lot involved in this complaint met all pre-release specifications.The imaging evaluation performed by a clinical imaging specialist showed the following: two jpgs submitted for evaluation.Images received via (email) with no patient identifier or date of acquisition in image.Unable to confirm the report of thrombus with the available images.According to the gore® excluder® iliac branch endoprosthesis instructions for use, adverse events that may occur and / or require intervention or additional intraoperative procedure time include, but are not limited to occlusion.

Manufacturer Narrative

H6: an updated imaging evaluation is as provided and the conclusion code remains unchanged.The imaging evaluation performed by a clinical imaging specialist showed the following: two jpgs submitted for evaluation.Images received via (email) with no patient identifier or date of acquisition in image.Dicom images submitted at a later date.Length from the right lowest renal to the proximal end of the compressed graft measures 9.7 mm.Diameter at the lowest renal measures 21.3 mm.The device did not maintain its intended expanded diameter post implantation.The proximal end of the device is compressed.The report of device compression is consistent with the observed crescent-shaped appearance of the device along the lateral arterial wall.The right side of the implanted device is occluded for a length of 30.7 cm on centerline reconstruction.The left side of the implanted device is occluded for a length of 28.6 cm on centerline reconstruction.The devices implanted in the internal iliacs are occluded bilaterally.This is consistent with the reported collapse and thrombosed of the device.Images on pages 11-13 show a non-contrast phase on the left, arterial phase in the center, delay phase on the right.The are patent lumbars present, patent ima and contrast outside of the implanted device on the arterial and delay phases.There is a type ii endoleak present.

Manufacturer Narrative

H6: added investigation conclusion code d12, d15 remains unchanged.

• 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: breanna cox ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15911087
• MDR Text Key: 304782752
• Report Number: 3013164176-2022-01560
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132635320
• UDI-Public: 00733132635320
• 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,Followup,Followup,Followup
• Report Date: 03/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: HGB161207A
• Device Catalogue Number: HGB161207A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2022
• 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
• Treatment: SEE H10/H11
• Patient Outcome(s): Other
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 191 KG