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

Model Number RLT231412

Device Problems Collapse (1099); Device Stenosis (4066)

Patient Problems Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)

Event Date 11/18/2022

Event Type  Injury  

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

Other relevant history: the following information was requested but was not made available -patient medications and comorbidities.Code b13, communication/interviews: additional information in regard to the event of the case was requested.The provided additional information is captured in the event description.Code b15, analysis of data provided by user/third party: imaging was provided from the treating facility for consideration.Code b20, device not accessible for testing: the medical device remains implanted and was therefore not available for return and evaluation.Code c21, results pending completion of investigation: manufacturing and imaging evaluation results will be provided once they are completed.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.

Manufacturer Narrative

H6: c19, a review of the manufacturing records indicated the lots met all pre-release manufacturing specifications.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), potential adverse events that may occur and/or require intervention include, but are not limited to occlusion of device or native vessel, and reoperation.Imaging 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 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.Engineering evaluation summary this evaluation is based on the event description as reported to gore and images including an imaging evaluation.The device was not returned evaluation.The imaging evaluation concluded that the proximal end of the device had compressed.· the findings from this evaluation, are consistent with the physician¿s observation that the ¿trunk ipsilateral leg component appeared to have collapsed and was thrombosed¿.· the likely cause for the collapse could not be determined with the available information.

• Brand Name: GORE® EXCLUDER® AAA 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: breanna cox ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15910631
• MDR Text Key: 304783388
• Report Number: 3007284313-2022-02246
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132622368
• UDI-Public: 00733132622368
• 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: 03/06/2023

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?: Yes
• Device Operator: Health Professional
• Device Model Number: RLT231412
• Device Catalogue Number: RLT231412
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/18/2022
• Initial Date FDA Received: 12/02/2022
• Supplement Dates Manufacturer Received: 03/03/2023
• Supplement Dates FDA Received: 03/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2022
• 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
• Patient Outcome(s): Life Threatening; Required Intervention; Other
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 191 KG