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

Catalog Number RLT261412

Device Problem Collapse (1099)

Patient Problems Intracranial Hemorrhage (1891); High Blood Pressure/ Hypertension (1908); Thrombosis/Thrombus (4440)

Event Date 03/15/2024

Event Type  Death  

Manufacturer Narrative

Additional devices included on this report are as follows: catalog #plc271200/ serial # (b)(6)/ udi # (b)(4).Catalog #plc271000/ serial # (b)(6)/ udi # (b)(4) as components of the same system.H.6.Type of investigation: code b15 - images were provided, and an imaging evaluation will be performed.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) 2023, the patient underwent endovascular treatment of bilateral iliac artery aneurysms using gore® excluder® aaa endoprostheses in the abdominal aorta.It was reported that, on an unknown date, one month follow-up ct imaging was performed and there were no reported issues.On march 15, 2024, it was reported that the patient presented to the emergency room with blood pressure in the 200s.The proximal portion of the trunk had reportedly collapsed and was thrombosed.The cause of the collapsed graft was unknown, and it was unknown whether the collapsed trunk had caused the high blood pressures or vice versa.On the same day the patient underwent emergent reintervention to explant the trunk-ipsilateral leg component and contralateral leg components.It was reported that there were no issues with the contralateral limbs or implanted gore® excluder® iliac branch endoprostheses (ibe).The ibe devices remained implanted.The procedure was completed.It was reported that, at some point during post-op day one, the patient expired from an intracranial bleed.It was unknown whether the collapsed graft and high blood pressures had caused/contributed to the intracranial bleed, but it was reported that causality could not be ruled out.

Event Description

On (b)(6) 2023, the patient underwent endovascular treatment of bilateral iliac artery aneurysms using gore® excluder® aaa endoprostheses in the abdominal aorta.It was reported that, on an unknown date, one month follow-up ct imaging was performed and there were no reported issues.On (b)(6) 2024, it was reported that the patient presented to the emergency room with blood pressure in the 200s.The proximal portion of the trunk had reportedly collapsed and was thrombosed.The cause of the collapsed graft was unknown, and it was unknown whether the collapsed trunk had caused the high blood pressures or vice versa.On the same day the patient underwent emergent reintervention to explant the trunk-ipsilateral leg component.It was reported that there were no issues with the contralateral limbs or implanted gore® excluder® iliac branch endoprostheses (ibe).A bifurcated surgical graft was sewn infrarenal and attached to the contralateral leg components bilaterally.The ibe devices remained implanted.The procedure was completed.It was reported that, at some point during post-op day one, the patient expired from a head bleed.It was unknown whether the collapsed graft and high blood pressures had caused/contributed to the head bleed, but it was reported that causality could not be ruled out.

Manufacturer Narrative

A.4.Patient weight: asked but unavailable.B.7.Other relevant history, including preexisting medical conditions: asked but unavailable.D.10.Concomitant medical products and therapy dates: asked but unavailable.H.6.Investigation findings for analysis of production records: code c19 - the review of the manufacturing paperwork verified that the lots involved in this event met all pre-release specifications.H.6.Type of investigation: code b15 added.H.6.Type of investigation: code b15 - the device was not returned for evaluation.An analysis of relevant data was performed in view of supporting the identification of possible causes of the event.H.6.Type of investigation for engineering evaluation: code c070601 - the device was not returned for evaluation.Evaluation of the clinical images appeared to show the proximal end of the endoprosthesis compressed which is consistent with the reported failure mode.However, an occlusion beyond the proximal end of the device could not be confirmed with the image provided.The root cause of the compressed and thrombosed endoprosthesis could not be established with the available information.H.6.Type of investigation for imaging evaluation: code c070601 - one jpeg image was provided for evaluation.No name, date, or demographics were present on the image.The axial image appeared to show the proximal end of the gore® excluder® aaa endoprosthesis was compressed.There did not appear to be flow within the visualized portion of the compressed device.Unable to confirm occlusion of devices beyond the level of the proximal device with the available image.H.6.Investigation conclusions: code d15 - there is insufficient information available for gore to reasonably draw conclusions related to aspects of the event, therefore conclusion code ¿d15: cause not established¿ is being used.Insufficient information may include limited or missing relevant medical records, involvement of multiple implanted devices (including non-gore devices) in the field of treatment, patient non-compliance, and/or a general lack of available detail or specificity related to an adverse event and/or device.H.6.Investigation conclusions: code d12 added.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), potential device or procedure related adverse events that may occur and/or require intervention or additional intraoperative procedure time include, but are not limited to, endoprosthesis occlusion, surgical cut down, bypass or conversion, neurologic damage (local or systemic), and death.

• 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: jenna lopez ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 19103032
• MDR Text Key: 340100169
• Report Number: 3007284313-2024-03173
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132622443
• UDI-Public: 00733132622443
• 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
• Report Date: 04/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RLT261412
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2024
• Date Device Manufactured: 08/08/2023
• 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; Death
• Patient Age: 60 YR
• Patient Sex: Male