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

Catalog Number PLA280300J

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Arrest (1762); Vascular Dissection (3160)

Event Date 08/04/2023

Event Type  Injury  

Manufacturer Narrative

H.6.Investigation findings code c19: the device remains implanted and is not available for analysis.A review of the manufacturing records for the device verified that the lot met all pre-release specifications.H.6.Investigation conclusions code d12: it should be noted that, per the gore® excluder® aaa endoprosthesis instructions for use, adverse events that may occur and / or require intervention or additional intraoperative procedure time include, but are not limited to: dissection.Additional gore® tag® device captured on this report: sn: (b)(6), udi: (b)(4), catalog: pla260300j.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

The following information was reported to gore: on (b)(6) 2021, this patient underwent an endovascular treatment for an abdominal aortic aneurysm using gore® excluder® aaa endoprosthesis and gore® excluder® iliac branch endoprosthesis (ibe).Gore® viabahn® vbx balloon expandable endoprosthesis (vbx) was also used as an internal iliac branch component.In total, 9 pieces of the devices were implanted (trunk-ipsilateral leg, two contralateral legs, iliac branch component (for the right side), internal iliac component, two vbxs and two aortic extenders).The patient tolerated the procedure.On (b)(6) 2023, reintervention was performed.To treat the left side type ib endoleak, the left internal iliac artery was coil-embolized and two additional contralateral leg components were implanted.The treatment area was extended into the external iliac artery and the endoleak disappeared.To treat the type ia endoleak, two additional aortic extender components were implanted but the endoleak remained.Thus, ballooning with gore® molding & occlusion balloon catheter was performed for the aortic extenders.After that no confirmation angiography was performed so the presence or absence of the type ia endoleak was unknown.After extubation, the patient developed cardiac arrest; therefore, cardiac massage was initiated and intubation was performed again.A ct scan showed an aortic dissection extending from the ascending aorta to thoracoabdominal area.It was reported that as the ct scan was non-contrast, the direction of the dissection was unknown.It was also unknown whether the dissection reached the treatment area.Considering the patient¿s advanced age, there was no plan for another procedure.The patient was hospitalized in a high care unit and her condition was unfavorable.

• 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 SILICON VALLEY B/P; 2890 de la cruz blvd.; santa clara CA 95050
• Manufacturer Contact: bryce wargin ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17671182
• MDR Text Key: 322516631
• Report Number: 3013164176-2023-01827
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 09/01/2023

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: PLA280300J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/04/2023
• Initial Date FDA Received: 09/01/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/14/2023
• 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): Life Threatening; Other; Hospitalization
• Patient Age: 87 YR
• Patient Sex: Female