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

Catalog Number	PLC271000
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The following details were reported to gore: i had a dr.Do a case on an old excluder patient lost to follow up.The case and devices are in the images attached.The films are available on the cloud.My understanding is he presented to the emergency room with a rupture from a type 1b endo leak around the right limb.His weight was 121 kg.Past medical history, significant for peripheral artery disease, hypertension, hyper cholesterolemia, and coronary artery disease.Medication¿s are lipitor, 50 mg, lipitor, 20 mg, aspirin 325 mg.Proximal cuffs were placed to the level of the right renal despite evidence of leak.To fix the right iliac leak, the right internal iliac was coil embolized and a 121000 placed proximal, then 121200 distal in the rcia.Lastly, 161007 was placed across the coiled vessel, and extended into the reia.There was no leak seen on the left iliac side.She will see the patient and follow up and discuss options to treat the dilating left common iliac artery in the future.The physician attributed this issue to overall arterial dilation from progressing disease.
Additional Manufacturer Narrative
B7: past medical history, significant for peripheral artery disease, hypertension, hyper cholesterolemia, and coronary artery disease.D10: medication¿s are lipitor, 50 mg, lipitor, 20 mg, aspirin 325 mg.The imaging evaluation performed by a clinical imaging specialist showed the following: one time-point available for evaluation: post-implantation cta dated (b)(6) 2023.The length from the right renal artery to the proximal circumferential device appears to be 28.6mm, by centerline.There is extensive thrombus within this ~27mm of abdominal aorta.There is thrombus throughout the abdominal aorta.Aortic diameters in the proximal 15mm of abdominal aorta, distal to the right renal artery, appear to range from 29.1mm ¿ 39.3mm.There appears to be lack of proximal device apposition, however, there does not appear to be contrast outside the implanted device at these levels with available imaging.Axial images show unclear aortic borders.There are similar densities inside and outside the aorta at these levels.Findings are consistent with a ruptured aneurysm.There is contrast pooling in the posterior aneurysm sac, outside the implanted devices.The distal end of the device limb is in the abdominal aortic sac.There is lack of distal device apposition with contrast outside the device limb, thereby confirming a distal type i endoleak.Maximum diameters: abdominal aortic aneurysm ¿ 71.5mm x 74.5mm.Rci ¿ 35.3mm.Cannot confirm aneurysm growth with one time-point.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.

• Brand Name: GORE® EXCLUDER® AAA ENDOPROSTHESIS
• Common Device Name: 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 SUNNYVALE B/P; 1327 orleans drive; sunnyvale CA 94089
• Manufacturer Contact: laura crawford ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17922987
• Report Number: 2953161-2023-01190
• Device Sequence Number: 6794957
• Product Code: MIH
• UDI-Device Identifier: 00733132618538
• UDI-Public: 00733132618538
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/12/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2018
• Device Catalogue Number: PLC271000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2023
• Initial Report FDA Received Date: 10/12/2023
• Date Device Manufactured: 04/01/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 121 KG