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

Catalog Number	PLC201000
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Rupture (2208); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H.6.Code c19: a review of the manufacturing records for the device verified that the lot met all pre-release specifications.The device remains implanted and is not available for analysis.It was reported that the case was completed with patient stable condition.Pre-implant imaging evaluation was sent to gore imaging for analysis.The investigation is in process.Further information will be provided.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 or Problem Description
On january 11, 2024, the patient underwent endovascular procedure using gore® excluder® aaa endoprostheses to treat an abdominal aortic aneurysm.Reportedly, at the end of the procedure, the patient¿s right common iliac artery was ruptured as doctor was ballooning the plc201000/27561267 by the coda® balloon at the end of the procedure.A coda® balloon catheter (cook incorporated, bloomington, in) was also advanced on left side to occlude aorta while advanced a plc121000 over the ruptured iliac to achieve the seal in the external artery and occluding the internal iliac.The case was completed with patient stable condition.It was reported that the physician possibly over inflated the device.Reportedly, the mid iliac vessel was on ifu and measured at 18.5mm, the distal iliac was smaller at 14mm-15mm.The plc201000/27561267 was not damaged.
Additional Manufacturer Narrative
B6: imaging evaluation was updated.H.6.Code c19: a review of the manufacturing records for the device verified that the lot met all pre-release specifications.The device remains implanted and is not available for analysis.Code a26 was used to cover that the additional images were requested but are not available.Code c20 was used to cover that imaging was unable to provide an evaluation in relationship to this event.E2402 was used to cover that the procedure was completed with no harm to the patient.It was reported that the case was completed with patient stable condition.Code d1102 covered-it was reported that the physician possibly over inflated the device with the coda® balloon.Reportedly, the mid iliac vessel was on ifu and measured at 18.5mm, the distal iliac was smaller at 14mm-15mm.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), adverse events that may occur and / or require intervention or additional intraoperative procedure time include but are not limited to vascular trauma (e.G., ilio-femoral vessel dissection, bleeding, rupture).Additional considerations for patient selection include but are not limited to: patient¿s anatomical suitability for endovascular repair.Per contralateral leg endoprosthesis sizing guide for the (b)(4) ¿ the intended iliac vessel diameter is 16.5-18.5mm, however, it was reported that the distal iliac was smaller at 14mm-15mm.Per ifu, ilio-femoral access vessel size and morphology should be compatible with vascular access techniques.Additionally, per ifu: monitor balloon volumes and pressures as recommended in balloon catheter instructions for use.Follow the manufacturer¿s recommended method for size selection, preparation, and use of aortic and iliac dilation balloons.Carefully inflate the balloon to avoid complications.

• 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 SILICON VALLEY B/P; 2890 de la cruz blvd.; santa clara CA 95050
• Manufacturer Contact: nataliya baramzina ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18577146
• Report Number: 3013164176-2024-01966
• Device Sequence Number: 9080326
• Product Code: MIH
• UDI-Device Identifier: 00733132618590
• UDI-Public: 00733132618590
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2024

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: 09/27/2026
• Device Catalogue Number: PLC201000
• 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: 01/12/2024
• Supplement Date Received by Manufacturer: 01/31/2024
• Initial Report FDA Received Date: 01/24/2024
• Supplement Report FDA Received Date: 02/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2023
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention
• Patient Sex: Male