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

Catalog Number RLT231412J

Device Problems Patient-Device Incompatibility (2682); Unintended Movement (3026); Insufficient Information (3190)

Patient Problem Rupture (2208)

Event Date 11/15/2023

Event Type  Injury  

Manufacturer Narrative

H.6.: code b22: results pending completion of investigation.H.6.: code c21: results pending completion of investigation.H.6.: d16: conclusion not yet available h.6.: code a26: results pending completion of investigation.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) 2023, a patient underwent endovascular treatment of an abdominal aortic aneurysm using gore® excluder® aaa endoprostheses.During the treatment, after all stent grafts were implanted, additional touch up for around a terminal aorta and a right common iliac artery using a coda balloon was performed because the patient's anatomy around the terminal aorta was narrow.While the additional touch up, a distal side of the right common iliac artery was ruptured.An extravasation to a retroperitoneum was confirmed.To treat it, occlusion was performed using a mob balloon and pll161407j was additionally implanted to the very edge of a branch of the right common iliac artery and an internal iliac artery, however the extravasation still remained.A right internal iliac artery was coil embolized.Then plc121400j was implanted to extend to a right external iliac artery.The extravasation was resolved.The patient tolerated the procedure.The physician stated that the balloon pressure was too strong.He was focused on the narrow part of the terminal aorta and applied excessive pressure.Instead of the coda balloon, a pta balloon should have been used.

Manufacturer Narrative

In corrected data: h.6.Investigation findings: code c21 updated to code c19.H.6.Type of investigation b22 updated to b13, and b14, and b20.H.6.Medical device problem code a26 updated to a0512.H.6.Investigation conclusions: code d16 updated to code d1001, d1102, and d12.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), physician and patient should review the risks and benefits when discussing this endovascular device and procedure, including possibility that subsequent interventional or open surgical repair of the aneurysm may be required after initial endovascular repair.Additional considerations for patient selection include but are not limited to: patient¿s anatomical suitability for endovascular repair.Per ifu, additional considerations for patient selection include but are not limited to: patient¿s anatomical suitability for endovascular repair.Ilio-femoral access vessel size and morphology (minimal thrombus, calcium and / or tortuosity) should be compatible with vascular access techniques.According to the gore® excluder® aaa endoprosthesis instructions for use, potential adverse events that may occur and or require intervention, include, but are not limited to: dissection, perforation, or ruptures of the aortic vessel and surrounding vasculature, bleeding, hematoma.

• 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: kathryn irwin ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18307311
• MDR Text Key: 330227568
• Report Number: 3007284313-2023-02936
• 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: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: RLT231412J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2022
• 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): Other
• Patient Age: 69 YR
• Patient Sex: Female