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

Catalog Number PLC271200J

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Shock (2072); Vascular Dissection (3160)

Event Date 09/08/2023

Event Type  Injury  

Manufacturer Narrative

H.6: code c19: a review of manufacturing records verified that the lot involved in this complaint met all pre-release specifications.H.6: code b20: device remains implanted and therefore not available for direct analysis.H.6: code a0101: the physician stated that the cause of the dissection may be the poor vessel status and large diameter of the left common iliac artery.H.6: code d12: 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 include, but are not limited to, endoleaks,dissection, perforation, or ruptures of the aortic vessel and surrounding vasculature.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), additional considerations for patient selection include but are not limited to: patient¿s anatomical suitability for endovascular repair.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, an angiography revealed a distal type i endoleak of a contralateral leg, plc271200j as a left leg.Additionally touch up using coda balloon was performed, however the proximal type i endoleak was not resolved.Plc271000j was additionally implanted within the left leg and a long touch-up using coda balloon was performed.The distal type i endoleak was resolved, however a retrograde dissection was observed in a left common iliac artery.It appeared to be leaking a little and appeared to be rupturing.A left internal iliac artery was coil embolized with coda balloon occlusion.Additionally plc121400j was implanted to extend to a left external iliac artery.An angiography revealed no endoleak and no contrast at the dissection site.The patient tolerated the procedure.The physician stated that the cause of the dissection may be the poor vessel status and large diameter of the left common iliac artery.Or the last touch-up may have caused the dissection.

• 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: kathryn irwin ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17872883
• MDR Text Key: 324961261
• Report Number: 3013164176-2023-01857
• 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
• Report Date: 10/04/2023

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: PLC271200J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/08/2023
• Initial Date FDA Received: 10/04/2023
• Date Device Manufactured: 05/02/2023
• 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): Other
• Patient Age: 77 YR
• Patient Sex: Male