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

Catalog Number PLC181000J

Device Problems Use of Device Problem (1670); Appropriate Term/Code Not Available (3191)

Patient Problem Aneurysm (1708)

Event Date 09/14/2023

Event Type  Injury  

Event Description

On september 14, 2023, the patient underwent an endovascular treatment.Gore® excluder® aaa endoprostheses were implanted for an abdominal aortic aneurysm.Reportedly, a coil embolization was performed on the left internal iliac artery prior to the procedure.During the procedure, the distal type i endoleak was confirmed on the landing zone on the right common iliac artery.As a treatment, an unplanned coil embolization on the right internal iliac artery was performed, and an additional device was placed in the right external iliac artery.The distal type i endoleak was resolved.The final angiography confirmed a type ii endoleak which was left to be monitored.The patient tolerated the procedure.According to the physician, it was concerned preoperatively that the distal landing on the right common iliac artery would be difficult because the right common iliac artery was short in length and calcified.A distal type i endoleak was anticipated, therefore, the left internal iliac artery was coil embolized preoperatively to develop collateral circulation in case the unplanned extension of stent graft to right external iliac artery and embolization for the right internal iliac artery were required during the procedure.

Manufacturer Narrative

Code c19: a review of the manufacturing records for the devices verified that the lot met all pre-release specifications.The device remains implanted and is not available for analysis.Code a27 was used to cover ¿it was concerned preoperatively that the distal landing on the right common iliac artery would be difficult¿¿ 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 endoleak.Per ifu, additional considerations for patient selection include but are not limited to patient¿s anatomical suitability for endovascular repair.Additionally, ilio-femoral access vessel size and morphology (minimal thrombus, calcium and / or tortuosity) should be compatible with vascular techniques.Key anatomic elements that may affect successful exclusion of the aneurysm include significant thrombus and / or calcium at the arterial implantation sites, specifically the proximal aortic neck and distal iliac artery interface.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.

Manufacturer Narrative

H6: 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.The physician believed that the short right common iliac artery with calcification contributed to the distal type i endoleak.The length of the right common iliac artery was 21mm, which is outside of ifu range.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 endoleak.Per ifu, additional considerations for patient selection include but are not limited to patient¿s anatomical suitability for endovascular repair.The ifu requires the distal segment iliac vessel lengths of at least 30mm.Additionally, ilio-femoral access vessel size and morphology (minimal thrombus, calcium and/or tortuosity) should be compatible with vascular techniques.Key anatomic elements that may affect successful exclusion of the aneurysm include significant thrombus and/or calcium at the arterial implantation sites, specifically the proximal aortic neck and distal iliac artery interface.

Event Description

On (b)(6) 2023, the patient underwent an endovascular treatment using gore® excluder® aaa endoprostheses for an abdominal aortic aneurysm.Reportedly, a coil embolization was performed on the left internal iliac artery prior to the procedure.During the procedure, the distal type i endoleak was confirmed on the landing zone on the right common iliac artery.Reportedly, the length of the right common iliac artery was 21mm, which was outside of ifu range.As a treatment, an unplanned coil embolization on the right internal iliac artery was performed, and an additional device was placed in the right external iliac artery.The distal type i endoleak was resolved.The final angiography confirmed a type ii endoleak which was left to be monitored.The origin of the type ii endoleak is unknown.The patient tolerated the procedure.According to the physician, it was concerned preoperatively that the distal landing on the right common iliac artery would be difficult because the right common iliac artery was short in length and calcified.The physician believed that the short right common iliac artery with calcification contributed to the distal type i endoleak.A distal type i endoleak was anticipated, therefore, the left internal iliac artery was coil embolized preoperatively to develop collateral circulation in case the unplanned extension of stent graft to right external iliac artery and embolization for the right internal iliac artery were required during the procedure.

• 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: nataliya baramzina ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17848791
• MDR Text Key: 324658248
• Report Number: 3013164176-2023-01847
• 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,Followup
• Report Date: 10/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: PLC181000J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2023
• 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; Hospitalization; Required Intervention
• Patient Age: 83 YR
• Patient Sex: Male