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

Device Problems Complete Blockage (1094); Patient-Device Incompatibility (2682); Device-Device Incompatibility (2919); Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Aneurysm (1708); Hematoma (1884); Hypovolemic Shock (1917); Perforation of Vessels (2135); Hypovolemia (2243); Vascular Dissection (3160); Thrombosis/Thrombus (4440)

Event Date 03/10/2023

Event Type  Injury  

Event Description

The following article was reviewed: zuidema, r., bastianon, m., jm, m.V., mozzetta, g., vries, j.P., schuurmann, r.C.And pratesi, g., 2023.Single-center results of the gore excluder conformable endoprosthesis with active control system in endovascular aneurysm repair.The journal of cardiovascular surgery.The article is a single center study of 46 patients presenting with either abdominal aortic aneurysms or aortoiliac aneurysms between november 2018 and january 2022.The patients were treated with gore® excluder® conformable aaa endoprosthesis with active control systems.Thirty-one presenting with aortoiliac aneurysms with common iliac artery diameters of >18 mm were also treated with gore® excluder® iliac branch endoprostheses.Follow-up with ct imaging continued between 19-30 months following implantation.Follow-up concluded in 2022.One patient presented with thrombosis of the external iliac artery ipsilateral from the iliac branch device.The patient was treated with thrombectomy and a common femoral artery ¿ profunda femoral artery bypass.One patient was treated with implantation of an additional iliac branch device following iliac aneurysm enlargement of an unknown amount at 3 months.The patient subsequently presented emergently with hypovolemic shock due to retroperitoneal hematoma caused by a ruptured external iliac artery ipsilateral of the iliac branch device.The patient was treated with relining and drainage of the hematoma.One patient presented with a type iii endoleak at the connection between the contralateral leg and iliac branch device.The patient was treated with relining (see also type iii endoleak reported with (b)(4)).One presented with external iliac artery rupture at 7-18 months after implantation and was treated with relining of the iliac branch device.The patient also presented with a type ii endoleak throughout the follow-up period (see patient 1 reported with (b)(4)).

Manufacturer Narrative

A1: no specific patient details have been provided.Therefore the gore reference number was used as the patient identifier.A2: the median age of the patients in the article was stated to be 78 years.A3: the vast majority of patients were male.B3: the date the events occurred remain unknown.Therefore the date the literature was first published was used as the date of event.H6-b13: a request was emailed to the corresponding author to provide device and patient information.H6-b15: the following article was reviewed: zuidema, r., bastianon, m., jm, m.V., mozzetta, g., vries, j.P., schuurmann, r.C.And pratesi, g., 2023.Single-center results of the gore excluder conformable endoprosthesis with active control system in endovascular aneurysm repair.The journal of cardiovascular surgery.H6-b20 nad h3-other: the devices remain implanted.Therefore a device evaluation could not be performed.Within the reviewed literature several events have been reported: serious injuries (reported with gore reference number (b)(4)), and device malfunctions (reported with gore reference number (b)(4)).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 article was reviewed: zuidema, r., bastianon, m., jm, m.V., mozzetta, g., vries, j.P., schuurmann, r.C.And pratesi, g., 2023.Single-center results of the gore excluder conformable endoprosthesis with active control system in endovascular aneurysm repair.The journal of cardiovascular surgery.The article is a single center study of 46 patients presenting with either abdominal aortic aneurysms or aortoiliac aneurysms between november 2018 and january 2022.The patients were treated with gore® excluder® conformable aaa endoprosthesis with active control systems.Thirty-one presenting with aortoiliac aneurysms with common iliac artery diameters of >18 mm were also treated with gore® excluder® iliac branch endoprostheses.Follow-up with ct imaging continued between 19-30 months following implantation.Follow-up concluded in 2022.One patient presented with thrombosis of the external iliac artery ipsilateral from the iliac branch device.The patient was treated with thrombectomy and a common femoral artery ¿ profunda femoral artery bypass.One patient was treated with implantation of an additional iliac branch device following iliac aneurysm enlargement of an unknown amount at 3 months.The patient subsequently presented emergently with hypovolemic shock due to retroperitoneal hematoma caused by a ruptured external iliac artery ipsilateral of the iliac branch device.The patient was treated with relining and drainage of the hematoma.One patient presented with a type iii endoleak at the connection between the contralateral leg and iliac branch device.The patient was treated with relining.One presented with external iliac artery rupture at 7-18 months after implantation and was treated with relining of the iliac branch device.The patient also presented with a type ii endoleak throughout the follow-up period.

Manufacturer Narrative

The incidents were reported within a literature article.Several attempts were made to obtain additional information to the reported incidents, patient information and device information from the corresponding author.The requests remained unanswered.Unique device identification numbers were not provided, therefore the manufacturing dates and/or production details cannot be determined.Neither images enabling direct assessment of product performance nor the products itself, which remain implanted, were returned for evaluation.Based on the review of the literature and the subsequent investigation, no further information was provided to gore, therefore we are unable to determine the cause of the reported incidents and assign a root cause.The dates of the incidents remained unknown.Therefore the data range of the study including the study follow up was used.As a best estimate (b)(6) 2022 was selected for the conclusion date.The patient gender reflects the vast majority of the patient cohort given in the literature.The patient age reflects the mean age of patients given in the literature.In the instructions for use the following is stated: potential device or procedure related adverse events adverse events that may occur and / or require intervention or additional procedure time include, but are not limited to: aneurysm enlargement, aneurysm rupture, arterial or venous thrombosis, bleeding, hematoma, dissection, perforation, or rupture of the aortic vessel and surrounding vasculature, endoleak, endoprosthesis or delivery system: component migration, occlusion of device or native vessel.

• Brand Name: GORE® EXCLUDER® ILIAC BRANCH 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: sibylle staerk ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17258517
• MDR Text Key: 318454045
• Report Number: 3007284313-2023-02595
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/11/2023

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/07/2023
• Initial Date FDA Received: 07/05/2023
• Supplement Dates Manufacturer Received: 10/11/2023
• Supplement Dates FDA Received: 10/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male