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

Catalog Number CXT361414E

Device Problems Fracture (1260); Device Slipped (1584)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/16/2022

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: gore® excluder® aaa endoprosthesis catalog plc181000 , (b)(4).Gore® excluder® aaa endoprosthesis catalog plc121400 , (b)(4).(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

On (b)(6) 2020, the patient underwent an endovascular aortic repair for an abdominal aneurysm that was treated with a gore® excluder® conformable aaa endoprosthesis (cxt361414e device) and two gore® excluder® aaa endoprostheses (plc181000 device and plc121400 device).Reportedly the neck of the aneurysm was kinked.No difficulties were encountered during the procedure.Follow up computed tomography imaging dated (b)(6) 2022, showed that the cxt361414e device has moved distally more than 30 mm.Reportedly neither an endoleak nor aneurysmal sac growth were noticed.The physician reported that he suspects that too much thrombus was the cause of the cxt361414e device movement.It was reported that the patient is asymptomatic and is doing fine.However, an endovascular reintervention is required to elongate the cxt device proximally using further devices.The physicians are currently evaluating possible solutions.Reportedly the reintervention will be performed soon.

Manufacturer Narrative

H6-code 4112: additional imaging series have been shared with gore by the physician for evaluation.In the imaging evaluation summary the following is stated: pre-implant images dated (b)(6) 2020 demonstrates significant thrombus within the aortic neck.The aortic diameters where the device was implanted later on measured 29 - 30 mm.Intra-procedural images dated (b)(6) 2026 show that the device was deployed well below the renal artery and just proximal to the aneurysm.There is as much as 8 mm of thrombus within this implantation site.The aortic diameters in the area implanted are 27-28 mm (average) or 28-30 (maximum).Follow up images dated (b)(6) 2020 show that the device appears to be 18 mm distal to the lowest renal artery.Follow up images dated (b)(6) 21 show that the device is now located a few millimeters distal to its initial implantation site.It is 26 mm distal to the lowest renal artery.There is one anchor visible showing slightly above the device.Follow up images dated (b)(6) 2022 show that the device is now 47 mm distal to the lowest renal artery.There are now 2 anchors showing proximal to the device.

Manufacturer Narrative

B1: added "serious injury" h1: the type of reportable event was updated to "serious injury" based on additional information indicating that a reintervention was required because of the product malfunction.

Event Description

On (b)(6) 2020, the patient underwent an endovascular aortic repair for an abdominal aneurysm that was treated with a gore® excluder® conformable aaa endoprosthesis (cxt361414e device) and two gore® excluder® aaa endoprostheses (plc181000 device and plc121400 device).Reportedly the neck of the aneurysm was kinked.No difficulties were encountered during the procedure.Follow up computed tomography imaging dated (b)(6) 2022, showed that the cxt361414e device has moved distally more than 30 mm.Reportedly neither an endoleak nor aneurysmal sac growth were noticed.The physician reported that he suspects that too much thrombus was the cause of the cxt361414e device movement.It was reported that the patient is asymptomatic and is doing fine.However, an endovascular reintervention is required to elongate the cxt device proximally using further devices.On (b)(6) 2022, a reintervention was performed to extend the migrated endoprosthesis with two endurant¿ stent grafts (medtronic).On (b)(6) 2022, follow up control imaging showed that there is no endoleak.Reportedly, the patient is fine.

Manufacturer Narrative

Description of the evaluation concerning possible root causes/causative factors and conclusion: a review of the manufacturing records indicated the lot met all pre-release specifications.The physician provided imaging series of five timepoints for evaluation: pre-implantation cta ( (b)(6) 2020), intra-operative angiogram ( (b)(6) 2020), and post-implantation ctas ( (b)(6) 2020, (b)(6) 2021, and (b)(6) 2022).The imaging evaluation summary states the following: (b)(6) 2020: pre-implant ct demonstrates significant thrombus within the aortic neck.(b)(6) 10:09 the device appears to be deployed well below the renal artery and just proximal to the aneurysm.(b)(6) 2020 10:45:49 final ballooning confirms the device initial implantation.Based on the previous image, it seems likely that the diameters in the area implanted are 27 mm -28 mm (average) or 28 mm -30 mm (maximum).There is as much as 8 mm of thrombus within this implantation site.(b)(6) 2020 aortic diameters where the device was implanted 29 mm - 30 mm.(b)(6) 2020 the device appears to be 18 mm distal to the lowest renal artery.The device was not deployed at the renal artery.(b)(6) 2021 the device is a few mm distal to its initial implantation site.It is 26 mm distal to the lowest renal artery.The device was not deployed at the renal artery.There is one anchor visible showing slightly above the device.(b)(6) 2022 the device is now 47 mm distal to the lowest renal artery.There are now 2 anchors showing proximal to the device.The device was not deployed at the renal artery.The device remains implanted therefore an evaluation of the actual device could not be performed.An evaluation was performed based on the event description and the images provided.The engineering evaluation summary states the following: observations from the imaging evaluation are consistent with distal movement.The imaging evaluation determined that the average aortic diameters measured to be 27 mm - 28 mm (average) or 28 mm - 30 mm (maximum) in the area implanted.A 36 mm device was used in this procedure, which per the instructions for use (ifu) is intended for use in 30 mm - 32 mm aortic necks.It is not clear if the use of a device oversized to the intended sizing window per the ifu contributed to the post-operation trunk migration.Imaging determined that the device photos depicted 2 anchors that were separated from and proximal to the device, indicating anchor fractures.While provided information and images demonstrated that device anchors separated and the device migrated distally, based on the photos provided and imaging evaluation conclusions, engineering was not able to identify any product deficiencies that may have led to these events.A review of manufacturing records and risk documentation did not yield a root cause for the reported event based on the photos provided.Based on the imaging evaluation conclusions, the evaluated distal movement of the device is consistent with the physician¿s description that ¿the cxt361414e device has moved distally more than 30 mm¿.Also, it is not clear when the observed anchor fractures confirmed by imaging occurred, and if the fractures contributed to the distal movement of the device.The imaging evaluation confirmed significant thrombus in the aortic neck, and the device ifu states: "key anatomic elements that may affect successful exclusion of the aneurysm include severe proximal neck angulation (> 60°), short proximal aortic neck (<15 mm), and significant thrombus and / or calcium at the arterial implantation sites, specifically the proximal aortic neck and distal iliac artery interface.Significant thrombus may be quantified as thrombus = 2 mm in thickness and / or = 25 % of the vessel circumference in the intended seal zone of the aortic neck.Irregular calcium and / or plaque may compromise the fixation and sealing of the implantation sites".However, engineering is unable to confirm if the observed thrombus is the true root cause of the event and is therefore unable to confirm the reported observation that ¿the physician reported that he suspects that too much thrombus was the cause of the cxt361414e device movement¿.Additionally, with the available information, engineering is unable to determine if the device size selection, which was outside the ifu indicated size window, contributed to the device¿s post-operation trunk migration.No manufacturing deficiencies could be identified.Replaced fda codes with imdrf codes.

• Brand Name: GORE® EXCLUDER® CONFORMABLE 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: sibylle staerk ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 14718332
• MDR Text Key: 294906657
• Report Number: 3007284313-2022-01972
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P200030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/15/2022

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
• Device Expiration Date: 11/24/2022
• Device Catalogue Number: CXT361414E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/23/2022
• Initial Date FDA Received: 06/16/2022
• Supplement Dates Manufacturer Received: 07/19/2022; 10/21/2022; 08/27/2022
• Supplement Dates FDA Received: 07/21/2022; 10/22/2022; 11/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/25/2019
• 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
• Treatment: (B)(6).
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 84 YR
• Patient Sex: Male