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

Catalog Number CXT361414

Device Problems Material Separation (1562); Migration (4003)

Patient Problem Insufficient Information (4580)

Event Date 02/14/2022

Event Type  Injury  

Manufacturer Narrative

Additional devices included on this report are as follows: catalog #plc181200/ serial #(b)(6) / udi #(b)(4).Catalog #plc271000/ serial #(b)(6) / udi #(b)(4).A.4.Patient weight: asked but unavailable.B.7.Other relevant history, including preexisting medical conditions: asked but unavailable d.10.Concomitant medical products and therapy dates: asked but unavailable.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) 2022, the patient underwent endovascular treatment of an abdominal aortic aneurysm using gore® excluder® conformable aaa endoprostheses.A conformable trunk-ipsilateral leg component and two gore® excluder® aaa endoprosthesis contralateral leg components were implanted.On (b)(6) 2024, the physician informed the gore representative that approximately 3 of the anchors on the trunk-ipsilateral leg component had become disconnected from the proximal end of the device.The trunk had migrated distally approximately 3cm down into the aneurysm sac and the disconnected anchors reportedly remained lodged in the patient's aortic neck.Additionally, thrombus was observed in the distal limbs and in the patient's left renal artery.It is unknown if there was aneurysm enlargement present.The cause of the anchor disconnection and distal migration was reportedly unknown.There was no reported patient anatomy that was suspected to have caused or contributed to the event.On the same day, the device system was explanted.A left renal artery bypass was performed, a thrombectomy was performed in both iliac arteries, a dacron graft was surgically implanted, and a cut down was performed at the patient's left groin to resolve remaining thrombus.There were no further reported issues.The patient tolerated the procedure.

Manufacturer Narrative

B.3.Date of event: as device migration was first observed on imaging dated (b)(6) 2022, this date has been used as the estimated date of event.H.6.Investigation conclusions: code d16 remains unchanged b.3.Date of event updated.H.6.Health effect - clinical code e2401 updated to code e050102.

Manufacturer Narrative

D.9.Device returned to manufacturer and date of device return added h.6.Type of investigation: code b15 - images were provided, and an imaging evaluation was performed.H.6.Investigation findings for imaging evaluation: code c0701 - the imaging evaluation found that ct imaging dated (b)(6) 2022, showed the length from the lowest renal artery to the proximal end of device measured approximately 57 mm, ct imaging dated (b)(6) 2022, showed the length from the lowest renal artery to the proximal end of device measured approximately 63 mm, and ct imaging dated (b)(6) 2023, showed the length from the lowest renal artery to the proximal end of device measured approximately 102 mm.Aneurysmal max diameters increased from 72 mm x 83 mm in 2022 to 73 mm x 86 mm in 2023.On the ct dated november 18, 2023, thrombus was observed in the graft in the right common iliac artery.The thrombus was not visible on the ct¿s from 2022.On the 2023 ct, there were 7 anchors and 3 gold bands visible.The 3 gold bands were attached to the proximal end of the device while the anchors did not appear to be attached to the device.Images confirmed the device had migrated distally and the anchors had detached form the proximal end of the graft.H.6.Investigation conclusions: code d16 remains unchanged h.6.Investigation findings for analysis of information provided by user/third party: code c21 updated to code c0701.

Manufacturer Narrative

H.6.Investigation findings for testing of actual/suspected device: code c070603 - the specimens were returned for investigation.Submitted in formalin was a large quantity (> 500 ml) of brown, friable, fragmented tissue (consistent with aneurysmal sac thrombus) and a gore® excluder® conformable aaa endoprosthesis system consisting of the following: one trunk ¿ ipsilateral leg endoprosthesis fragment (tf-1) with a contralateral leg endoprosthesis fragment (clf-1) contained within the ipsilateral leg of the trunk, one trunk ¿ ipsilateral leg endoprosthesis fragment (tf-2) consisting of a fragment of the ipsilateral leg containing a contralateral leg endoprosthesis fragment (clf-2) within and extending distally, one contralateral leg endoprosthesis (cl), and three constraint sleeve fragments.The device fragments had been transected prior to arrival at w.L.Gore & associates.The abluminal surfaces of the device specimens were variably covered by a variably thick layer of friable brown, soft tissue.The luminal surfaces of all device specimens were covered in a variably thick layer of friable brown, soft tissue.The lumens of the device specimens were patent.Freely floating were innumerable, variably sized fragments of friable brown, soft tissue, which was grossly consistent with aneurysmal sac thrombus.One wire fragment was found amongst the free-floating tissue.The following findings were identified upon examination of the high-resolution radiographs: two wire discontinuity pairs were identified on the proximal stent row of the trunk fragment.In addition, two anchor fragments with three wire discontinuity faces, were present around the proximal region of trunk.One free floating tissue specimen, which was composed of fibrous connective tissue, had two wire fragments contained within.Histopathology was not performed, due to the lack of proper fixation, prior to arrival.The specimens were subjected to an enzymatic digestion process to remove biologic debris.Following digestion all specimens were examined for material disruptions with the aid of a stereomicroscope.On the ipsilateral leg of the trunk fragment, just proximal to the area where the trunk ipsilateral leg and contralateral leg fragment were overlapping, a partial displaced stent row with an associated area of disrupted bonding tape was present.The exact time and cause of the displaced stent row and associated are of disrupted bonding tape could not be determined with the information provided.Two wire discontinuity pairs were present on the proximal apices of the proximal stent row of the trunk.Two anchor fragments were attached on the abluminal surface of the trunk, around the proximal region.Anchor fragment 1 had two wire discontinuities present, each occurring in the region of the proximal apices.The other anchor fragment had one wire discontinuity present, which occurred in the region of the distal apices.The remaining end of anchor fragment was cut in a beveled manner, consistent with an anchor terminal wire end created during the manufacturing process.The free-floating wire fragment and two wire fragments contained within the tissue were consistent with fragments from anchor stent aspects.The fragments had one end each that was cut in a beveled manner, consistent with an anchor terminal wire end created during the manufacturing process.The other ends of the fragments had wire discontinuities present, which were not consistent with terminal wire ends created during the manufacturing process.The free-floating wire fragment faces were not able to be paired with a matching fragment face on the trunk fragment.It is evident that not all of the anchor aspects of the trunk were accounted for with the return.Representative wire specimens were collected and submitted for metallurgical analysis.The examined wire discontinuities exhibited topological characteristics that are indicative of fracture from fatigue loading.Microscopic examination of the nitinol wire fractures did not show evidence of corrosion or manufacturing irregularities.Additionally, an engineering evaluation was performed.The evaluation found that the explanted device had anchors detached or broken on the proximal end of the device.There was evidence of bonding tape at the location that the anchors were expected to attach to the graft.This indicates the anchors were appropriately attached to the graft during manufacturing.There was no evidence of incorrect taping or other processing of the endoprosthesis that could have contributed to the reported event.No manufacturing deficiencies were identified.Based on the findings from the evaluation, the cause of the reported event could not be attributed to the device manufacturing or design with the available information.H.6.Investigation conclusions: code d15 - there is insufficient information available for gore to reasonably draw conclusions related to aspects of the event, therefore conclusion code ¿d15: cause not established¿ is being used.Insufficient information may include limited or missing relevant medical records, involvement of multiple implanted devices (including non-gore devices) in the field of treatment, patient non-compliance, and/or a general lack of available detail or specificity related to an adverse event and/or device.H.6.Investigation conclusions: code d12 added according to the gore® excluder® aaa endoprosthesis instructions for use, potential device or procedure related adverse events that may occur and/or require intervention or additional intraoperative procedure time include, but are not limited to, component migration, stent fracture, aneurysm enlargement, and surgical cut down, bypass or conversion.H.6.Investigation findings for testing of actual/suspected device: code c21 updated to code c070603.H.6.Investigation conclusions: code d16 updated to code d15.

Manufacturer Narrative

H.6.Investigation conclusions: code d15 remains unchanged.H.6.Investigation conclusions: code d12 remains unchanged.H.6.Investigation conclusions: code d1001 added.According to the gore® excluder® conformable aaa endoprosthesis instructions for use, potential device or procedure related adverse events that may occur and/or require intervention or additional intraoperative procedure time include, but are not limited to, component migration, stent fracture, aneurysm enlargement, and surgical cut down, bypass or conversion.

• 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: jenna lopez ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18718502
• MDR Text Key: 335521689
• Report Number: 3007284313-2024-03051
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132651078
• UDI-Public: 00733132651078
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P200030
• 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,Followup,Followup,Followup
• Report Date: 06/14/2024

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: 07/12/2024
• Device Catalogue Number: CXT361414
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/18/2024
• Initial Date FDA Received: 02/16/2024
• Supplement Dates Manufacturer Received: 03/28/2024; 03/28/2024; 05/06/2024; 06/14/2024
• Supplement Dates FDA Received: 03/28/2024; 03/28/2024; 06/05/2024; 06/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2021
• 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): Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male