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

Catalog Number CXA280005E

Device Problems Unintended Movement (3026); Migration (4003)

Event Date 06/19/2023

Event Type  Injury  

Manufacturer Narrative

D10 concomitant medical products: gore® excluder® iliac branch endoprosthesis, gore® excluder® aaa endoprosthesis requests were emailed to the physician to further clarify the event and to provide patient information.The provided information is captured in sections a and b.A review of the manufacturing records indicated the lot met pre-release specifications.H6-b20 and h3-other: neither images enabling direct assessment of product performance nor the product itself, which remains implanted, were returned for evaluation.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

It was reported to gore, that the patient presented with an aortic abdominal aneurysm has been treated with a gore® excluder® aaa endoprosthesis and a gore® excluder® iliac branch endoprosthesis (ibe).Reportedly anatomy was tortuous, but a good diameter was given, no calcification reported.It was stated that when deploying the contralateral leg endoprosthesis (plc271200) as bridging stent over a stiff wire and landed as intended, good overlap was achieved both proximally and distally.Reportedly during final ballooning it was apparent that the distal end of the limb wanted to pull up.After the stiff wires were taken out for the final run, the anatomy relaxed to it¿s original position and the limb moved 10-15 mm further out of the ibe main body.Because there was still a small overlap, it was decided to cover it with an gore® excluder® aaa endoprosthesis (aortic cuff cxa2800005e).At the end of the procedure a small leak was present at the end of the procedure, but it was decided to not perform any immediate actions.It was stated that on a routine ct scan a few days later on (b)(6) 2023 a large endoleak appeared.It showed the plc271400 and cxa280005e have both pulled out of the ibe main body completely (approximately 25 mm in total), causing a large type iii endoleak.On (b)(6) 2023 the endoleak was fixed by placing a iliac extender endoprosthesis (pll161407) followed by a contralateral leg endoprosthesis (plc271400) to again cover from evar main body to ibe main body.Reportedly the final run shows good overlap and no endoleak.Another scan will be performed in 1 month.

Event Description

It was reported to gore that, on (b)(6), 2023, the patient presented with an aortic abdominal aneurysm has been treated with gore® excluder® aaa endoprostheses and two gore® excluder® iliac branch endoprostheses (ceb231010 devices).Reportedly the anatomy was tortuous, but a good diameter was given, no calcification was reported.Stiff guide wires were used during the procedure.It was stated that the gore® excluder® aaa endoprosthesis contralateral leg endoprosthesis (plc271200 device), used as the bridging stent between the aortic main body and the left ceb231010 device, landed as intended and good overlap was achieved both, proximally and distally.Reportedly, the distal end of the plc271200 device tended to pull up during final ballooning.After the stiff guide wires were taken out for final imaging, the anatomy relaxed to its original position and the plc271200 device moved an additional 10 to 15 mm out of the ceb231010 device.Because there was still a small overlap of the devices, they religned the overlap region with a gore® excluder® conformable aaa endoprosthesis with active control system aortic extender endoprosthesis (cxa280005e device).Reportedly a small endoleak was present at the end of the procedure.It was reported that remedial action was not considered necessary.It was stated that, on (b)(6) 2023, follow up computed tomographic imaging showed a large type 3 endoleak as the plc271200 device and the cxa280005e device had completely slipped out of the ceb231010 device, totaling approximately 25 mm.On (b)(6) 2023, relining with a gore® excluder® iliac branch endoprosthesis iliac extender endoprosthesis (pll161407) and a gore® excluder® aaa endoprostheses contralateral leg endoprosthesis (plc271200) was performed to resolve the type 3 endoleak.Reportedly, final imaging showed good overlap, with no evidence of an endoleak.On august 14, 2023, it was reported to gore that no aneurysms growth occurred to date.

Manufacturer Narrative

Cause investigation and conclusion: equests were emailed to the physician to further clarify the event and to provide patient information.The provided information is captured in sections a through e.A review of the manufacturing records indicated the lot met pre-release specifications.Neither images enabling direct assessment of product performance nor the product itself, which remains implanted, were returned for evaluation.Therefore the cause of the reported migration leading to a type 3 endoleak could not be independently confirmed during the investigation.Based on the incident description and the subsequent investigation, no further information was provided to gore, we are unable to determine the cause of this incident and assign a root cause.The reported device migration resulting in a type 3 endoleak represents a known complication or adverse event that can occur when using stent-graft endovascular devices and can arise as a result of a multitude of factors, including intraprocedural technical considerations, patient-related risk factors and disease progression.It was reported to gore that the anatomy was tortuous.The tortuousness was modified, e.G.Straightened, during the procedure using stiff guide wires.Reportedly, the distal end of the plc271200 device already tended to pull up during final ballooning, and after removal of the stiff guide wires the anatomy relaxed to its original tortuousness resulting in plc271200 device movement of an additional 10 to 15 mm out of the ceb231010 device.Although was fixed with a cxa280005e device a small endoleak was present at the end of the procedure.Five days later, on (b)(6) 2023, a large type 3 endoleak was reported requiring reintervention.The available information reasonably suggests that the pre-existing patient condition (tortuous vessel anatomy) has caused of contributed to the disconnection of the implanted devices.According to the instructions for use (ifu), adverse events that may occur and / or require intervention include but are not limited to: endoleak, component migration; g3/g4: pma/510(k)number: updated with p200030.

Manufacturer Narrative

Further review of this incident revealed a causal relationship between the small endoleak discovered on (b)(6) 2023, reported with gore reference numbers (b)(4), and the large endoleak discovered on (b)(6) 2023, reported with gore reference numbers (b)(4).Therefore, the event date for (b)(4) has been updated to (b)(6) 2023, in this follow-up report.

Manufacturer Narrative

B3: updated date of event and event date for final closure as further review of this incident revealed a causal relationship between the small endoleak discovered on (b)(6) 2023, reported with gore reference numbers (b)(4), and the large endoleak discovered on (b)(6) 2023, reported with gore reference numbers (b)(4).Therefore, the event date for (b)(4) has been updated to (b)(6) 2023, in this follow-up report.The report on (b)(4) is considered a duplicate of this report and was therefore closed as a non-reportable incident.

Event Description

It was reported to gore that, on (b)(6) 2023, the patient presented with an aortic abdominal aneurysm has been treated with gore® excluder® aaa endoprostheses and two gore® excluder® iliac branch endoprostheses (ceb231010 devices).Reportedly the anatomy was tortuous, but a good diameter was given, no calcification was reported.Stiff guide wires were used during the procedure.It was stated that the gore® excluder® aaa endoprosthesis contralateral leg endoprosthesis (plc271200 device), used as the bridging stent between the aortic main body and the left ceb231010 device, landed as intended and good overlap was achieved both, proximally and distally.Reportedly, the distal end of the plc271200 device tended to pull up during final ballooning.After the stiff guide wires were taken out for final imaging, the anatomy relaxed to its original position and the plc271200 device moved an additional 10 to 15 mm out of the ceb231010 device.Because there was still a small overlap of the devices, they religned the overlap region with a gore® excluder® conformable aaa endoprosthesis with active control system aortic extender endoprosthesis (cxa280005e device).Reportedly a small endoleak was present at the end of the procedure.It was reported that remedial action was not considered necessary.It was stated that, on (b)(6) 2023, follow up computed tomographic imaging showed a large type 3 endoleak as the plc271200 device and the cxa280005e device had completely slipped out of the ceb231010 device, totaling approximately 25 mm.On (b)(6) 2023, relining with a gore® excluder® iliac branch endoprosthesis iliac extender endoprosthesis (pll161407) and a gore® excluder® aaa endoprostheses contralateral leg endoprosthesis (plc271200) was performed to resolve the type 3 endoleak.Reportedly, final imaging showed good overlap, with no evidence of an endoleak.On august 14, 2023, it was reported to gore that no aneurysms growth occurred to date.

• 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: 17631184
• MDR Text Key: 322045752
• Report Number: 3007284313-2023-02724
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P200030
• 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,Followup,Followup,Followup
• Report Date: 02/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CXA280005E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2022
• 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; Hospitalization
• Patient Age: 64 YR
• Patient Sex: Male