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

Catalog Number CXT201412E

Device Problems Break (1069); Obstruction of Flow (2423); Patient-Device Incompatibility (2682); Unintended Movement (3026)

Patient Problems Obstruction/Occlusion (2422); Foreign Body In Patient (2687)

Event Date 09/20/2021

Event Type  Injury  

Manufacturer Narrative

The delivery system of the device and x-ray images have been requested from the physician for evaluation.The release by the hospital is still pending.A review of the manufacturing records indicated the lot met all pre-release specifications.

Event Description

The patient presented with an aortic aneurysm that was treated with a gore® excluder® conformable aaa endoprosthesis (cxt201412e device).It was reported, that after releasing the cxt201412e device from the right side of the patient and cannulating the controlateral gate, the physician brought the gore® dryseal flex introducer sheath (dsf1233) inside the gate and released the ipsilateral leg of the cxt201412e device.At this point, he attempted to withdraw the delivery catheter of the cxt201412e device without success.He then inflated an aortic balloon passing from the left side to simultaneously retract the delivery catheter.He tried it several times without success.Eventually the tip of the delivery catheter has broken.The delivery catheter was withdrawn but the tip remained inside the cxt201412e device.After this angiography control showed that the cxt201412e device has moved distally a few centimeters below the lowest renal artery (the left one).He then implanted a gore® excluder® conformable aaa endoprosthesis (cxa200005e aortic extender endoprosthesis) and a gore® excluder® aaa endoprosthesis (pla230300 aortic extender endoprosthesis) to cover the distance from the proximal end of the cxt201412e device to the left renal artery.After post-dilating the devices with a balloon the tip of the delivery catheter of the cxt201412e device was secured between the devices.A further angiography control showed that the left femoral iliac axis has a good flow, but not on the right axis, where the ipsilateral leg of the cxt201412e device appears occluded within the right common iliac.Endovascular attempts to re-open the ipsilateral leg were unsuccessful.The physician then closed the right axis with a vascular plug and performed a femoral-femoral bypass.At follow-up angiography control, flow was restored to both sides.The patient has left the operating room in good condition.

Manufacturer Narrative

H6-code 213: the delivery system of the device was returned for investigation.The engineering evaluation summary states the following: the quad lumen inner member component of the returned delivery system catheter had broken at the inner lumen, proximal to the torque bump.This break location is consistent with the catheter being pulled with force while the leading tip was held in place until the catheter broke which is consistent with the physician¿s observation that ¿he then inflated an aortic balloon passing from the left side to simultaneously retract the delivery catheter.He tried it several times without success.Eventually the tip of the delivery catheter has broken.¿.Damage was noted to both torque bumps, which were seen to have delamination, although both were still adhered to the catheter and had not fully detached.It is unclear if the damage to the torque bumps was caused by the excessive manipulation of the device mentioned in the event description or at another point during or after the procedure.It was observed that a bond was present between the inner lumen and torque bump assembly, which is expected to be seen at the location of the catheter break and indicates a sufficient bond between the two subassemblies at the transition bond.Reported movement and occlusion of the cxt201412e device could not be confirmed with the available information.Therefore, no product deficiencies could be identified to relate to these failure modes.The gore® excluder® conformable aaa endoprosthesis instruction for use states: ¿do not continue to withdraw the delivery catheter if resistance is felt during removal through the introducer sheath¿, and ¿if resistance is felt during removal of delivery catheter through the introducer sheath, stop and withdraw delivery catheter and introducer sheath together¿.

Manufacturer Narrative

B4 - updated description: h6-code 4112 and 213: radiographic images were disclosed to w.L.Gore & associates for investigation.The imaging evaluation summary states the following: the main body is seen moving distally during the procedure after a balloon was used distally.Because the aorta contains a reverse taper, this would not be a device failure but a procedural/physician choice.The procedure/physician choice leads to the use of 2 aortic extenders and there is likely a type 1 or type 3 endoleak.There are no cine runs which document that the endoleak was resolved.The gate was initially deployed in the ipsi sheath.There appeared to be attempts to manipulate the delivery catheter without evidence of constraining the device or deploying the ipsi limb.There are no pre-case images to ascertain the aortic diameters and angulation to better understand why the gate appeared irregular prior to cannulation.However, as mentioned it was initially deployed partly within the ipsi sheath.The images seem to indicate some manipulation of the device while it is unconstrained and the ipsi limb undeployed.The olive tip is seen above the graft with an inflated balloon shows an inflated balloon in the main body and the olive tip is within the graft slightly above the flow divider where it remains for the duration of the procedure.Run 325, 11:32 shows the olive tip free of the wire and catheter.Regarding occlusion: flow was demonstrated within the l contra limb but not noticed on the right.There are no details regarding using syringes to pull back and encourage blood flow into the legs during this angiogram.Other angiograms, noted that the r common iliac was patent when retrograde injections were completed.

Event Description

The patient presented with an aortic aneurysm that was treated with a gore® excluder® conformable aaa endoprosthesis (cxt201412e device).It was reported, that after releasing the cxt201412e device from the right side of the patient and cannulating the controlateral gate, the physician brought the gore® dryseal flex introducer sheath (dsf1233) inside the gate and released the ipsilateral leg of the cxt201412e device.At this point, he attempted to withdraw the delivery catheter of the cxt201412e device without success.He then inflated an aortic balloon passing from the left side to simultaneously retract the delivery catheter.He tried it several times without success.Eventually the tip of the delivery catheter has broken.The delivery catheter was withdrawn but the tip remained inside the cxt201412e device.After this angiography control showed that the cxt201412e device has moved distally a few centimeters below the lowest renal artery (the left one).He then implanted a gore® excluder® conformable aaa endoprosthesis (cxa200005e aortic extender endoprosthesis) and a gore® excluder® aaa endoprosthesis (pla230300 aortic extender endoprosthesis) to cover the distance from the proximal end of the cxt201412e device to the left renal artery.After post-dilating the devices with a balloon the tip of the delivery catheter of the cxt201412e device was secured between the devices and remains inside the patient.A further angiography control showed that the left femoral iliac axis has a good flow, but not on the right axis, where the ipsilateral leg of the cxt201412e device appears occluded within the right common iliac.Endovascular attempts to re-open the ipsilateral leg were unsuccessful.The physician then closed the right axis with a vascular plug and performed a femoral-femoral bypass.At follow-up angiography control, flow was restored to both sides.The patient has left the operating room in good condition.

Manufacturer Narrative

Investigation conclusion: based on the event description and the subsequent investigation, a use error was identified as the most likely root cause of the reported break of the delivery catheter.The main body is seen moving distally during the procedure after a balloon was used distally.Because the aorta contains a reverse taper, this would not be a device failure but a procedural/physician choice.Evaluation of the provided images showed that the aorta contained a reverse taper which is procedural/physician choice.The reverse taper is most likely the root cause for the movement of the device.Therefore, the movement is not considered to be a failure mode of the device in the present case.Because of the movement of the device due to the procedure/ physician choice to use a reverse taper the use of two aortic extenders was needed.Evaluation of the provided images showed that there is likely a type 1 endoleak which is a known inherent risk of the device.Usually most of these types of endoleak resolve themselves over time after the procedure because blood dynamics and anatomy changes/adapts to the device.The gore® excluder® conformable aaa endoprosthesis instructions for use (ifu) mentions the following: - do not continue to withdraw the delivery catheter if resistance is felt during removal through the introducer sheath¿, and ¿if resistance is felt during removal of delivery catheter through the introducer sheath, stop and withdraw delivery catheter and introducer sheath together.- adverse events that may occur and / or require intervention or additional intraoperative procedure time include, but are not limited to: endoprosthesis component migration; occlusion; endoleaks.

Manufacturer Narrative

H6: code 4112, investigation findings and conclusion: radiographic images of the case were requested from the user to be shared with gore for evaluation.Images were received and an evaluation was performed.The following was observed: run 89 at 9:49am shows that the contralateral gate appears to be on the left side.Run 94 at 9:50am shows that the main body appears to be repositioned with the long marker (contralateral gate) on the patient¿s right side.There appears to be a narrowing of the device at the position just proximal to the long marker.This could be consistent with over-rotation of the device catheter.Cine run 108 at 9:54am appears to indicate more force being applied to the delivery catheter.Run 117 & 119: proximal ballooning demonstrated.The olive tip is visualized at the level of the device bifurcation.Run 239 at 10:54am shows a cuff is attempted to be delivered.There appears to be proximal movement of the contralateral gate while advancing the aortic extender through the gate.Run 162 at 10:20am shows that there appears to be a type 1 endoleak.There is flow within the l common iliac but not noticed on the right.Run 287 at 11:10am shows that no contrast appears to be moving distally into the r iliac artery.There still appears to be a type 1 endoleak.The images do not indicate that the olive tip is irregular or is coming in contact with the proximal portion of the stent graft in a way that would lead to difficulty removing the catheter.Based on the event description and the subsequent investigation, we are unable to determine the exact cause of this incident and assign a root cause with complete assurance.As the most probable root cause of the reported break of the delivery catheter a use error was identified: one the observations could be consistent with over-rotation of the device catheter.There appears to be a narrowing of the device at the position just proximal to the long marker where over-rotation was observed.Attempting to remove the catheter after over-rotation might have led to the reported break of the delivery catheter.The reported occlusion of the right common iliac artery may be associated with either the narrowing of the device during over-rotation, or separation of the delivery catheter tip.

Manufacturer Narrative

H6: code 4112 and conclusion (more clear language).Based on the event description and the subsequent investigation, we are unable to determine the exact cause of this incident and assign a root cause with complete assurance.As the most probable root cause of the reported break of the delivery catheter a use error was identified: per the imaging evaluation there was visual evidence of narrowing of the ipsilateral device lumen consistent with over rotation of the device.There was also visual evidence of excessive device rotation directly as the contralateral marker can be seen progressing from an initial rotational position to a final rotational position.These rotations occur prior to the indication from the physician that the catheter was difficult to remove and are consistent with the visual evidence of narrowing.Attempting to remove the catheter after over-rotation might have led to the reported break of the delivery catheter.The reported occlusion of the right common iliac artery may be associated with either the narrowing of the device during over-rotation, or separation of the delivery catheter tip.

• 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: 12840992
• MDR Text Key: 284468869
• Report Number: 3007284313-2021-01664
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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,Followup
• Report Date: 08/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/07/2022
• Device Catalogue Number: CXT201412E
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2019
• 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: CXA20000005E / PLA230300 / PLC141000
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 84 YR
• Patient Sex: Male
• Patient Weight: 72 KG