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

Catalog Number CXT321414E

Device Problems Use of Device Problem (1670); Malposition of Device (2616); Activation Failure (3270); Migration (4003)

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

Event Date 03/22/2023

Event Type  malfunction  

Event Description

It was reported that on (b)(6) 2023, a patient was treated with a gore® excluder® conformable aaa endoprosthesis with active control system.Primary deployment via the white outer deployment knob was successful.Pulling out the white outer knob during secondary deployment activated the deployment mechanism as expected.Reportedly device imaging confirmed that the device deployed distally to its planned location.The physician suspected that too little pushing of the device by the assistant in the or and general mechanical forces may have cause this.The physician was able to reposition the graft just distal to the right renal artery using the constraining mechanism of the device.Then the red safety lock was pulled and the transparent knob was turned counter-clockwise and pulled.At this stage the device was unexpectedly constrained and pulled down a little distal to the right renal artery.The procedure was halted and the rest was done pulling the individual strings/fibers (2-5) utilizing backup deployment mechanism with no issues.Then an aortic extender was implanted to correct for positioning.It was reported that the final result was acceptable.The patient tolerated the procedure.

Manufacturer Narrative

A1: patient identifier remains unknown, therefore the gore reference number was used.H6-code b14: a review of the manufacturing records indicated the lot met all pre-release specifications.H6-code b15 and (b)(6): dicom imaging series were requested from the hospital.The requested could not be shared with gore, however, six screenshot were provided to gore for evaluation.The imaging evaluation summary states the following: ¿ six jpeg images were dated (b)(6) 2023.¿ no name on the imaging.¿ cannot confirm which and when deployment knobs were pulled.¿ jpeg image #1 (10:21am) shows a partially constrained proximal end of the device.¿ jpeg #2 (10:22am) shows the proximal end of the device is bunched.The device appears to remain on the delivery catheter.¿ jpeg #3 (10:22am) the proximal device is less bunched, however, there does not appear to be proximal device/wall apposition.¿ jpeg #4 (11:19am) the proximal end of the device does not appear to align perpendicular to the aortic flow lumen.There is an additional non-deployed device present.¿ jpeg #5 (11:46am) proximal device markers indicate an aortic extender has been added.¿ jpeg #6 (11:46am) implanted devices appear to be patent.No endoleaks are identified.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.

Manufacturer Narrative

Cause investigation and conclusion: a review of the manufacturing records indicated the lot met all pre-release specifications.Dicom imaging series were requested from the hospital.The requested could not be shared with gore, however, six screenshot were provided to gore for evaluation.The imaging evaluation summary states the following: six jpeg images submitted for evaluation dated 3/22/2023.No name on the imaging.Cannot confirm which and when deployment knobs were pulled.Jpeg image #1 (10:21am) shows a partially constrained proximal end of the device.Jpeg #2 (10:22am) shows the proximal device is partially constrained and remains on the delivery catheter.Jpeg #3 (10:22am) the proximal device appears to be more expanded, however, there does not appear to be proximal device/aortic wall apposition.Jpeg #4 (11:19am) the proximal end of the device does not appear to align perpendicular to the aortic flow lumen.There is an additional non-deployed device present.Jpeg #5 (11:46am) proximal device markers indicate an aortic extender has been added.Jpeg #6 (11:46am) implanted devices appear to be patent.No endoleaks are identified.The delivery system of the device was returned to gore.The evaluation summary states the following: two bends were found in the constraining loop wire, measuring 75 mm and 116 mm from the leading end of the clear constraining mechanism.There was no visible damage within the access hatch to indicate incorrect routing.There was no damage seen on the constraining loop and the constraining loop eyelet was intact and also appeared undamaged.A singular bend was observed in the lock pin at approximately the same location as the constraining loop wire (~96 mm).The lock pin hole appeared normal and intact.No other damage was observed on the lock pin or to the trailing end of the leading tip.Some damage was observed near the skive of the catheter.No other damage to the catheter was observed.Based on the findings from the evaluation, the physician¿s observation that ¿the procedure was halted and the rest was done pulling the individual strings/fibers (2-5) utilizing backup deployment mechanism¿ was confirmed due to the absence of the backup hatch cover with the returned components.The reported observation that ¿the device was unexpectedly constrained and pulled down a little distal to the right renal artery¿ was unable to be confirmed with the available information from this evaluation.Based on the event description and the subsequent investigation, no further information was provided to gore, therefore we are was unable to determine the cause for the deployment abnormality and assign a root cause.However, the physician reported to gore that he suspected that too little pushing of the device by the assistant in the or and general mechanical forces may have cause the device to deploy distally to its planned location.In the instructions for use the following is stated: gore® excluder® conformable delivery system - trunk ipsilateral endoprosthesis deployment loosen the white outer deployment knob by turning it 90° counter-clockwise (figure 9a).Confirm desired device position and orientation, stabilize the delivery catheter, and deploy the trunk using a steady and continuous pull of the deployment knob to release the proximal endoprosthesis past the contralateral leg hole of the trunk.Pull the deployment knob straight out from the catheter handle.Deployment initiates from the leading end toward the trailing end.The ipsilateral leg will remain constrained on the delivery catheter.If the trunk is not properly positioned following removal of the white outer deployment knob, continue with optional repositioning of trunk-ipsilateral leg endoprosthesis, described below.Warning: incorrect deployment or migration of the endoprosthesis may require surgical intervention.Caution: deployment of the trunk over a floppy (soft) section of a guidewire with the angulation wire in its most advanced position may cause the delivery catheter to bend excessively leading to distal movement of the trunk during deployment.

• 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: 16822284
• MDR Text Key: 314077651
• Report Number: 3007284313-2023-02465
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: NO
• 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
• Report Date: 08/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CXT321414E
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2022
• 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
• Treatment: GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS WIT
• Patient Age: 87 YR
• Patient Sex: Male