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

Catalog Number CXT321414E

Device Problem Difficult to Open or Close (2921)

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

Event Date 08/01/2022

Event Type  malfunction  

Event Description

Fda reported: "difficulty with angulation in seal zone.Graft opening towards us (anterior) despite anatomical angulation ant-post.On initial entry of device (constrained) pulling back on glidewire advantage did little to device angulation movement, angulation control also resulted in little movement.Slow initial deployment showed two markers at the level of the renal artery however the third was separating significantly (pulling down?) difficult to get steep cranial angulation due to intubation tubes.Could not get the graft to open orthogonally." on (b)(6) 2022, the patient was treated for an thoracic aortic anuerysm.While implanting a gore® excluder® conformable aaa endoprosthesis, the physician experienced difficulty in getting the graft to conform to the curve of the artery.The graft had been inserted on the right side over a glidewire advantage guidewire, and positioned for angio imaging.After moving the c-arm to the appropriate position, the wire was pulled back to see how the graft would sit in the artery, and there was almost no change.Angulation was attempted using the control handle, with a similar lack of success.The wire was running on the inside curve, and the surgeon advised that there was no chance of getting the wire to the outer curve.Deployment was started, (approximately 1cm), and the physician began to see one proximal marker dramatically separate distally on the fluoro screen away from the two other markers.The physician attempted to take parallax out as much as possible, but was restricted by tubing.The graft was reconstrained and moved higher to readjust and pulled back into position to try angulation and unconstrain the graft.It appeared that the angulation exacerbated the issue that was being seen, as though the graft was opening towards the imager, but in an oval shape.A number of other maneuvers were attempted after the initial repositioning, including trying to rotate the graft while constrained adn out of the sheath completely.However, none of the maneuvers were successful.During the adjustments, the graft moved down, and the physician was able to advance again, but the final position was low.The graft was deployed.The patient will be planned for a fenestrated cuff.The physician believes that the graft opening may have caught on something that pulled down on one side, or got caught in the pocket that was seen in the neck.He also mention that in hindsight, orienting the device so that the contra gate was on the inner curve may have potentially helped.A review of images by the fsa after the procedure led the fsa to believe there may be a previously-missed dissection in the seal.Discussion with the physician the following day questioned that idea, as the physician felt it may have been an imaging artifact rather than a dissections.Images were returned for evaluation.

Manufacturer Narrative

(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.

• 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: greg rawlings ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15303342
• MDR Text Key: 305505013
• Report Number: 3007284313-2022-02089
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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
• Report Date: 08/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/11/2022
• Device Catalogue Number: CXT321414E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/01/2022
• Initial Date FDA Received: 08/26/2022
• Date Device Manufactured: 11/12/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 71 YR
• Patient Sex: Male