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

Catalog Number CXT281412

Device Problem Difficult to Open or Close (2921)

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

Event Date 04/03/2024

Event Type  malfunction  

Manufacturer Narrative

H6: code c19 - a review of the manufacturing records indicated the lot met all pre-release specifications.H6: code b20 -the device remains implanted and was therefore not available for engineering evaluation by gore imaging evaluation summary: the images received cannot be used to perform a full imaging evaluation because they do not meet the dicom standard.The extent and accuracy of the observations and findings may be limited due to the completeness, format and/or quality of the images provided for review.Gore cannot guarantee the images provided are complete, accurate or lack alteration.Therefore, gore cannot guarantee all key findings have been captured or that the findings are accurate.The imaging evaluation performed by a clinical imaging specialist showed the following: ¿ nine jpgs submitted for evaluation.Images on pages 2-6 are of suboptimal quality.Images on pages 7 -9 show the contralateral gate on the patients left side appears to be kinked/pinched.What appears to be the final angiogram (page 10) illustrates a graft that is patent bilaterally with no visible contrast-like density outside of the graft.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

The following was reported to gore: on (b)(6) 2024, the patient underwent an endovascular procedure in infrarenal to treat an abdominal aortic aneurysm utilizing a gore® excluder® conformable aaa endoprosthesis (trunk ipsilateral conformable) and two gore® excluder® aaa endoprosthesis (contralateral legs).Reportedly, during the initial deployment of the trunk ipsilateral conformable, the trunk ipsilateral side deployed fine but the contralateral gate (on the patient's left side) was completely pinched at the flow divider (proximal end).The blood flow remained at 100% while it was pinched on the contralateral gate.Physician noted that there were no deployment issues at the initial stage but they could not access the contralateral gate as the flow divider was pinched.Physician tried to reconstrain and rotate the device few times in hopes of getting access again but it had no effect to open it back up.Device was deployed to full but contralateral gate side was still pinched at flow divider.After full deployment, physician ballooned the entire device but that still had no impact and unable to get access from below, so physician then had to come up and over with the wire to snare and was unable to snare as well.However, with a buddy wire up through via that up and over wire, they were finally able to get access then got the wire and sheath up without further issues.After this, the two contralateral legs were fully deployed and extended on the trunk ipsilateral conformable with perfect result.The pinched contralateral gate side was opened up and looked good.There were no anatomical issues and the procedure ended successfully.

Manufacturer Narrative

Engineering evaluation summary: the evaluation of the clinical images appears to show the contralateral gate on the patients left side kinked/pinched which is consistent with the reported failure mode.The root cause of the kink/pinched contralateral gate could not be established with the available information.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.".

• 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: jaskaran parhar ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 19209375
• MDR Text Key: 341377279
• Report Number: 3007284313-2024-03201
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132651054
• UDI-Public: 00733132651054
• 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
• Report Date: 05/09/2024

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 Catalogue Number: CXT281412
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/03/2024
• Initial Date FDA Received: 04/29/2024
• Supplement Dates Manufacturer Received: 05/08/2024
• Supplement Dates FDA Received: 05/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2023
• 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): Other
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 147 KG