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

Catalog Number CXT281412E

Device Problems Break (1069); Material Separation (1562)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/02/2023

Event Type  Injury  

Manufacturer Narrative

Patient id is unknown.Manufacturer placeholder provided instead.Device evaluated by mfr: the device remains implanted.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 that on (b)(6) 2023, a patient was treated for abdominal aortic aneurysm with a gore® excluder® conformable aaa endoprosthesis.The endoprosthesis was successfully deployed.While retracting the deployment wire, the physician detected resistance and was unable to withdraw the catheter through the gore® dryseal flex introducer sheath.The tip tore off the end of the catheter and became lodged in the aneurysm sheath.An additional endoprosthesis was deployed to cover the iliac artery as it was not possible to remove the tip from the patient.

Manufacturer Narrative

A review of the manufacturing records indicated the lots met all pre-release manufacturing specifications.The device evaluation performed by engineering showed the following: the returned delivery system catheter had a broken inner lumen just leading to the transition bond.There was evidence of stretching of the inner lumen holes.This break location and evidence of inner member elongation is consistent with the catheter being pulled with force.Based on the findings from the evaluation, the condition of the returned device is consistent with the event description that ¿the tip tore off the end of the catheter¿ and ¿while retracting the deployment wire, the physician detected resistance¿.The reason for the catheter break cannot be confirmed with the available information.The physician¿s observation that ¿no stenosis or other anatomical restrictions that may have affected withdrawal of the olive were reported¿ could not be evaluated with the available information.No manufacturing deficiency was identified.With the information reported to gore this investigation is considered complete, the cause of the complaint was unable to be determined.

Event Description

It was reported that on january 2, 2023, a patient was treated for abdominal aortic aneurysm with a gore® excluder® conformable aaa endoprosthesis.The endoprosthesis was successfully deployed.While retracting the deployment wire, the physician detected resistance and was unable to withdraw the catheter through the gore® dryseal flex introducer sheath.The tip tore off the end of the catheter and became lodged in the aneurysm sheath.An additional endoprosthesis was deployed to cover the iliac artery as it was not possible to remove the tip from the patient.

• 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: tom hormby ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 16203731
• MDR Text Key: 307682517
• Report Number: 3007284313-2023-02307
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/22/2023

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: CXT281412E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/03/2023
• Initial Date FDA Received: 01/19/2023
• Supplement Dates Manufacturer Received: 08/22/2023
• Supplement Dates FDA Received: 08/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2022
• 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): Other