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

Catalog Number CEB231210

Device Problems Fracture (1260); Material Separation (1562); Physical Resistance/Sticking (4012)

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

Event Date 03/27/2023

Event Type  malfunction  

Manufacturer Narrative

B13: requests were sent to the physician to further clarify the event.B14: a review of the manufacturing records indicated the lot met pre-release specifications.B01: the delivery system was returned with a guidewire inserted completely through the catheter.The evaluation summary states the following: the catheter transition bond between the outer shaft and polyimide guidewire lumen is broken.The catheter outer shaft shows the frayed wire and torn material at the break.The inner catheter shaft and polyimide guidewire lumen remain attached at the transition bond.In the evaluation, the guidewire would not move through the catheter, but would move the sections of the catheter outer shaft over the gap of the inner shaft.The cause of the resistance felt during the advancement of the device over the guidewire could not be determined with the currently available information.The cause of the break in the catheter outer shaft could not be determined with the currently available information.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 to gore that the patient presented with an iliac artery aneurysm was supposed to be treated with a gore® excluder® iliac branch endoprosthesis (ceb231210).It was stated that when the physician wanted to advance the device over the lunderquist® guidewire from cook medical, resistance was felt.The guidewire was changed to another lunderquist® guidewire and the device has been implanted successfully.No consequences for the patient were reported.

Manufacturer Narrative

A1: no patient specific details have been provided.Therefore, the patient initials reflect the w.L.Gore internal case number.Emdr section h6 codes updated to reflect results of investigation.Section h6: code d12-the gore® excluder® iliac branch endoprosthesis instructions for use (ifu) states: do not continue advancing any portion of the delivery system if resistance is felt during advancement of the guidewire, sheath, or catheter.Stop and assess the cause of resistance.Vessel or catheter damage or premature deployment have occurred and may result in potential patient harms.

Manufacturer Narrative

Section g: corrected address for "contact office - manufacturing site".

• Brand Name: GORE® EXCLUDER® ILIAC BRANCH 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 SILICON VALLEY B/P; 2890 de la cruz blvd.; santa clara CA 95050
• Manufacturer Contact: samir kulovic ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18157941
• MDR Text Key: 328362376
• Report Number: 3007284313-2023-02893
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P020004
• 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
• Report Date: 01/03/2024

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: CEB231210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/04/2023
• Initial Date FDA Received: 11/17/2023
• Supplement Dates Manufacturer Received: 09/04/2023; 03/28/2023
• Supplement Dates FDA Received: 12/21/2023; 01/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/03/2023
• 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
• Treatment: LUNDERQUIST® GUIDEWIRE (COOK MEDICAL)
• Patient Outcome(s): Hospitalization
• Patient Age: 81 YR
• Patient Sex: Male