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

Catalog Number CEB231210H

Device Problems Premature Activation (1484); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Aneurysm (1708)

Event Date 02/13/2023

Event Type  malfunction  

Event Description

On (b)(6) 2023, the patient underwent an endovascular procedure to treat an abdominal aortic aneurysm using a gore® excluder® iliac branch endoprosthesis (ceb).Reportedly, the device was properly prepared.It was reported that after the positioning in the desired site, the physician unscrewed the white outer deployment knob and pulled to deploy the first stage of the ceb but the device deployed fully.The physician didn't notice the gray inner deployment knob for the second stage (ipsi lateral to the external iliac) was attached/stuck in the white cap and both stages deployed at once.The physician was able to continue the procedure using a gore® molding and occlusion balloon catheter (mob) positioned in the ipsilateral site to avoid the movement of the ceb when doing manipulation from the contralateral side.The physician confirmed that no resistance or device breakage was felt.The procedure was completed as planned without any harm to the patient or complications.The patient tolerated the procedure.

Manufacturer Narrative

Code c19- a review of the manufacturing record for the device verified the lot met all pre-release specifications.The device remains implanted and is not available for analysis.However, the knobs will be provided for analysis.Further information will be provided.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 clinical specialist mentioned that by only watching it was noticed it was taking a bit longer.The physician confirmed that no resistance or device breakage was felt.

Manufacturer Narrative

H6: code c19- a review of the manufacturing record for the device verified the lot met all pre-release specifications.The device remains implanted and is not available for analysis.However, the knobs were provided for analysis.H6: code c16 - the deployment knobs were sent to gore for evaluation.Only the deployment knobs assembly with attached deployment lines were available.The second deployment knob was inside the first deployment knob.The luer lock where the deployment knobs are screwed in had separated from the catheter hub still attached to the first and second deployment knobs.There was no evidence of adhesive in the luer lock section where it is bonded to leading 2-arm of the catheter hub.Several pictures were provided from the field that showed the deployment knobs assembly had separated from the catheter hub.However, the pictures did not contain any additional information.The findings from the evaluation are consistent with the physician¿s observations.The cause for the luer lock separation from the catheter is a lack of bonding between the luer lock and leading 2-arm of the delivery catheter hub.The cause for the lack of bonding is the absence of adhesive.A definitive root cause for the absence of adhesive could not be identified.However, the capa request had been initiated to continue investigating this event and determine potential corrective actions.This type of occurrence will continue to be monitored.

• 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: nataliya baramzina ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 16464720
• MDR Text Key: 310989825
• Report Number: 3013164176-2023-01624
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: P020004
• 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: 04/13/2023

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: CEB231210H
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/13/2023
• Initial Date FDA Received: 03/01/2023
• Supplement Dates Manufacturer Received: 03/29/2023
• Supplement Dates FDA Received: 04/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2022
• 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 Age: 64 YR
• Patient Sex: Male
• Patient Ethnicity: Hispanic