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

Catalog Number CXT231412E

Device Problems Break (1069); Material Fragmentation (1261); Difficult to Remove (1528)

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

Event Date 02/01/2024

Event Type  malfunction  

Manufacturer Narrative

As part of our routine quality procedures, each batch of devices undergoes comprehensive quality control testing and inspections prior to release for distribution.Gore reviewed the manufacturing records associated with the reported lot number and verified that all release criteria had been met.The following investigations are planned: a review of patient imaging, engineering evaluation of the delivery system (currently in transit).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 a gore® excluder® conformable aaa endoprosthesis was used for an endovascular aneurysm repair (evar) together with a 15 fr gore® dryseal flex introducer sheath.Some resistance was experienced while advancing the device through the sheath, however, after adjusting the fill in the sheath valve the device went through, although reportedly "more snug than usual".No issues were experienced during deployment and the device was implanted in the planned location.The physician experienced some resistance upon withdrawing the device delivery catheter back through the 15fr sheath (resistance was felt as the olive approached the sheath).It appeared on the screen that the olive was catching on the edge of the sheath due to a bend in the anatomy.It was reported that there was a significant 90 degree turn in the patient's proximal common iliac artery, and some calcium was present.The physician kept the olive just above the end of the sheath and brought the catheter and sheath back together by a few centimeters until reaching a straighter section of vessel.After this, the physician re-advanced and retracted the delivery catheter a few times and the device catheter eventually came out through the sheath.After exiting the patient, damage was observed on both devices.The gore® dryseal flex introducer sheath had a ragged edge.The device catheter has what appears to be a gouge in the shaft distal to the olive.No evidence of broken plastic pieces from the device were observed anywhere (neither in patient nor on the operation table).The patient has not suffered any damage to our knowledge and no further actions are planned.It was reported that nothing unusual about the devices were observed prior to insertion into patient.However, it remains unclear if this damage on the devices was already present or if it occurred due to the manipulation of the devices.

Manufacturer Narrative

D10: in addition, the device history record was reviewed for the gore® dryseal flex introducer sheath to ensure that each manufacturing and inspection operation was performed and indicated the product met creganna medical specifications and procedures.Imaging evaluation stated the following: the images provided for evaluation are pre-implant images.The bilateral common iliacs and external iliacs are tortuous and have calcium.Gore is unable to confirm if the tortuosity and/or calcium of the iliacs may have contributed to the event.Based on the incident description and the subsequent investigation, no further information was provided to gore, we are unable to determine the cause of this incident and assign a root cause.D9, and h3 other code: multiple attempts have been made to acquire the devices back for evaluation.The location of the devices are unknown, therefore, no engineering investigation could be performed.H6: update a0401 to a040103.Remove b01.Update c21 to c19.Update d16 to d1001, d15, and d12.

Manufacturer Narrative

Multiple attempts have been made to acquire the devices back for evaluation.The location of the devices are unknown, therefore, no engineering investigation could be performed.Therefore, section h6: remove b01, replace with b17.Engineering evaluation of the provided photo stated the following: the reported damage observed on the leading end of the catheter could not be independently confirmed.The image provided in the email shows a catheter that was manufactured according to the standard operating procedures and no damage is able to be observed.The physician¿s observation of a ¿gouge in the shaft distal to the olive¿ was determined to be the skive cut, which is intentional and part of the regular manufacturing process.The skive allows the constraining loop and lock mandrel to exit the catheter on the leading end of the catheter just distal to the leading olive.The reported device failure of ¿difficult to insert¿ into the introducer sheath could not be independently confirmed.The device was not returned so no evaluation of fit into a sheath could be evaluated.The physician also reported difficulty withdrawing the catheter through the sheath, which was not able to be independently confirmed due to the device not being returned.The root cause of the reported failure could not be established with the information provided.Per the gore® excluder® conformable aaa endoprosthesis instructions for use (ifu), adverse events that may occur and/or require intervention or additional intraoperative procedure time include, but are not limited to: delivery catheter: damage, failure, difficulty / unable to remove.Warnings and precautions also state the following: key anatomic elements that may affect successful exclusion of the aneurysm include severe proximal neck angulation (> 60°), short proximal aortic neck (<15 mm), and significant thrombus and / or calcium at the arterial implantation sites, specifically the proximal aortic neck and distal iliac artery interface.

• 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: ida simson ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18674348
• MDR Text Key: 335106955
• Report Number: 3007284313-2024-03040
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P200030
• 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: 05/06/2024

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: CXT231412E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/01/2024
• Initial Date FDA Received: 02/09/2024
• Supplement Dates Manufacturer Received: 03/13/2024; 05/02/2024
• Supplement Dates FDA Received: 04/04/2024; 05/06/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2023
• 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: GORE® DRYSEAL FLEX INTRODUCER SHEATH (DSF1533).
• Patient Sex: Male