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

Catalog Number RLT261418J

Device Problems Difficult or Delayed Positioning (1157); Insufficient Information (3190)

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

Event Date 11/21/2023

Event Type  Injury  

Manufacturer Narrative

H.6.: code e2403: used as no adverse event to the patient was reported, and the patient tolerated the procedure.H.6.: code b22: results pending completion of investigation.H.6.: code c21: results pending completion of investigation.H.6.: d16: conclusion not yet available h.6.: code a26: results pending completion of investigation.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) 2023, the patient underwent an endovascular treatment of an abdominal aortic aneurysm using gore® excluder® aaa endoprosthesis.After the proximal of the trunk ipsilateral leg endoprosthesis was deployed, it was attempted to cannulate to the contralateral gate.However, it was difficult to cannulate to the gate.Therefore, the ipsilateral leg of the trunk ipsilateral leg was deployed in the right common iliac artery first.Then, the pull-through was attempted to create but the snare was not able to be caught.The approach from the brachial artery was tried, but the guide wire and the snare from the peripheral didn¿t cross.The guide wire was tried to catch in the common iliac artery but the guide wire and the snare didn¿t cross in the common iliac artery.A stiff wire was inserted from the peripheral and it was tried to correct the vessel run but the cannulation was not success.A gore® molding & occlusion balloon catheter was inflated in the trunk ipsilateral leg.And the sheath from the brachial artery was changed to a guiding sheath.But the snare and the guide wire didn¿t cross.A micro catheter and a guide wire (14) were used but it was not success.The multiple attempts were performed to cannulate to the gate, but the cannulation was not success and the physician decided to stop the procedure.A reintervention is planned to complete the procedure on another day.During the procedure, the blood flow of lower limb was checked to confirm whether an ischemia of lower limb occurred or not by the doppler and act, and no complications were observed.Reportedly, the procedure time was long, like total about 7 hours.And a fluoroscopic time was about 3 hours out of 7 hours.The physician stated that the cannulation to the gate was difficult than expected.On (b)(6) 2023, the reintervention was performed to complete the initial procedure.A contralateral leg endoprosthesis was implanted in the right common iliac artery.It was confirmed there was no endoleak and the procedure was concluded.

Manufacturer Narrative

H.6.: investigation conclusions: code d12 removed.

Manufacturer Narrative

H.6.Investigation findings: code c21 updated to code c19.H.6.Type of investigation b22 updated to b20.H.6.Medical device problem code a26 updated to a150203.H.6.Investigation conclusions: code d16 updated to code d12 and d1102.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), physician and patient should review the risks and benefits when discussing this endovascular device and procedure, including possibility that subsequent interventional or open surgical repair of the aneurysm may be required after initial endovascular repair.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), potential device or procedure-related adverse events that may occur and/or require intervention include, but are not limited to improper component placement, and component migration.

Manufacturer Narrative

B.3: date of event in description summary updated to reflect accurate date (b)(6) 2023.

Event Description

The following was reported to gore: on (b)(6) 2023, the patient underwent an endovascular treatment of an abdominal aortic aneurysm using gore® excluder® aaa endoprosthesis.After the proximal of the trunk ipsilateral leg endoprosthesis was deployed, it was attempted to cannulate to the contralateral gate.However, it was difficult to cannulate to the gate.Therefore, the ipsilateral leg of the trunk ipsilateral leg was deployed in the right common iliac artery first.Then, the pull-through was attempted to create but the snare was not able to be caught.The approach from the brachial artery was tried, but the guide wire and the snare from the peripheral didn¿t cross.The guide wire was tried to catch in the common iliac artery but the guide wire and the snare didn¿t cross in the common iliac artery.A stiff wire was inserted from the peripheral and it was tried to correct the vessel run but the cannulation was not success.A gore® molding & occlusion balloon catheter was inflated in the trunk ipsilateral leg.And the sheath from the brachial artery was changed to a guiding sheath.But the snare and the guide wire didn¿t cross.A micro catheter and a guide wire (14) were used but it was not success.The multiple attempts were performed to cannulate to the gate, but the cannulation was not success and the physician decided to stop the procedure.A reintervention is planned to complete the procedure on another day.During the procedure, the blood flow of lower limb was checked to confirm whether an ischemia of lower limb occurred or not by the doppler and act, and no complications were observed.Reportedly, the procedure time was long, like total about 7 hours.And a fluoroscopic time was about 3 hours out of 7 hours.The physician stated that the cannulation to the gate was difficult than expected.On (b)(6) 2023, the reintervention was performed to complete the initial procedure.A contralateral leg endoprosthesis was implanted in the right common iliac artery.It was confirmed there was no endoleak and the procedure was concluded.

• Brand Name: GORE® EXCLUDER® 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: kathryn irwin ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18365259
• MDR Text Key: 331003606
• Report Number: 3007284313-2023-02960
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 02/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: RLT261418J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/21/2023
• Initial Date FDA Received: 12/20/2023
• Supplement Dates Manufacturer Received: 02/16/2024; 02/21/2024; 02/23/2024
• Supplement Dates FDA Received: 02/20/2024; 02/21/2024; 02/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2023
• 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; Required Intervention
• Patient Age: 91 YR
• Patient Sex: Male