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

Catalog Number PXC141200

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Rupture (2208)

Event Date 04/09/2024

Event Type  Injury  

Manufacturer Narrative

The instructions for use (ifu) for the gore® excluder® aaa endoprosthesis states, adverse events that may occur and / or require intervention include but are not limited to: aneurysm enlargement, aneurysm rupture.B7: patient medical history includes but is not limited to: hypertension, afib.D10: patient medications include but are not limited to: biotin, cetirizine,vitamin b12, flexeril, ferrous gluconate, lasix, femara, toprol xl, oxycodone, pantprazole, rivarosaban, zoloft, ultram, verapamil, tramadol, verapamil.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

On (b)(6) 2015, this patient underwent endovascular treatment for an abdominal aortic aneurysm (aaa) and bilateral common iliac artery aneurysms (ciaa).The aaa was treated with a gore excluder aaa endoprostheses (rlt261418/(b)(6)).Computed tomography angiography (cta) this date determined the aaa maximum diameter measured 68mm, the left common iliac artery aneurysm (lciaa) maximum diameter measured 60mm; and the right common iliac artery aneurysm (rciaa) maximum diameter measured 45mm.The lciaa was treated with a pxc141400/(b)(6) and a pxc141200/ (b)(6) with embolization of the liia.The rciaa, the ipsilateral side was extended with a pxc141200/13972402 with coil embolization of riia.The patient is reported to have a maximum infrarenal neck angle of 75 degrees, a proximal landing zone diameter ranging 23-19mm.The patient tolerated the procedure and was discharged from the hospital on (b)(6) 2015.On (b)(6) 2015, follow-up computed tomography angiography (cta) reports the maximum diameter of the aaa measured 63mm, the maximum diameter of the lciaa measured 41mm and the maximum diameter of the rciaa measured 53mm.On (b)(6) 2023, follow-up cta reports the maximum diameter of the aaa measured 40mm.No diameter measurement for the lciaa or rciaa were provided.No endoleaks post implant have been reported for the patient.On (b)(6) 2024, it was reported that the patient presented to the emergency room of a different hospital with a ruptured abdominal aortic aneurysm requiring treatment.This same day (approximately 2 hrs.Later) the patient was transferred/admitted to the treatment facility and was diagnosed with a retroperitoneal hemmorrhage and atrial fibrillation with rvr (hcc) and was on apixaban therapy.Cta was performed and showed a large pelvic hematoma likely arising from rupture of a newly expanding aortic rhythm sac status post pervious endograft repair.Surgical intervention is possible, the patient is being monitored in the intensive care unit (icu).

• 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 SUNNYVALE B/P; 1327 orleans drive; sunnyvale CA 94089
• Manufacturer Contact: 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 19131074
• MDR Text Key: 340448344
• Report Number: 2953161-2024-01210
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132609956
• UDI-Public: 00733132609956
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/17/2024

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 Expiration Date: 05/31/2018
• Device Catalogue Number: PXC141200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/09/2024
• Initial Date FDA Received: 04/18/2024
• Date Device Manufactured: 06/11/2015
• 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): Hospitalization; Other
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 140 KG
• Patient Race: White