MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3); SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Device Problem Collapse (1099)

Patient Problem Occlusion (1984)

Event Date 03/18/2017

Event Type  Injury  

Manufacturer Narrative

Date the incident occurred is unknown, so the date of online publication of the article was used as the incident date.

Event Description

The article ¿long-term outcome of the gore excluder aaa endoprosthesis for treatment of infrarenal aortic aneurysms¿, published by c.Poublon et.Al, in the journal of vascular and interventional radiology, circulated online on march 18, 2017, reviewed 248 patients undergoing elective endovascular aneurysm repair with gore® excluder® aaa endoprostheses between january 2000 and december 2015 in 2 hospitals.Cardiovascular risk factors were present in most of the patients, and 41.9% of the patients had a high operative risk (american society of anesthesiologists class iii or iv).The mean maximum aneurysm diameter was 59.1mm ± 9.6 (range, 30¿96 mm).Three patients with a saccular aneurysm were treated for an aneurysm diameter < 50 mm.The mean infrarenal aortic neck diameter was 22.9 mm ± 2.4, the mean neck length was 32.3 mm ± 11.9, and the mean infrarenal neck angle (beta angle) was 23.6_ ± 21.9.A saccular aneurysm was present in 11 patients (4.4%), and an inflammatory aneurysm was present in 3 patients (1.2%).Besides the infrarenal aneurysm, 25 patients (10%) also had a concomitant common iliac artery aneurysm, and 5 patients (2%) also had an internal iliac artery aneurysm.There were 61 patients (24.6%) treated outside the instructions for use (ifu) of the device, mainly owing to the diameter of the common iliac artery, and 4.8% of the patients had a hostile aortic neck anatomy.All patients underwent computed tomography (ct) angiography before the procedure.Based on the anatomic suitability, the choice for endovascular treatment with the gore excluder was made by a vascular surgeon and an interventional radiologist.Early on, procedures were performed in an operating room using a mobile image intensifier and later on in a dedicated angiosuite, following the ifu.Antibiotic prophylaxis and heparin were given.Follow-up included clinical examination, abdominal radiography, duplex ultrasound scanning, and ct angiography.Surveillance protocols differed slightly between hospitals and evolved over time.In general, a routine follow-up visit occurred at 1¿3 months, 12 months, and annually thereafter.Among others the article lists ¿folding proximal stent graft¿ as an adverse event that occurred in one patient and that was treated with a proximal stent graft extension.

Manufacturer Narrative

Added literature.

• Brand Name: AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3)
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 7976959
• MDR Text Key: 124067143
• Report Number: 2017233-2018-00623
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 11/06/2018

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/18/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR