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

Catalog Number HGB161407

Device Problems Complete Blockage (1094); Collapse (1099); Obstruction of Flow (2423)

Patient Problems Occlusion (1984); Thrombus (2101)

Event Date 02/05/2019

Event Type  Injury  

Manufacturer Narrative

Imaging evaluation: post-implantation computer-tomographic angiographic (cta) images, dated (b)(6) 2019, were provided to gore for evaluation.The evaluation showed the following: the length from the right renal artery to the proximal circumferential device appears to be approx.2cm ¿ 2.8cm.The diameters within this portion of the aorta appear to range from 25.3mm ¿ 27.8mm.There appears to be lack of proximal device/aortic wall apposition at the proximal aortic curve.Comparison axial images appear to show contrast outside the implanted device pooling in the aneurysmal sac at a level approx.34mm distal to the right renal artery.Cannot confirm or totally rule out a proximal type i endoleak with available imaging.There appears to be an increase in pooling contrast on the delayed series images.There appears to be at least 2 sets of lumbar arteries with contrast that appear to communicate with contrast in the aneurysmal sac.Cannot confirm ante grade or retrograde flow.The device limb in the riia appears to be occluded beginning just proximal to the flow divider.The distal end of the internal component in the riia appears to be unopened.Cannot confirm distal diameters of the riia without pre-implantation imaging.The event was identified based on the imaging evaluation performed for gore event (b)(4) (medwatch # 3007284313-2019-00174).

Event Description

The following was reported to gore: on (b)(6) 2015, the patient presented with an abdominal aortic aneurysm and aneurysms in both common iliac arteries that were treated with gore® excluder® aaa endoprostheses and gore® excluder® iliac branch endoprostheses (ibe).On a post-implantation cta, dated (b)(6) 2019, the distal end of the gore® excluder® internal iliac component (hgb), which was implanted in the right internal iliac artery (riia), appears to be unopened.The ibe appears to be occluded beginning just proximal to the flow divider of the gore® excluder® iliac branch component (ceb).

Event Description

The following was reported to gore: on (b)(6), 2015, the patient presented with an abdominal aortic aneurysm and aneurysms in both common iliac arteries that were treated with gore® excluder® aaa endoprostheses and gore® excluder® iliac branch endoprostheses (ibe).It was stated that during the operation thrombus was visible in the iliac region.Therefore a thrombectomy was performed.On a post-implantation cta, dated (b)(6), 2019, the distal end of the gore® excluder® internal iliac component (hgb), which was implanted in the right internal iliac artery (riia), appears to be unopened.The ibe appears to be occluded beginning just proximal to the flow divider of the gore® excluder® iliac branch component (ceb).No reintervention was performed as the patient was asymptomatic.

Manufacturer Narrative

Updated: - b5/ event description.H6: added patient code 2; corrected device code 1; corrected conclusion code 1.

• Brand Name: AORTIC EXCLUDER ILIAC BRANCH ENDOPROSTHESIS (IBE)
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8849596
• MDR Text Key: 152947884
• Report Number: 2953161-2019-00052
• 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: study
• Type of Report: Initial,Followup
• Report Date: 10/15/2019

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 Expiration Date: 06/30/2017
• Device Catalogue Number: HGB161407
• Device Lot Number: 12960735
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/01/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 65 YR
• Patient Weight: 74