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

Catalog Number CEB231210A

Device Problems Collapse (1099); Occlusion Within Device (1423); Failure to Advance (2524)

Patient Problems Paralysis (1997); Thrombus (2101); Stenosis (2263); Claudication (2550)

Event Date 09/20/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2016, the patient underwent repair of an abdominal aortic aneurysm and right common iliac artery (rcia) aneurysm with gore excluder aaa endoprostheses.Reportedly, the gore iliac branch endoprosthesis was advanced and deployed without issue.It was reported several unsuccessful attempts were made to obtain guidewire access into the reportedly patent right internal iliac artery (riia).Reportedly there was nothing about the patient's anatomy that contributed to the difficulty advancing the guide wire.The physician elected to remove the guidewire and perform intra-operative imaging.It was reported, imaging identified the riia had collapsed and was no longer patent; however the left internal iliac artery (liia) was reported to be fully patent.The physician elected to advance, from the patient's left side, a contralateral leg component up and over the aortic bifurcation.The device was reportedly deployed upside down within the iliac branch component with intentional coverage of the right internal iliac gate and riia.A trunk-ipsilateral leg component was then advanced and deployed without issue.An additional contralateral leg component was implanted as a bridge between the trunk-ipsilateral leg component and the iliac branch component.Another contralateral leg component was then advanced and deployed 1.5cm proximal to the ostium of the left internal iliac artery (liia).Post-deployment ballooning was performed utilizing a qx medical q50-65p stent graft balloon.It was reported, the balloon was not overinflated or extended outside of the devices during the ballooning process.Final angiography showed an area of slight stenosis located between the distal end of the contralateral leg component and the liia.It was reported, the physician suspected this area of stenosis was caused by a thrombotic clot.Additional imaging revealed the stenotic area to be free of any calcification.The physician elected to balloon the area of stenotic native vessel utilizing a small non-gore balloon (manufacturer unknown).Immediately, following the ballooning, imaging showed the liia had occluded.The non-gore balloon was then used in an effort to dilate the liia.Immediately, following ballooning imaging indicated the liia appeared opened and patent.The physician concluded the procedure without the implantation of a stent within the liia to maintain blood flow.On (b)(6) 2016, it was reported the patient experienced bilateral claudication, and an inability to stand.Ct imaging performed later that same day, indicated the liia had re-occluded.On (b)(6) 2016, the physician notified the fsa that the patient appears to be permanently paralyzed from the waist down.The cause of the paralysis is reportedly unknown.To date a cerebrospinal fluid drain has not been placed, nor have any additional procedures been performed to treat the patient's paralysis.Reportedly, the patient has been administered steroid medication for treatment of the paralysis.The physician will continue to monitor the patient.

• Brand Name: GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL SUNNYVALE B/P; 1327 orleans drive; sunnyvale CA 94089
• Manufacturer Contact: charlene cooper ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 5997065
• MDR Text Key: 56402852
• Report Number: 2953161-2016-00198
• Device Sequence Number: 1
• Product Code: MIH
• 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: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/20/2016

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: 06/09/2019
• Device Catalogue Number: CEB231210A
• Device Lot Number: 15160206
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2016
• 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: 74 YR
• Patient Weight: 71