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

Catalog Number HGB161007A

Device Problems Bent (1059); Difficult or Delayed Positioning (1157); Occlusion Within Device (1423); Material Separation (1562); Physical Resistance (2578); Difficult to Advance (2920)

Patient Problems Intimal Dissection (1333); Thrombus (2101)

Event Date 01/17/2017

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: (b)(4)/15162279 and (b)(4)/15212632.Udi numbers for the lots are as follows: (b)(4).The review of the manufacturing paperwork verified that the lots met all pre-release specifications.

Event Description

On (b)(6) 2017, the patient underwent treatment of an abdominal aortic aneurysm and a right common iliac artery aneurysm with gore® excluder® aaa endoprostheses and iliac branch endoprostheses.Pre-implantation imaging had identified a nonviable left internal iliac artery, therefore the physician planned to save the right internal iliac artery during the implant procedure.During the procedure, an iliac branch component was reportedly positioned and deployed as planned without any reported issues.It was reported the patient had very complex anatomy, a small right internal iliac artery (measuring less than 6mm in diameter) with evidence of calcification at the ostium of the artery.Further, it was reported the entry angle into the ostium was a greater than 90 degree left turn into the artery resulting in difficulty gaining guidewire access.Reportedly, the physician made numerous attempts to gain guidewire access into the right internal iliac artery, however the guidewire continued to ¿pop¿ out of the artery.It was reported, an up-and-over throughwire was established and several non-gore access catheters (manufacturers unknown) were used in an attempt to position the internal iliac component within the right internal iliac artery for deployment.During advancement of the internal iliac component resistance was encountered, reportedly the up and over through wires had become wrapped around the delivery catheter.According to the report, the device was removed from the patient and an intra-operative angiogram was performed.Reportedly, the intra-operative imaging showed a dissection at the bifurcation of the right internal and common iliac arteries.This dissection was reported to have resulted in a ¿flap¿ covering the ostium of the internal artery.It was reported the dissection did not result in significant blood loss nor was a transfusion of blood products required.Additional attempts were made to advance the delivery catheter past the flap covering ostium, when this failed the physician elected to again withdraw the delivery catheter from the patient.A visual inspection was performed which indicated the device had been damaged.Reportedly, the tip of the device appeared bent with a gap between the tip of the delivery catheter and the constrained endoprosthesis.The physician was reported to have stated the integrity of the device may have been compromised, therefore the device was discarded by the facility.A gore® viabahn® (10x5) endoprosthesis was then advanced and implanted into the right internal iliac artery.Another internal iliac component was prepared and advanced through a gore® 12 fr dryseal flex introducer sheath into position and implanted as a bridge between the viabahn endoprosthesis and the iliac branch component.The procedure continued with the implantation the trunk-ipsilateral leg and contralateral leg components on the patient¿s left side, without any reported issues.Intra-operative imaging showed the right side (non-ipsilateral side) of the iliac branch component, the internal iliac component and the viabahn endoprosthesis appeared fully occluded with thrombus.Reportedly, the cause of the device occlusion is unknown, however the physician stated the dissection possibly caused the thrombotic event.A contralateral leg component was implanted, extending distally from the bifurcation of the internal iliac component into the external iliac artery resulting in the intentional coverage of the right internal iliac artery.It was reported, at the conclusion of the procedure, final angiography showed good perfusion bilaterally to the distal extremities.The patient tolerated the procedure.

• 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: 6267707
• MDR Text Key: 65452839
• Report Number: 2953161-2017-00017
• 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: 01/17/2017

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: 04/13/2019
• Device Catalogue Number: HGB161007A
• Device Lot Number: 14970853
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2016
• 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): Other
• Patient Age: 57 YR