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

Device Problems Collapse (1099); Patient-Device Incompatibility (2682)

Patient Problems Therapeutic Response, Decreased (2271); Vascular System (Circulation), Impaired (2572)

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing records could not be performed as the lot # number was not available.Additional information was requested but not available.Please note that the following literature article has been attached to this report: miltiadis i.Matsagas, md, ebsq-vasc, john c.Papakostas, md, helen m.Arnaoutoglou, md, and lampros k.Michalis, md, "abdominal aortic endograft proximal collapse: successful repair by endovascular means", j vasc surg, vol.49, no.5, 2009, pp.1316-1318.(b)(4).

Event Description

During a review of published literature, the following findings were noted: on an unknown date, this patient underwent endovascular treatment for an abdominal aortic aneurysm (aaa) measuring 5.5 cm in diameter and was treated with gore® excluder® aaa endoprostheses.The aortic neck was reported to have been slightly angulated with a diameter of 24 mm and a length of 20 mm.Final angiography revealed adequate graft interposition with aneurysm sac exclusion and no endoleak.On an unknown date at one month follow-up, computed tomography (ct) showed a proximal infolding of the gore® excluder® trunk-ipsilateral leg component with a figure of eight configuration.Due to the patient¿s renal impairment, ct angiography was not performed and no potential endoleak could be identified.Also, there was no distal device migration apparent.As a potential underlying cause for the collapse, the physician supposed that, as the aortic segment covered by the device was quite short for this particular angulation, the increased angle of the graft extending into the aortic lumen might have led to proximal circumferential infolding and insufficient wall apposition.Additionally, no anatomical particulars, atherosclerotic plaques or thrombus were determined.In an attempt to remodel the device collapse the following day, initial ballooning was unsuccessful.It was therefore decided to deploy a talent aortic cuff with suprarenal fixation at the site of device infolding.Post-procedure ct angiography confirmed normal cuff expansion inside the proximal part of the trunk component with the previous infolding no longer persisting.Follow-up ct angiography imaging at one, six and twelve months after the secondary intervention showed normal endograft lumen, and neither endoleak nor migration.

Manufacturer Narrative

Please note: the event reported in this medwatch has been found to be a duplicate of our event# (b)(4) with the final follow-up report sent to you on (b)(6) 2009.As no additional information was reported in this event, it was decided that this medwatch report be retracted.

• Brand Name: GORE® EXCLUDER® AAA ENDOPROSTHESIS
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL WOODY SPRINGS B/P; 3450 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: thomas giebing ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 6829466
• MDR Text Key: 83947489
• Report Number: 2017233-2017-00435
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,litera
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/06/2017

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/30/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Required Intervention
• Patient Age: 78 YR