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

Catalog Number RMT281218J

Device Problems Material Invagination (1336); Inadequacy of Device Shape and/or Size (1583)

Patient Problem Aneurysm (1708)

Event Date 03/30/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2014, the patient underwent endovascular repair of an abdominal aortic aneurysm using gore® excluder® aaa endoprostheses featuring c3® delivery system.Trunk-ipsilateral leg (rmt281218j/12044312) and two contralateral leg components were successfully deployed.The patient tolerated the procedure.On (b)(6) 2018, a follow-up imaging revealed an infolding at the proximal end of the existing trunk-ipsilateral leg component.Additionally, a proximal type i endoleak was present.It was reported that the endoleak occurred due to dilation of the patient¿s proximal neck.The patient¿s proximal neck also had diameters of 21.3 mm ¿ 22.9 mm.On the same day, a reintervention was performed whereby an aortic extender component was implanted proximal to the trunk-ipsilateral leg component.The endoleak was resolved and the patient tolerated the reintervention procedure.

• 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 MOUNTAIN B/P; 3750 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: yutaka uchiya ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 7391275
• MDR Text Key: 104140797
• Report Number: 2017233-2018-00200
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 03/30/2018

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
• Device Expiration Date: 10/31/2016
• Device Catalogue Number: RMT281218J
• Device Lot Number: 12044312
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/03/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2013
• 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: 89 YR