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

Catalog Number RMT281218

Device Problems Material Invagination (1336); Activation Failure (3270)

Patient Problem No Code Available (3191)

Event Date 07/08/2014

Event Type  Injury  

Event Description

On (b)(6) 2014, the patient underwent treatment of an abdominal aortic aneurysm with five gore® excluder® aaa endoprostheses featuring c3® delivery system.It was reported the patient¿s proximal aortic neck was slightly angulated and moderately calcified.Final angiography showed the trunk-ipsilateral leg component had failed to fully expand and remained slightly invaginated due to an area of calcification.On (b)(6) 2015, an intervention was performed to treat the slight infolding of the device.A palmaz® stent graft was implanted into the superior portion of the trunk to restore radial force.No occlusion of the device was reported, and the patient tolerated the procedure.

Manufacturer Narrative

The review of the manufacturing paperwork verified that this lot met all pre-release specifications.

Manufacturer Narrative

(b)(4).

• 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 86001
• Manufacturer Contact: charlene cooper ; 1500 n. 4th street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 4560728
• MDR Text Key: 5560304
• Report Number: 2017233-2015-00123
• 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,Followup
• Report Date: 03/04/2015

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: 06/30/2016
• Device Catalogue Number: RMT281218
• Device Lot Number: 11693734
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/02/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/04/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2013
• 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: 77 YR