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

Catalog Number RLT261212

Device Problems Bent (1059); Material Deformation (2976)

Patient Problem Claudication (2550)

Event Date 05/05/2015

Event Type  Injury  

Event Description

On (b)(6) 2015, patient was treated for a right common iliac artery aneurysm and left common iliac artery ectasia with five gore® excluder® aaa endoprostheses.It was reported one trunk-ipsilateral leg component device was placed in the right common iliac artery and the other in the infrarenal aorta.Two gore® viabahn® endoprostheses devices were placed in the right hypogastric artery to bridge to the main body in the right common iliac artery.The two trunk-ipsilateral leg components were bridged with a contralateral leg component.It was reported all of the devices were placed without complication and final angiography showed aneurysm exclusion and successful placement of all devices.On (b)(6) 2015, the patient returned to the hospital complaining of claudication.Imaging reportedly revealed the trunk-ipsilateral leg component was bent in on the proximal end.It was noted that the infrarenal neck angulation had increased significantly.The size of the common iliac artery aneurysm had been reduced dramatically (amount unknown).It was reported that the morphologic change exacerbated the infrarenal neck angulation, leading to a "bird-beak" effect that subsequently lead to the device bending in at the proximal end.An aortic extender component was placed with in the proximal most trunk-ipsilateral leg component at the level of the lowest renal artery, successfully correcting the bending of the proximal end of the device.It was reported the patient tolerated the procedure and the physician will continue to monitor the patient.

Manufacturer Narrative

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

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).Patient's medications: morphine, oxycodone, gabapentin, docusate, warfarin, albuterol, doxazosin, l-arginine, losartan, potassium, metoprolol, omeprazole, and simvastatin.

• 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 PHOENIX 2 B/P; 32470 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: marcos ayala ; 1500 n. 4th street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 4820208
• MDR Text Key: 5919806
• Report Number: 3007284313-2015-00057
• 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,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/20/2015

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: 09/30/2017
• Device Catalogue Number: RLT261212
• Device Lot Number: 13136971
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/04/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2014
• 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: 62 YR
• Patient Weight: 90