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

Catalog Number RLT231412

Device Problem Collapse (1099)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/11/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2016, the patient was implanted with a gore excluder aaa endoprosthesis to treat an abdominal aortic aneurysm.On an unknown date, computed tomography scan reportedly showed the ipsilateral limb (rlt231412/15277585) had collapsed at the level of the contralateral gate.The reason for the device¿s collapse is not known.According to the physician, there was no anatomical constraint affecting the device¿s ability to open.Blood flow through the ipsilateral limb reportedly appeared to be compromised, and the physician felt the limb needed to be ballooned more aggressively.On (b)(6) 2016, the physician advanced and inflated an endovascular balloon to re-open the ipsilateral limb.Patency of the limb was restored, and the patient tolerated the 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 PHOENIX 2 B/P; 32470 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: damon jackson ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 6132058
• MDR Text Key: 61026762
• Report Number: 3007284313-2016-00242
• 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: 11/11/2016

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: 07/15/2019
• Device Catalogue Number: RLT231412
• Device Lot Number: 15277585
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2016
• 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): Hospitalization; Required Intervention
• Patient Age: 65 YR