MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES AORTIC EXCLUDER ILIAC BRANCH ENDOPROSTHESIS (IBE); SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number CEB231210A

Device Problem Occlusion Within Device (1423)

Patient Problem Pain (1994)

Event Date 05/23/2018

Event Type  Injury  

Manufacturer Narrative

The review of the manufacturing paperwork verified that this lot met all pre-release specifications.(b)(4).

Event Description

On (b)(6) 2018, this patient underwent an endovascular repair for abdominal aortic aneurysm with iliac artery aneurysm using a gore® excluder® aaa endoprosthesis, a gore® excluder® iliac branch endoprosthesis and a gore® viabahn® endoprosthesis with heparin bioactive surface.An iliac branch component and an internal iliac component with a gore® viabahn® endoprosthesis with heparin bioactive surface were implanted in the patient's left side.The right internal iliac artery was coil embolized and intentionally covered by an ipsilateral leg of a trunk-ipsilateral leg component.A bare metal stent (smart) was implanted in the bilateral external iliac artery, distal to the endoprosthesis.Final angiography showed no issues, and the patient reportedly tolerated the procedure.On or around (b)(6) 2018, it was reported that buttock claudication developed.On (b)(6) 2018, computed tomography confirmed that the endoprostheses was occluded around an overlap area between a contralateral leg component (bridging component) and the iliac branch component.On (b)(6) 2018, a re-intervention was performed to repair the occlusion.A thrombectomy was performed, and a bare metal stent (smart) was additionally implanted inside the endoprosthesis.Good distal perfusion was observed, and the patient reportedly tolerated the re-intervention.

• Brand Name: AORTIC EXCLUDER ILIAC BRANCH ENDOPROSTHESIS (IBE)
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL SILICON VALLEY B/P; 2890 de la cruz blvd.; santa clara CA 95050
• Manufacturer Contact: rachael chascsa ; 1500 n. 4th street; 9285263030
• MDR Report Key: 7636534
• MDR Text Key: 112285656
• Report Number: 3013164176-2018-00057
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132635290
• UDI-Public: 00733132635290
• 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: 05/31/2018

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: 10/10/2020
• Device Catalogue Number: CEB231210A
• Device Lot Number: 17325954
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2017
• 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: 76 YR