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

Catalog Number CEB231010A

Device Problem Compatibility Problem (2960)

Patient Problem Aneurysm (1708)

Event Date 08/23/2019

Event Type  Injury  

Manufacturer Narrative

According to the instructions for use (ifu) for the gore® excluder® iliac branch endoprostheses; adverse events that may occur include, but are not limited to include: endoleak a review of the manufacturing records for the device(s) verified that the lot(s) met all pre-release specifications.

Event Description

On (b)(6) 2019, this patient underwent endovascular treatment for an abdominal aortic aneurysm, a right common iliac artery aneurysm and a left internal iliac artery aneurysm (liia) and was implanted with gore® excluder® aaa endoprostheses and gore® excluder® iliac branch endoprostheses.Additionally, coil embolization of the left internal iliac artery was performed.On an unknown date one week later, estimated to be on or about (b)(6) 2019, follow-up examination revealed a type iii endoleak around right contralateral leg endoprosthesis.On (b)(6) 2019, the patient underwent re-intervention to treat the type iii endoleak.It was determined that the type iii endoleak was from a suspected disconnect of the contralateral leg component used as the bridge graft to the iliac branch component (ibc).An a additional stent graft was implanted to reline the overlap zone of the bridge graft and the ibc.The type iii endoleak was resolved however angiography revealed a type ii endoleak from the origin of a lumbar artery.The patient tolerated the procedure and the type ii endoleak will be monitored by the physician.

• 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: laura crawford ; 1500 n. 4th street; 9285263030
• MDR Report Key: 9097368
• MDR Text Key: 159331269
• Report Number: 3013164176-2019-00119
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132635283
• UDI-Public: 00733132635283
• 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: 08/30/2019

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: 04/10/2022
• Device Catalogue Number: CEB231010A
• Device Lot Number: 20466572
• 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: 09/20/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2019
• 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; Other; Required Intervention
• Patient Age: 81 YR