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

Catalog Number CEB231410A

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/03/2019

Event Type  Injury  

Event Description

On (b)(6) 2019, this patient underwent endovascular treatment using gore® excluder® aaa endoprosthesis, gore® excluder® iliac branch endoprosthesis (ibe) and gore® viabahn® vbx balloon expandable endoprosthesis for bilateral common iliac artery aneurysm and dissection.On (b)(6) 2019, the patient underwent re-intervention to implant an additional stent graft to extend the gore® excluder® iliac branch endoprosthesis distally as a precaution.There was no endoleak or allegation of deficiency against the ibe device.The patient tolerated the procedure.

• 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: douglas rhodes ; 1500 n. 4th street; 9285263030
• MDR Report Key: 9511562
• MDR Text Key: 173294942
• Report Number: 3013164176-2019-00178
• Device Sequence Number: 1
• Product Code: MIH
• 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: 12/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/29/2022
• Device Catalogue Number: CEB231410A
• Device Lot Number: 20441663
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2019
• 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
• Patient Age: 45 YR