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

Catalog Number HGB161207

Device Problem Material Invagination (1336)

Patient Problem Aneurysm (1708)

Event Date 10/23/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was discarded at the facility and not available for analysis.The gore® excluder® iliac branch endoprosthesis instructions for use (ifu) states: do not continue advancing and withdrawing any portion of the delivery system if resistance is felt during advancement of the guidewire, sheath, or catheter.Stop and assess the cause of resistance.Vessel or catheter damage may occur.According to the gore® excluder® iliac branch endoprosthesis instructions for use (ifu), additional considerations for patient selection include but are not limited to patient¿s anatomical suitability for endovascular repair.

Event Description

On (b)(6) 2018, a gore® excluder® iliac branch endoprostheses (ibe) was intended to be used to treat a patient¿s bilateral common iliac artery (cia) aneurysms.The right iliac branch endoprosthesis was successfully implanted.During the implant process an internal iliac component ((b)(4)) would not track into the gate of the ibe, appearing to catch on the flow divider.The sheath was repositioned, however ultimately the decision was made to remove the device.While attempting to remove the device, visible compression of the stent was identified.It was reported that the ostium was noted to be narrow.The procedure was completed using additional devices.The patient tolerated the procedure.

Manufacturer Narrative

This report is being sent as a retraction to the initial report.Additional information received from the product manager demonstrated the device did not deploy, still remained on the catheter, and the device was not compressed as originally reported.Based on this additional clarification, the event no longer meets the criteria of a reportable malfunction, therefore gore is retracting this report.

Event Description

This report is being sent as a retraction to the initial report.Additional information received from the product manager demonstrated the device did not deploy, still remained on the catheter, and the device was not compressed as originally reported.Based on this additional clarification, the event no longer meets the criteria of a reportable malfunction, therefore gore is retracting this report.

• 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
• MDR Report Key: 8081057
• MDR Text Key: 128410731
• Report Number: 3013164176-2018-00110
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 12/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/06/2020
• Device Catalogue Number: HGB161207
• Device Lot Number: 17532117
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/16/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 79 YR