MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE MOLDING & OCCLUSION BALLOON CATHETER; CATHETER, PERCUTANEOUS

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problem Perforation of Vessels (2135)

Event Date 08/12/2020

Event Type  Injury  

Event Description

It was reported that the patient presented with an abdominal aortic aneurysm that was treated with a gore® excluder® conformable aaa endoprosthesis with active control system (cxt).It was stated that the cxt was advanced as intended, but that it appeared difficult to cannulate the contralateral leg of the device.It was stated that it took several attempts to advance the guidewire through the gate.It was stated that the narrow aorta as well as calcification in the area of the aortic bifurcation might have contributed to the issue.Additionally, it was stated that the contralateral leg (plc) on the left side was placed as intended and ballooned afterwards with a gore® molding & occlusion balloon (mob).Afterwards a rupture of the left external artery was identified that was treated with the implantation of an additional plc.The left internal iliac artery was needed to be covered.It is assumed that the ballooning of the plc with the mob created the rupture and that the balloon might have been slightly outside of the device during ballooning.The patient tolerated the procedure.

Manufacturer Narrative

H6: method code and result code updated.H6: code 213 - the review of the manufacturing paperwork verified that this lot met all pre-release specifications.

• Brand Name: GORE MOLDING & OCCLUSION BALLOON CATHETER
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 10507156
• MDR Text Key: 206104475
• Report Number: 3007284313-2020-01058
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• PMA/PMN Number: K172567
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 01/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR