MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS; ILIAC COVERED STENT, ARTERIAL

Device Problem Microbial Contamination of Device (2303)

Patient Problem Unspecified Infection (1930)

Event Date 09/04/2020

Event Type  Injury  

Manufacturer Narrative

Additional manufacturer narrative: cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.Additional devices gore® excluder® aaa endoprosthesis (b)(4) and (b)(4) being reported separately under case # (b)(4).A review of the manufacturing and sterilization records for the devices is currently in progress.

Event Description

The following was reported to gore: on (b)(6) 2020, the patient underwent an endovascular procedure to treat an abdominal aortic aneurysm and a left common iliac artery aneurysm using a gore® excluder® aaa endoprosthesis.The left common iliac artery also had stenosis, so a gore® viabahn® vbx balloon expandable endoprosthesis (item/serial # unk) was implanted distal to the left leg of the gore® excluder® aaa endoprosthesis.It was also reported that non-gore bare metal stents were implanted bilaterally because the terminal aorta was narrow.On an unknown date in 2020 (around 3 weeks after the initial procedure), the patient had a fever, and infection of the endoprostheses was suspected.Reportedly, inflammatory response was especially strong around the proximal and distal aspects.No treatment details were reported.The patient is being monitored.The physician reported that the cause of the infection was unknown.Also, the physician reportedly considered that it was possible that there was a pre-existing infectious area in the aneurysm and intraprocedural manipulation caused development of the infection.However, it was also reported no infection was observed at the pre-procedural blood test.

Manufacturer Narrative

H.6.Method code 1: 4119 the requested lot number remains unknown, therefore a review of the manufacturing and sterilization records could not be conducted.

Manufacturer Narrative

H.1.Upon further investigation, it was noted that the possible infection was being monitored and did not require any known treatment and therefore the report is being retracted.

• Brand Name: GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS
• Type of Device: ILIAC COVERED STENT, ARTERIAL
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 10673471
• MDR Text Key: 211300559
• Report Number: 2017233-2020-01347
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): Y
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 07/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2020
• 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: 06/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SEE H.10./11.
• Patient Outcome(s): Hospitalization; Other