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

Device Problems Disconnection (1171); Malposition of Device (2616); Device Dislodged or Dislocated (2923)

Patient Problems Hemorrhage/Bleeding (1888); Ruptured Aneurysm (4436)

Event Date 12/07/2021

Event Type  Injury  

Event Description

The following was reported to gore: patient presented with a ruptured iliac aneurysm.As reported, this patient had an ibe procedure sometime in 2018 (date unknown) utilizing a gore® excluder® iliac branch endoprosthesis (ibe) and three gore® viabahn® vbx balloon expandable endoprosthesis (vbx device(s)).The ibe device was implanted in the common and external iliac artery.The gate extended into the hypogastric artery with three overlapped vbx devices.On (b)(6) 2021, it was found an aneurysm had ruptured due to disconnection of a vbx device and ibe device.As reported, the ibe device remained in place while one vbx device had moved out of place.During the re- intervention, an 8lmm x 79mm vbx device was then advanced and deployed the intended treatment site to successfully re-connect the devices.The procedure ended with good outcome.The patient was recovering well following procedure.On (b)(6) 2021, the physician stated a follow-up ct was taken and the repair of the hypogastric limb looks good with no endoleaks present.Patient was reported to be recovering well.

Manufacturer Narrative

Review of device manufacturing record history could not be conducted as device lot/serial number remains unknown after information was requested.Device remains implanted; therefore, direct product analysis could not be performed.Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.Implant date was entered as (b)(6) 2018 as only the year was provided by user facility.

Manufacturer Narrative

H6 - selections made for health effects, medical device problem and component codes.

• 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
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: genevieve begay ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 13061473
• MDR Text Key: 282773661
• Report Number: 2017233-2021-02631
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 125 KG