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

Model Number BXA087902A

Device Problem Separation Problem (4043)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/27/2020

Event Type  Injury  

Manufacturer Narrative

Additional device information: bxa087902a serial number: (b)(4) udi: (b)(4) as it is not known which device became separated from the other, both devices are being investigated.

Event Description

On (b)(6) 2020 a patient underwent an endovascular procedure in the (b)(6) study.Gore® viabahn® vbx balloon expandable endoprostheses were utilized in the branch vessels.On (b)(6) 2020 imaging revealed that the two vbx devices which were deployed in the superior mesenteric artery had become separated.On (b)(6) 2020 a reintervention to treat the type iii endoleak was performed.An additional vbx was deployed to bridge the separation and the endoleak was considered resolved.The patient tolerated the procedure.On (b)(6) 2020 the patient was discharged.

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.H.6.Results code 1: 213: a review of the manufacturing records for the device verified the lot met pre-release specifications.

Manufacturer Narrative

H.6.Results code 1: 213 a review of the manufacturing records for both devices verified the lots met all pre-release specifications.

• 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: 10813680
• MDR Text Key: 215512174
• Report Number: 2017233-2020-01433
• Device Sequence Number: 1
• Product Code: PRL
• UDI-Device Identifier: 00733132637799
• UDI-Public: 00733132637799
• Combination Product (y/n): Y
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Type of Report: Initial,Followup,Followup
• Report Date: 01/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/30/2023
• Device Model Number: BXA087902A
• Device Catalogue Number: BXA087902A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/29/2020
• Initial Date FDA Received: 11/09/2020
• Supplement Dates Manufacturer Received: 12/28/2020; 01/13/2021
• Supplement Dates FDA Received: 01/12/2021; 01/21/2021
• Patient Sequence Number: 1
• Treatment: SEE H.10./11.
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 71 YR
• Patient Weight: 62