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

Model Number	BXA093902A
Medical Device Problem Code	Collapse (1099)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/28/2020
Type of Reportable Event	Malfunction
Additional 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.Device available for evaluation: as it is not known which device, or if both became compressed, the following additional device is being investigated: bxa085902a.Sn: (b)(4).Udi: (b)(4).
Event or Problem Description
The following information was reported to gore: on (b)(6) 2020 a patient was undergoing treatment of a thoraco-abdominal aneurysm within the aaa17-01 tambe clinical study.Gore® viabahn® vbx balloon expandable endoprostheses were utilzed in the branch vessels.A gore® excluder® iliac branch endoprosthesis was used in the iliac artery region.On (b)(6) 2020 imaging revealed the following: the celiac artery side branch component is compressed as it passes between the sma side branch component and the aortic component.The celiac artery side branch component wraps 360 degrees around the sma side branch component.The patient is being monitored.
Additional Manufacturer Narrative
B.5.Updated.H.6.Results code 1: 213: a review of the manufacturing records for the devices verified the lots met all pre-release specifications.
Event or Problem Description
The following information was reported to gore: on (b)(6) 2020 a patient was undergoing treatment of a thoraco-abdominal aneurysm within the aaa17-01 tambe clinical study.Gore® viabahn® vbx balloon expandable endoprostheses were utilzed in the branch vessels.A gore® excluder® iliac branch endoprosthesis was used in the iliac artery region.On (b)(6) 2020 imaging revealed the following: the celiac artery side branch component is compressed as it passes between the sma side branch component and the aortic component.The celiac artery side branch component wraps 360 degrees around the sma side branch component.Small amount of thrombus present in the lsa.Pedunculated lesion just proximal to the tambe aortic component within the aorta.Type ii endoleak with ima and lumbar artery involvement.The imaging finding was clarified further as follows: the ca and sma devices are wrapped around each other in the aorta before each reaches their respective vessels.

• Brand Name: GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS
• Common Device Name: ILIAC COVERED STENT, ARTERIAL
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 11448856
• Report Number: 2017233-2021-01747
• Device Sequence Number: 3243418
• Product Code: PRL
• UDI-Device Identifier: 00733132637355
• UDI-Public: 00733132637355
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P160021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/01/2023
• Device Model Number: BXA093902A
• Device Catalogue Number: BXA093902A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/09/2021
• Supplement Date Received by Manufacturer: 03/11/2021
• Initial Report FDA Received Date: 03/09/2021
• Supplement Report FDA Received Date: 03/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 67 YR
• Patient Weight: 61