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

Model Number	BXA075902A
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2021
Type of Reportable Event	Serious Injury
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.Concomitant medical products and therapy dates: tylenol 325mg, asa 81mg, atenolol 25mg, mvi, zocor 20mg.
Event or Problem Description
On (b)(6) 2021 the patient underwent endovascular treatment of a thoracoabdominal aortic aneurysm using gore® excluder® thoracoabdominal branch endoprostheses (tambe) and gore® viabahn® vbx balloon expandable endoprostheses (vbx) in the (b)(6)study.On (b)(6) 2021 the patient was discharged.On (b)(6) 2021 one month post-op cta imaging revealed a type iii endoleak between the tambe device and the gore® viabahn® vbx balloon expandable endoprosthesis in the patient's left renal artery.It was reportedly suspected that the type iii endoleak was related to inadequate overlap of the devices into the patient's left renal artery.It was reported that the device overlap was too short.On (b)(6) 2021 a left brachial cutdown, second order cannulation of the patient's left renal artery, and a selective left renal angiogram were performed.The physician performed left renal artery angioplasty, and an additional vbx device was placed.It was the opinion of the physician that the patient would benefit from an extension of the left renal stent for branch stability at a later date.There were no further reported issues.The patient tolerated the intervention.
Additional Manufacturer Narrative
H.6.Investigation findings: code 213 - the review of the manufacturing paperwork verified that the lots involved in this event met all pre-release specifications.B.5.Description of event: correction made to date of endoleak identification from (b)(6) 2021 to (b)(6) 2021.B.3.Date of event remains unchanged.H.6.Investigation findings: code 3233 updated to code 213.H.6.Investigation conclusions: code 11 updated to code 4311.
Event or Problem Description
Correction: one month post-op cta imaging and identification of the type iii endoleak occurred on (b)(6), 2021.

• 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
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: jenna lopez ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 13211327
• Report Number: 2017233-2022-02661
• Device Sequence Number: 1686638
• Product Code: PRL
• UDI-Device Identifier: 00733132637294
• UDI-Public: 00733132637294
• Combination Product (Y/N): Y
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P160021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 02/18/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2024
• Device Model Number: BXA075902A
• Device Catalogue Number: BXA075902A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2021
• Supplement Date Received by Manufacturer: 01/21/2022
• Initial Report FDA Received Date: 01/10/2022
• Supplement Report FDA Received Date: 02/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 65 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White