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

Model Number	BXA055902A
Medical Device Problem Code	Collapse (1099)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	01/04/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Information obtained from medrio study database: file name: l-change-reint_20220201.Recvd: 2/4/2022.Side branch (vbx) bxa055902a/ 20315585 used in right renal artery (most proximal within the portal) side branch (vbx) bxa071902a/21271667 used in right renal artery (first distal extension) side branch (vbx) bxa 053902a/24277912 used in right renal artery (most proximal within the portal) procedure date: (b)(6) 2019 dr (b)(6).The university of (b)(6).White male, dob (b)(6) 1935, weight (b)(6).Comorbidities: coronary artery bypass graft, percutaneous coronary intervention, coronary artery disease, hypercholesterolemia, hypertension, atrial fibrillation, and colorectal cancer.Medications: aspirin, warfarin, study pt: (b)(6).Adverse event - 03 date of onset - possible right renal artery stent crushed/slightly narrowed ritype: procedure done on (b)(6) 2022, had stent placed (vbx 5 x 39 and an icast 6 x 38).
Additional Manufacturer Narrative
It is unclear as to the identification of which device/devices failed within the procedure, so all 3 will be included in the narrative and manufacturing records were pulled for all 3 devices used.A review of the manufacturing records for lot # 20315585 indicated the device met pre-release specifications.A review of the manufacturing records for lot # 21271667 indicated the device met pre-release specifications.A review of the manufacturing records for lot # 24277912 indicated the lot met pre-release manufacturing specifications.Due to no device return, an investigation could not be performed.
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.

• 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: spencer deboard ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 13664101
• Report Number: 2017233-2022-02783
• Device Sequence Number: 1945319
• Product Code: PRL
• UDI-Device Identifier: 00733132637133
• UDI-Public: 00733132637133
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P160021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2022

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: 01/28/2022
• Device Model Number: BXA055902A
• Device Catalogue Number: BXA055902A
• 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: 02/04/2022
• Supplement Date Received by Manufacturer: 05/02/2022
• Initial Report FDA Received Date: 03/03/2022
• Supplement Report FDA Received Date: 05/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Other
• Patient Age: 86 YR
• Patient Sex: Male
• Patient Weight: 65 KG
• Patient Race: White