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

Model Number	BXA095902A
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Transient Ischemic Attack (2109)
Date of Event	01/14/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2021 the patient underwent endovascular treatment of a thoracoabdominal aortic aneurysm using a gore® excluder® thoracoabdominal branch endoprosthesis (tambe), gore® viabahn® vbx balloon expandable endoprostheses (vbx), gore® excluder® aaa contralateral leg components, a gore® excluder® iliac branch endoprosthesis, gore® molding & occlusion balloon catheters, gore® tri-lobe balloon catheters, gore® dryseal flex introducer sheaths, and gore® tri lumen catheters in the aaa1701 tambe pivotal study.On the morning of (b)(6) 2021 the patient reported blurred vision (diplopia).The patient was evaluated by the hospital stroke team and an mri of the patient's brain was performed.It was reported that the mri was without evidence of an acute stroke.It was reported that the patient's blurred vision resolved itself later on the morning of (b)(6) 2021.There was reportedly no residual.
Additional Manufacturer Narrative
Cbas® heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.
Additional Manufacturer Narrative
As it is unknown which device may have caused/contributed to the reported adverse event, the following additional devices have been included on this report: catalog #bxa065902a/ serial #(b)(6)/ udi #(b)(4).Catalog #bxa067902a/ serial #(b)(6)/ udi #(b)(4).Catalog #bxa065902a/ serial #(b)(6)/ udi #(b)(4).Catalog #bxa067902a/ serial #(b)(6)/ udi #(b)(4).Catalog #bxa097902a/ serial #(b)(6)/ udi #(b)(4).As it is unknown which device may have caused/contributed to the reported adverse event, the following device systems have been included in this investigation: gore® excluder® aaa endoprostheses which are captured in manufacturing report #3013164176-2022-01417.Gore® excluder® iliac branch endoprosthesis which is captured in manufacturing report #3013164176-2022-01418.Gore® dryseal flex introducer sheaths which are captured in manufacturing report #3007284313-2022-01988.Gore® tri-lobe balloon catheter which is captured in manufacturing report #3007284313-2022-01986.Gore® tri-lumen catheter which is captured in manufacturing report #3007284313-2022-01989.Gore® molding and occlusion balloon catheter which is captured in manufacturing report #3007284313-2022-01987.B.5.Additional event description added.H.6.Investigation findings: code c19 - the review of the manufacturing paperwork verified that the lots involved in this event met all pre-release specifications.H.6.Investigation conclusions: code d15 - this complaint was initiated based on information received from a clinical study database.The information reported in the complaint does not reasonably suggest that a potential device malfunction has occurred.Neither clinical images enabling direct assessment of product performance nor the product itself were returned for evaluation.Additional information was requested from the field; however, no attributable cause or contributing factors to the adverse event could be identified.Therefore, the cause of the reported adverse event could not be determined with the available information.H.6.Investigation findings: code 3233 updated to code c19.H.6.Investigation conclusions: code 11 updated to code d15.
Event or Problem Description
The possible cause of the transient ischemic attack is reportedly unknown.It was noted that there was nothing that contributed to the event anatomically.
Additional Manufacturer Narrative
H6: investigation conclusions code d15 remains unchanged h.6.Medical device problem code 3190 updated to code a24.
Additional Manufacturer Narrative
C.1.Cbas® heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.H.6.Investigation conclusions code d15 remains unchanged.

• 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: 14796009
• Report Number: 2017233-2022-03049
• Device Sequence Number: 14717060
• Product Code: PRL
• UDI-Device Identifier: 00733132637379
• UDI-Public: 00733132637379
• Combination Product (Y/N): Y
• Initial Reporter State: WI
• 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,Followup,Followup
• Report Date (Section B): 12/15/2022

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: 05/31/2023
• Device Model Number: BXA095902A
• Device Catalogue Number: BXA095902A
• 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: 05/24/2021
• Supplement Date Received by Manufacturer: 09/13/2022; 12/15/2022; 12/15/2022
• Initial Report FDA Received Date: 06/24/2022
• Supplement Report FDA Received Date: 09/13/2022; 12/15/2022; 12/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CLOPIDOGREL 75MG
• Outcome Attributed to Adverse Event: Other
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 78 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White