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

Model Number	BXA057902A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	02/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional devices implanted and/or related to this event: catalog #plc201400/ serial #(b)(4) / udi (b)(4).Catalog #pll161407/ serial #(b)(4) / udi (b)(4).Cbas® heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.Lot number: the lot number of the device involved in this complaint has been requested but has not yet been provided to gore.Device information: the lot/serial number of the device involved in this complaint has been requested but has not yet been provided to gore.Concomitant medical products and therapy dates: heparin, clopidogrel and aspirin.Device manufacture date: as the device lot/serial number has not been provided, the device manufacture date is unknown.Type of investigation: code 4119 - as the lot/serial number of the device involved in this complaint has been requested but has not yet been provided to gore, no device history record review has been completed.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
Event or Problem Description
The following information was reported to gore through the pivotal study for the gore® excluder® thoracoabdominal branch endoprosthesis (tambe device): on (b)(6) 2020, the patient was implanted with a gore® contralateral leg endoprostheses, and a gore® viabahn® vbx balloon expandable endoprostheses with the gore® excluder® thoracoabdominal branch endoprosthesis (tambe device).The patient was being treated for an aortic aneurysm involving the visceral vessel(s).It was reported that on (b)(6) 2020, images revealed a type ic endoleak.The type ic endoleak was identified on the 1 month duplex us and cta scan.The patient was scheduled for a reintervention surgery with dr.Jordan to treat the type ic endoleak.
Event or Problem Description
The following information was reported to gore through the pivotal study for the gore® excluder® thoracoabdominal branch endoprosthesis (tambe device): on (b)(6) 2020, the patient was implanted with a gore® contralateral leg endoprostheses, and a gore® viabahn® vbx balloon expandable endoprostheses with the gore® excluder® thoracoabdominal branch endoprosthesis (tambe device).The patient was being treated for an aortic aneurysm involving the visceral vessel(s).It was reported that on february 21, 2020, images revealed a type ic endoleak.The type ic endoleak identified on 1 month duplex us and cta scan.Patient scheduled for reintervention surgery with (b)(6) to treat the type ic endoleak.Additional information determined which device had the adverse event reported (type ic endoleak) on it.The (gore® viabahn® vbx balloon expandable endoprosthesis) has the allegation of deficiency.The medwatch (report # 2017233-2022-03048).The endoleak was on the side branch left renal artery.Left side branch vbx not fully engaged, which resulted in a type 1c endoleak.A reintervention occurred on (b)(6) 2020, balloon angioplasty with peripheral stent implanted.The endoleak was resolved and the patient tolerated the procedure.The gore® excluder® aaa endoprosthesis pll161407 lot # 21362777 and the plc201400 lot # 21428790 has no product problem or deficiency caused or contributed to an adverse event/incident for the patient.The medwatch (report # 3013164176-2022-01415) will be retracted.
Additional Manufacturer Narrative
Updated b5 with additional information provided.Updated b2 with additional information provided.Updated c1.Cbas® heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.Updated h6: analysis of production records: a review of the manufacturing records indicated the lots met all pre-release specifications.

• 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: 14795393
• Report Number: 2017233-2022-03048
• Device Sequence Number: 17587309
• Product Code: PRL
• UDI-Device Identifier: 00733132637454
• UDI-Public: 00733132637454
• Combination Product (Y/N): Y
• Initial Reporter State: GA
• 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): 12/14/2022

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: 05/13/2022
• Device Model Number: BXA057902A
• Device Catalogue Number: BXA057902A
• Device Lot Number: 20059749
• 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: 05/24/2022
• Supplement Date Received by Manufacturer: 12/06/2022
• Initial Report FDA Received Date: 06/23/2022
• Supplement Report FDA Received Date: 12/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 70 KG