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

Model Number	BXA077902A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/27/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2020 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, and a gore® excluder® iliac branch endoprosthesis in the aaa1701 tambe pivotal study.On (b)(6) 2021 a type iii endoleak was observed.It is unknown at this time which device(s) the endoleak originated from.It was reported that the patient passed away from covid prior to the endoleak being treated.
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 devices included on this report are as follows: gore® excluder® iliac branch endoprosthesis catalog which is captured on manufacturer report #3013164176-2022-01413.Gore® excluder® aaa contralateral leg component catalog #unk/ serial #unk/ udi #unk which is captured on manufacturer report #3013164176-2022-01414.(b)(4).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
Additional information was provided that the location of the type iii endoleak was unable to be discerned with certainty, but was suspected to have originated from either the right or left renal artery bridging stent (gore® viabahn® vbx balloon expandable endoprostheses).No aneurysm enlargement was reported.The cause of the type iii endoleak was reportedly unknown, but it was suspected that it may have been related to either inadequate device overlap of the bridging stent at the portal, or damage to the bridging stent after deployment.However, it was noted that the bridging stents (vbx devices) all appeared fully expanded on the ct scans.It was reported that no specific reintervention was scheduled to treat the endoleak as the patient was suffering from "sequelae" of thrombotic thrombocytopenic purpura which required multiple hospitalizations and active treatment.The subject expired from covid-19 prior to any treatment of the endoleak.
Additional Manufacturer Narrative
Additional information was received that no reintervention was performed or planned to treat the type iii endoleak.Therefore, according to reportability guidelines, the endoleak event does not meet the definition of a reportable adverse event as no patient adverse events occurred.This report will be retracted.Additionally, the gore® excluder® iliac branch endoprosthesis, captured in manufacturer report #3013164176-2022-01413, and the gore® excluder® aaa contralateral leg component, captured in manufacturer report #3013164176-2022-01414, which were referenced in h10/11 of the initial report were deemed unrelated to the type iii endoleak event.Therefore, manufacturer report #3013164176-2022-01413 and manufacturer report #3013164176-2022-01414 have also been retracted.
Event or Problem Description
On (b)(6) 2020, the patient underwent endovascular treatment of a thoracoabdominal aortic aneurysm using a gore® excluder® thoracoabdominal branch endoprosthesis (tambe) and gore® viabahn® vbx balloon expandable endoprostheses (vbx) in the aaa1701 tambe pivotal study.On (b)(6) 2021, a type iii endoleak was observed.It was noted that the location of the type iii endoleak was unable to be discerned with certainty, but was suspected to have originated from either the right or left renal artery bridging stent (vbx device).No aneurysm enlargement was reported.The cause of the type iii endoleak was reportedly unknown, but it was suspected that it may have been related to either inadequate device overlap of the bridging stent at the portal, or damage to the bridging stent after deployment.However, it was noted that the bridging stents all appeared fully expanded on the ct scans.It was reported that no specific reintervention was scheduled to treat the endoleak as the patient was suffering from sequalae of thrombotic thrombocytopenic purpura which required multiple hospitalizations and active treatment.The subject expired from covid-19 prior to any treatment of the endoleak.
Additional Manufacturer Narrative
Additional devices included on this report are as follows: catalog #bxa077902a/ serial #(b)(6)/ udi #(b)(4).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.H6: investigation findings: code c19 - the review of the manufacturing paperwork verified that the lots involved in this event met all pre-release specifications.The gore® viabahn® vbx balloon expandable endoprosthesis instructions for use states the following: "to ensure proper seating, at least 1 cm of overlap between devices is suggested.Endoprosthesis foreshortening should be taken into account to achieve the recommended overlap between devices." 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.As the possibility of reintervention at a later date could not be excluded, the endoleak will be reported.

• 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: 14795351
• Report Number: 2017233-2022-03047
• Device Sequence Number: 5876676
• Product Code: PRL
• UDI-Device Identifier: 00733132637539
• UDI-Public: 00733132637539
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 10/31/2022

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: 06/16/2023
• Device Model Number: BXA077902A
• Device Catalogue Number: BXA077902A
• 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: 09/06/2022; 05/24/2022
• Initial Report FDA Received Date: 06/23/2022
• Supplement Report FDA Received Date: 09/06/2022; 10/31/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: HEPARIN, ASPIRIN 81MG; HEPARIN, ASPIRIN 81MG
• Outcome Attributed to Adverse Event: Other
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 56 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American