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

Catalog Number BXA082901J

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Unspecified Infection (1930)

Event Date 10/17/2023

Event Type  Injury  

Event Description

The following was reported to gore: on (b)(6) 2023, the patient underwent an endovascular treatment of a chronic total occlusion of the right common iliac artery aneurysm and a stenosis of the left common iliac artery using gore® viabahn® vbx balloon expandable endoprostheses.Two gore® viabahn® vbx balloon expandable endoprostheses (8 mm - 29 mm and 8 mm - 59 mm) were implanted in the right common iliac artery and one gore® viabahn® vbx balloon expandable endoprosthesis (8 mm - 59 mm) was implanted in the left common iliac artery using a kissing technique.A type ib endoleak from the gore® viabahn® vbx balloon expandable endoprosthesis which was implanted in the right common iliac artery was observed.Reportedly this type ib endoleak was due to the the right common iliac artery aneurysm was extended to the right external iliac artery but the gore® viabahn® vbx balloon expandable endoprostheses were implanted in the right common iliac artery.No additional treatment was performed for the distal type i endoleak it is unknown which gore® viabahn® vbx balloon expandable endoprosthesis, 8 mm- 29 mm or 8 mm - 59 mm, was related to the distal type i endoleak.Also, gore® viabahn® vbx balloon expandable endoprosthesis (8 mm - 59 mm) was implanted in each the right common iliac artery and the left common iliac artery, but it it is unknown which one was implanted in which side (the right or left).On an unknown date in (b)(6) 2023, a follow-up exam confirmed no issue.In the middle of (b)(6), 2023, the patient visited to the hospital to complain a fever.An infection in gore® viabahn® vbx balloon expandable endoprostheses treated area was suspected.An exam showed that the infection in the right common iliac artery where the treated area of the gore® viabahn® vbx balloon expandable endoprostheses.An antibiotic was given to the patient.Reportedly, there was no finding of the infection on the gore® viabahn® vbx balloon expandable endoprosthesis in the left common iliac artery.The patient condition didn¿t become well after taking the antibiotic.Therefore, a bypass procedure was performed on (b)(6) 2023.An axillofemoral bypass was created, then a femoral-femoral bypass was created.Afterward, the gore® viabahn® vbx balloon expandable endoprostheses in the right common iliac artery which were confirmed the infection were explanted.A puss was observed severely, so the gore® viabahn® vbx balloon expandable endoprosthesis in the left common iliac artery was explanted as well, just in case.The patient tolerated the procedure.The physician stated that the patient¿s adl (activities of daily living) had been low and the patient have a medical history (hypertension, cerebral infraction and paralysis of the left upper and lower limbs) but the cause of infection is unknown at this time.He also mentioned if an infection caused by the device, an infection should occur quickly after the device implantation but for this patient, the infection occurred about 2 months later since the initial procedure, so the infection might have been caused by an endoleak which occurred after the initial procedure, or another reason might have been considered.

Manufacturer Narrative

C1: heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.H3: code "other" was selected as the medical device was discarded at facility.Return not possible.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.

Manufacturer Narrative

Emdr section h6, codes c19, d15, d12 updated to reflect results of investigation.H6: a review of the manufacturing records for the device verified that the lot met all pre-release specifications.H6: code d12: according to the gore® viabahn® vbx balloon expandable endoprosthesis instructions for use (ifu), these complications include, but are not limited to: malapposition, infection.Please note that the same patient was captured in medwatch report number 2017233-2024-04572 and 2017233-2024-04573.

Event Description

The following was reported to gore: on (b)(6) 2023, the patient underwent an endovascular treatment of a chronic total occlusion of the right common iliac artery aneurysm and a stenosis of the left common iliac artery using gore® viabahn® vbx balloon expandable endoprostheses.Two gore® viabahn® vbx balloon expandable endoprostheses (8 mm - 29 mm and 8 mm - 59 mm) were implanted in the right common iliac artery and one gore® viabahn® vbx balloon expandable endoprosthesis (8 mm - 59 mm) was implanted in the left common iliac artery using a kissing technique.A type ib endoleak from the gore® viabahn® vbx balloon expandable endoprosthesis which was implanted in the right common iliac artery was observed.Reportedly this type ib endoleak was due to the the right common iliac artery aneurysm was extended to the right external iliac artery but the gore® viabahn® vbx balloon expandable endoprostheses were implanted in the right common iliac artery.No additional treatment was performed for the distal type i endoleak it is unknown which gore® viabahn® vbx balloon expandable endoprosthesis, 8 mm- 29 mm or 8 mm - 59 mm, was related to the distal type i endoleak.Also, gore® viabahn® vbx balloon expandable endoprosthesis (8 mm - 59 mm) was implanted in each the right common iliac artery and the left common iliac artery, but it it is unknown which one was implanted in which side (the right or left).On an unknown date in (b)(6) 2023, a follow-up exam confirmed no issue.In the middle of december, 2023, the patient visited to the hospital to complain a fever.An infection in gore® viabahn® vbx balloon expandable endoprostheses treated area was suspected.An exam showed that the infection in the right common iliac artery where the treated area of the gore® viabahn® vbx balloon expandable endoprostheses.An antibiotic was given to the patient.Reportedly, there was no finding of the infection on the gore® viabahn® vbx balloon expandable endoprosthesis in the left common iliac artery.The patient condition didn¿t become well after taking the antibiotic.Therefore, a bypass procedure was performed on (b)(6) 2023.An axillofemoral bypass was created, then a femoral-femoral bypass was created.Afterward, the gore® viabahn® vbx balloon expandable endoprostheses in the right common iliac artery which were confirmed the infection were explanted.A puss was observed severely, so the gore® viabahn® vbx balloon expandable endoprosthesis in the left common iliac artery was explanted as well, just in case.The patient tolerated the procedure.The physician stated that the patient¿s adl (activities of daily living) had been low and the patient have a medical history (hypertension, cerebral infraction and paralysis of the left upper and lower limbs) but the cause of infection is unknown at this time.He also mentioned if an infection caused by the device, an infection should occur quickly after the device implantation but for this patient, the infection occurred about 2 months later since the initial procedure, so the infection might have been caused by an endoleak which occurred after the initial procedure, or another reason might have been considered.Additional comment from the physician; the physician commented that the cause of the infection is unknown but there was possibility it could be considered that the right common iliac artery aneurysm might have been infected before the initial procedure.

• Brand Name: GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS
• Type of Device: PRL / 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: asami aizawa ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18603582
• MDR Text Key: 334027660
• Report Number: 2017233-2024-04571
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: BXA082901J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male