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

Catalog Number BXA055902E

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Aneurysm (1708)

Event Date 08/20/2021

Event Type  Injury  

Manufacturer Narrative

The device remains implanted in the patient.Therefore a device evaluation could not be performed.Requests were emailed to the principal investigator and primary study coordinator to clarify details of the event.The provided information is included in the event description.Psc emailed request to the clinical study managers to provide her with a contact to clarify the event.Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.

Event Description

On (b)(6) 2019, the patient underwent a branched endovascular aortic repair (bevar) for a thoracoabdominal aneurysm type v.As the mainbody endograft a customized endograft (cook medical) was used.Four gore® viabahn® vbx balloon expandable endoprostheses (viabahn® vbx devices) were implanted as branch devices to the celiac artery, the superior mesenteric artery and the left and right renal artery.Percutaneous axillary access was gained by a down-cut.During the procedure heparin was used as antiplatelet/anticoagulant.The study database indicates that all viabahn® vbx devices were successfully placed and deployed as intended without abnormalities noticed.All viabahn® vbx devices were patent at the end of the procedure.On (b)(6) 2021, an endoleak of unknown type and origin was reported.No reintervention was performed.On (b)(6) 2021, the physician stated, that in the meantime they think that the endoleak comes most probably from the viabahn® vbx device implanted in the celiac artery.They suspect that he implanted the viabahn® vbx device not far enough distally in the celiac artery.The physician stated, that based on this, the viabahn® vbx device didn´t really contribute to the endoleak.A reintervention is planned to treat the endoleak be extending the viabahn® vbx device distally.

Manufacturer Narrative

H6-code 213: a review of the manufacturing records indicated the device met pre-release manufacturing specifications.The device remains implanted in the patient.Therefore a device evaluation could not be performed.Dicom imaging series have been requested but could not be disclosed to gore for privacy reasons.Therefore, an imaging evaluation could not be performed.Based on the event description and the subsequent investigation, we are unable to determine the cause of this incident and assign a root cause.

Manufacturer Narrative

H6-code 61: an adverse event appears to have occurred, but there does not appear to have been a problem with the device or the way it was used.As reported to gore, the physician stated, that he suspects he implanted the viabahn® vbx device not far enough distally in the celiac artery.The physician stated, that based on this, the viabahn® vbx device didn´t really contribute to the endoleak, therefore an unintended use error may have caused or contributed to the incident.In the instructions for use the following is stated: section d "sizing and selection of the gore® viabahn® vbx balloon expandable endoprosthesis" aneurysmal lesions: to assure adequate anchoring, the diameter of the endprosthesis should be approximately 5 - 20% or 1 mm larger than the healthy vessel diameter proximal and distal to the lesion.To prevent endoprosthesis migration, care should be taken to ensure the device is sufficiently apposed to the vessel wall between initial device deployment and post-dilatation (if performed).The endoprosthesis lengths of the gore® viabahn® vbx balloon expandable endoprosthesis listed in table 1 are nominal.Wherever appropriate, it is recommended that the endoprosthesis overlap the native vessel at least 1 cm beyond the proximal and distal margins of the lesion when treating stenotic or occlusive lesions and preferably at least 2 cm beyond the proximal and distal margins of the lesion when treating aneurysmal lesions.Endoprosthesis foreshortening should be taken into account to achieve the recommended lesion coverage.Section f "introduction and positioning of the gore® viabahn® vbx balloon expandable endoprosthesis" note: if pta is performed, the endoprosthesis length should cover the entire vessel segment treated with balloon angioplasty.Wherever appropriate, it is recommended that the endoprosthesis extend at least 1 cm proximal and distal to the margins of the lesion, and at least 2 cm beyond the proximal and distal margins of the lesion when treating aneurysmal lesions.

• Brand Name: GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS
• Type of Device: 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: sibylle staerk ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 13079201
• MDR Text Key: 285172536
• Report Number: 2017233-2021-02634
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): Y
• Reporter Country Code: NL
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/22/2021
• Device Catalogue Number: BXA055902E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2018
• 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): Hospitalization
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 92 KG