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

Model Number	BXA115902A
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2023
Type of Reportable Event	Malfunction
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.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 was reported to gore: on (b)(6) 2023, a patient presented with in-stent re-stenosis of medtronic visi-pro stents in an external iliac artery and underwent treatment utilizing four gore® viabahn® vbx balloon expandable endoprostheses (vbx) devices.The physician gained femoral access and advanced a vbx device through an 8fr x 23 cordis brite tip¿ sheath.The device was unable to be advanced to the intended location, so the physician decided to withdraw the device.During withdrawal, the vbx device became caught on a previously implanted stent and dislodged from the delivery catheter.The vbx balloon delivery catheter was removed from the patient, and a 4 x 60 medtronic evercross pta balloon was advanced into the undeployed vbx device.After the vbx device was initially expanded, the physician upsized to a 7x60 medtronic evercross pta balloon and optimally deployed the vbx device within the external iliac artery.The dislodged vbx device was deployed within an intended area of treatment, preserving the hypogastric artery.Three additional vbx devices were used to complete the procedure with no incidence.The patient tolerated the procedure with no reported harm.
Additional Manufacturer Narrative
A review of manufacturing records verified that the lot involved in this complaint met all pre-release specifications.Images were returned for evaluation: an imaging evaluation of the returned clinical items was performed by an imaging specialist.The items received could not be used to perform a full imaging evaluation because they did not meet the dicom standard.Therefore, the extent and accuracy of the observations and findings were limited due to the completeness, format and/or quality of the items provided for review.Evaluation of the reported failure mode could not be conducted with the items returned for review.The following was noted during evaluation: there appears to be at least one deployed device present on the left side.Unable to identify deployment location in relation to a branch or vessel due to lack of contrast.Investigation conclusion code d15: the reported stent dislodgement during withdrawal could not be independently confirmed with the available information, including imaging evaluation.Investigation conclusion code d1002: reported event details indicate the vbx device became caught on a previously implanted stent during withdrawal, and there was subsequent stent dislodgement observed.Therefore, the root cause of the stent dislodgement is consistent with an unintended device interaction resulting in procedural difficulty as 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: kaitlin barnash ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 16632036
• Report Number: 2017233-2023-03824
• Device Sequence Number: 14786049
• Product Code: PRL
• UDI-Device Identifier: 00733132637744
• UDI-Public: 00733132637744
• 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: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/11/2026
• Device Model Number: BXA115902A
• Device Catalogue Number: BXA115902A
• 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: 03/06/2023
• Supplement Date Received by Manufacturer: 03/06/2023
• Initial Report FDA Received Date: 03/28/2023
• Supplement Report FDA Received Date: 04/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2023
• 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
• Patient Age: 72 YR
• Patient Sex: Female