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	11/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The following was reported to gore: on (b)(6) 2022, the patient underwent treatment in the internal iliac artery for an unknown etiology using two gore® viabahn® vbx balloon expandable endoprosthesis devices.It was reported the physician accesses the treatment area using an unknown sheath.In route to the target treatment area, the vbx device detached from the catheter, necessitating deployed in the common femoral artery.A surgical balloon was used to expand and implant the device in the unintended location.The physician then attempted to advance another vbx device.This device reached the target treatment area but also became detached from the catheter.A surgical balloon was used to implant this device as well.The physicians stated his suspected cause of both the devices separating from the delivery system catheters is unknown.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
Engineering evaluation: reported dislodgment of the endoprosthesis from the delivery balloon catheter could not be independently confirmed in this investigation as no items, including product or clinical images, were returned for a direct assessment of product performance.Moreover, additional details requested from the field, including accessory sheath size/model, treatment etiology, and the physician¿s opinion concerning suspected cause or contributing factors to the event, were unknown.Therefore, the cause of the reported dislodgement could not be established with the available information.

• 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: marcos ayala ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15920616
• Report Number: 2017233-2022-03541
• Device Sequence Number: 4459862
• Product Code: PRL
• UDI-Device Identifier: 00733132637744
• UDI-Public: 00733132637744
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P160021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2022

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: 09/09/2025
• 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: 11/08/2022
• Supplement Date Received by Manufacturer: 11/08/2022
• Initial Report FDA Received Date: 12/05/2022
• Supplement Report FDA Received Date: 12/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Hospitalization
• Patient Sex: Unknown