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

Catalog Number	BXB087902A
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The following was reported to gore: during an abdominal aneurysm procedure, two gore® viabahn® vbx balloon expandable endoprostheses (vbx devices) were implanted to treat the aorto-iliac arteries using a kissing technique.As reported, the vbx devices reached the intended treatment site and both were deployed with no issues.However, when the vbx balloon catheter was removed from the patient's left side access, it was noticed the balloon covering had become detached on one end.The removed balloon was confirmed to have no missing pieces.It is unknown which balloon was partially detached as same sized vbx devices were used.The patient did not experience any adverse consequences.
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.Two vbx devices were implanted during the same procedure.One of the two same-sized device had reported balloon partial detachment issues at removal.Gore is unable to determine which device / device component is involved in a reportable adverse event, and the devices are of the same device device type.The second device information is: l/s #28162287; udi #(b)(4); catalog #bxb087902a.H6 - code c19: review of device manufacturing record history confirmed devices met pre-release specifications.H6 - code c21: anticipated device components return; results pending investigation completion.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
D8/d9: device components were returned to gore.As it was unknown which device and component were implanted in the left access side, both were evaluated with the following results: mpdcase-1: engineering evaluation confirmed the primary reported failure mode, related to broken components, as the balloon cover was observed detached from its distal tie down location and shifted proximally.The direction of cover displacement does not support detachment occurred during withdrawal though an exact mechanism could not be confirmed.Possible end tie film used for balloon cover bonding onto the catheter during manufacturing was identified at the distal tip, and no evidence of a manufacturing-related deficiency was observed with the available information.Moreover, this investigation could not independently confirm potential unintended interactions with other devices and/or accessories or any subsequent manipulation that may have compromised the integrity of the distal tie down.The root cause of the confirmed component detachment could not be established following evaluation of the returned device.Mpdcase-2: the reported primary failure mode, related to broken components, could not be confirmed in the device evaluation.Possible loose distal end film was observed attached at the distal tip with some shifting of the balloon cover in the distal direction.However, no component separation was identified as the balloon cover and tie down locations appeared intact.The root cause of the loose material observed at the distal tip could not be established with the available information, including device evaluation.

• 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: genevieve begay ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 19529380
• Report Number: 2017233-2024-05035
• Device Sequence Number: 7483497
• Product Code: PRL
• UDI-Device Identifier: 00733132658763
• UDI-Public: 00733132658763
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P160021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 07/30/2024

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 Catalogue Number: BXB087902A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2024
• Supplement Date Received by Manufacturer: 07/30/2024
• Initial Report FDA Received Date: 06/13/2024
• Supplement Report FDA Received Date: 07/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2023
• 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: 76 YR
• Patient Sex: Male
• Patient Weight: 57 KG