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

Catalog Number	BXB082902A
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Abdominal Pain (1685); Pelvic Pain (4865)
Date of Event	04/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The following was reported to gore: on (b)(6), 2024, the patient underwent treatment for a celiac aneurysm where a two gore® viabahn® vbx balloon expandable endoprosthesis (vbx device) were implanted.The procedure was successful with good overlap between the two vbx devices.They placed a 6x29 and extended with an 8x29 vbx device.The patient had a good outcome.It was reported that the patient was experiencing some pain in the abdomen and in the pelvic.On (b)(6), 2024 the physician went to extend the vbx devices more and it was noticed that the 8x29 vbx device migrated into the left common iliac.The physician confirmed that the vbx device was still open and a distal pulse was felt.The physician left it as endotrash.It was reported that the physician placed a new vbx device to replace the original 8x29 vbx device in the celiac artery.The procedure was concluded without any other reported issue and patient tolerated the procedure.
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.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) 2024, the patient underwent treatment for a celiac aneurysm where a two gore® viabahn® vbx balloon expandable endoprosthesis (vbx device) were implanted.The procedure was successful with good overlap between the two vbx devices.They placed a 6x29 and extended with an 8x29 vbx device.The patient had a good outcome.It was reported that the patient was experiencing some pain in the abdomen and in the pelvic.On (b)(6) 2024, the physician went to extend the vbx devices more and it was noticed that the 8x29 vbx device migrated into the left common iliac.The physician confirmed that the vbx device was still open and a distal pulse was felt.The physician left it as endotrash.It was reported that the physician placed a new vbx device to replace the original 8x29 vbx device in the celiac artery.The procedure was concluded without any other reported issue and patient tolerated the procedure.
Additional Manufacturer Narrative
Section h6 updated to reflect completion of investigation.Manufacturing records were reviewed, and the device met all pre-release specifications.Images were provided to gore for evaluation.Evaluation of the provided images indicated migration of the stent within two months of the index procedure, was confirmed through evaluation of the provided clinical images.Pre-implant images show the celiac artery aneurysm where two vbx devices were reportedly placed, and post-implant images confirm a stent in both the celiac and left common iliac arteries.The reported information indicates endoprosthesis in the left common iliac was left in the patient as ¿endotrash¿, and another vbx device was placed in the original implant location.Further information regarding this event was requested by gore, but no further information has been reported, therefore this investigation is considered complete.Instructions for use (ifu) statements: the vbx device ifu was reviewed with respect to the complaint detail for the applicable region and time period.The following statement from the ifu is applicable to the complaint.Possible adverse events and complications that may occur with the use of this device or in any endovascular procedure and require intervention include but are not limited to: migration.B4: updated description of event.H6: added code b15 as images were provided to review under type of investigation.H6: removed code d16 and added code d15 and d12 under investigation conclusions.

• 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: vanessa rodriguez ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 19347487
• Report Number: 2017233-2024-04949
• Device Sequence Number: 20486587
• Product Code: PRL
• UDI-Device Identifier: 00733132658701
• UDI-Public: 00733132658701
• Combination Product (Y/N): Y
• Initial Reporter State: SC
• 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): 08/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: BXB082902A
• 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: 04/29/2024
• Supplement Date Received by Manufacturer: 07/16/2024
• Initial Report FDA Received Date: 05/17/2024
• Supplement Report FDA Received Date: 08/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 39 YR
• Patient Sex: Female