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

Catalog Number	BXA115902A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Perforation of Vessels (2135)
Date of Event	10/08/2024
Type of Reportable Event	Death
Event or Problem Description
The following information was reported to gore: on (b)(6) 2024, gore® viabahn® vbx balloon expandable endoprosthesis (vbx devices) were used in an endovascular procedure to treat highly calcified aortoiliac arteries.It was reported the patient was not a surgical candidate due to their condition at the time of the event.The physician reported the patient's arteries were so heavily calcified vbx devices were implanted in the aortic bifurcation and right iliac artery.During the procedure the right iliac artery ruptured with blood loss that required 4 units of prbc's intravenously.Reportedly, more vbx device(s) and possibly a viabahn device that lined a vbx device were implanted to control the rupture and bleeding.The patient tolerated procedure.The fsa was not present for event and will obtain more information.Patient symptom code 2203-a: other used to capture vessel rupture, blood loss, and blood transfusion.
Additional Manufacturer Narrative
Device serial number requested, and unavailable at this time.The device remains implanted, consequently, a direct product analysis is not possible.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
On (b)(6) 2024, a patient underwent an endovascular procedure for aortoiliac occlusion where six gore® viabahn® vbx balloon expandable endoprosthesis (vbx device) devices were used.It was reported the vbx devices were implanted in the aortic bifurcation and right iliac artery.During the procedure the right iliac artery ruptured.The patient required 4 units of packed red blood cells (prbcs) intravenously due to blood loss.It is suspected the plaque being pushed up against the aortoiliac bifurcation could have caused the rupture.It is unknown which vbx device was implanted in the right iliac artery.Reportedly, additional vbx devices were implanted to control the rupture and bleeding.Reportedly, the patient was very ill and was not a surgical candidate due to their condition at the time of the event.It was reported there was concern about rupture risk prior to stent placement due to the heavily calcified vessels.The patient expired a few days after the procedure.
Additional Manufacturer Narrative
A1, a2, a3: added patient information.B2: additional information made this event a reportable death.Added patient death date as few days after implant date.Exact date unknown.B4: updated event description.D4: added device information for one of the six vbx devices used.It is unknown which of the vbx device is associated with the vessel rupture, bleeding, and death.The other devices used in the procedure are.(b)(6) (bxa105902a), (b)(6) (bxa103902a), (b)(6) (bxa113902a), (b)(6) (bxa112902a), (b)(6) (bxa112902a).H1: updated reportable event type to death.H6: add health effect - impact code - f02 - death.
Additional Manufacturer Narrative
Updated h6 evaluation codes - to reflect investigation findings.A review of the manufacturing records for all six devices used in the procedure indicated the lots met pre-release manufacturing specification.28668422 (bxa115902a), 28207542 (bxa105902a), 28062992 (bxa103902a), 28651283 (bxa113902a), 28355162 (bxa112902a), 28998100 (bxa112902a).This complaint was initiated based on information received from the field.The available information reported in the complaint does not reasonably suggest a potential malfunction or product packaging and/or labeling issue has occurred.Neither clinical images enabling direct assessment of product performance nor the product itself were returned for evaluation, and the cause could not be established with the available information; therefore, this investigation is complete.

• 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: amy mckeown ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 20539077
• Report Number: 2017233-2024-05441
• Device Sequence Number: 6681784
• Product Code: PRL
• UDI-Device Identifier: 00733132637744
• UDI-Public: 00733132637744
• Combination Product (Y/N): Y
• Initial Reporter State: LA
• 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,Followup
• Report Date (Section B): 12/12/2024

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?: No
• Operator of Device: Health Professional
• 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: 10/09/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 10/25/2024
• Supplement Report FDA Received Date: 12/03/2024; 12/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Death; Other
• Patient Age: 76 YR
• Patient Sex: Female