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

Catalog Number BXA065902E

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypovolemia (2243); Blood Loss (2597)

Event Date 02/13/2019

Event Type  Injury  

Manufacturer Narrative

The device remains implanted in the patient.The device remains implanted in the patient.The delivery system was not returned for investigation.The device remains implanted in the patient.Results pending completion of review of manufacturing records.

Event Description

According to the database entries of the study the patient presented with a thoracoabdominal aneurysm iv.On (b)(6) 2019, during endovascular intervention, the aortic aneurysm was treated with an unknown fenestrated / branched stent graft component.Access was gained by axillary cut-down.For visceral perfusion a gore® viabahn® vbx balloon expandable endoprosthesis was implanted in the superior mesenteric artery, the left renal artery and the right renal artery.During the procedure an estimated blood loos of 800 ml occurred.The viabahn® vbx devices were navigated to their intended location and deployed without issues.At the end of the procedure all viabahn® vbx devices were patent.It was reported that one blood transfusion was needed after the surgery and one more the next day.

Manufacturer Narrative

B3: updated date of event: (b)(6) 2019.D10: the devices remain implanted in the patient.H3: the devices remain implanted in the patient.D11: the reported blood loss is procedure related.There is no association with a vessel or a device.Consequently, all concomitant gore device used during the procedure are provided with d11: di 00733132620913 : lot 17570198, catalog bxa093902e.Di 00733132636853 : lot 18499497, catalog bxa097902e.H6-code 4117: the delivery systems were not returned for investigation.The devices remain implanted in the patient.H6-code 213: a review of the manufacturing records indicated the device, lot 18420185, met pre-release specifications.H6-code 3233: results pending completion of review of manufacturing records, lot 17570198 and lot 18499497.

Event Description

The patient presented with a thoracoabdominal aneurysm iv.On (b)(6), 2019, during endovascular intervention, the aortic aneurysm was treated with an unknown fenestrated / branched stent graft component.Access was gained by axillary cut-down.For visceral perfusion a gore® viabahn® vbx balloon expandable endoprosthesis was implanted in the superior mesenteric artery, the left renal artery and the right renal artery.During the procedure an estimated blood loos of 800 ml occurred.The viabahn® vbx devices were navigated to their intended location and deployed without issues.At the end of the procedure all viabahn® vbx devices were patent.It was reported that one blood transfusion was needed after the surgery and one more the next day.The user reported to gore that the reported blood loss was procedure related.They cannot associate the blood loss to a specific vessel or a specific device.

Manufacturer Narrative

B5: updated event description.H6-code 3331: the investigation involved the analysis of relevant production records of the three gore devices used during the procedure in view of supporting the identification of possible causes for the adverse event.H6-code 213: a review of the manufacturing records indicated the devices met pre-release specifications.

Manufacturer Narrative

H6-code 4311: correction: the adverse event was related to the procedure.

• Brand Name: GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9122955
• MDR Text Key: 160173503
• Report Number: 2017233-2019-00925
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/19/2021
• Device Catalogue Number: BXA065902E
• Device Lot Number: 18420185
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DI00733132620913DI00733132636853
• Patient Outcome(s): Hospitalization
• Patient Age: 78 YR
• Patient Weight: 81