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

Catalog Number BXA065902E

Device Problem Obstruction of Flow (2423)

Patient Problems Renal Failure (2041); Hypovolemia (2243); Blood Loss (2597)

Event Date 08/01/2019

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.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.During the procedure an estimated blood loos of 800 ml occurred.One blood transfusion was needed after the surgery and one more the next day.On (b)(6) 2019, a planned routine follow-up control computed tomography was performed.It was reported that imaging showed that the viabahn® vbx device implanted in the right renal artery was thrombosed and that the right kidney had already atrophy.The patient is asymptomatic, therefore the date of the occlusion of the renal artery remains unknown.It was stated, that this is a permanent fact, the kidney cannot be re-perfused, there is no therapy available.Thus, permanent impairment of body structure or function was noted.

Manufacturer Narrative

B5: updated event description: removal of language "according to the database entries of the study".H6-code 3331: the investigation involved the analysis of relevant production records in view of supporting the identification of possible causes for the adverse event.H6-code 213: a review of the manufacturing records indicated the device met pre-release specifications.H6-code 3221: the device was not returned for investigation.It remains implanted in the patient.Review and analysis of all available information fails to indicate a potential root cause of the incident as reported to gore.

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.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.During the procedure an estimated blood loos of 800 ml occurred.One blood transfusion was needed after the surgery and one more the next day.On (b)(6), 2019, a planned routine follow-up control computed tomography was performed.It was reported that imaging showed that the viabahn® vbx device implanted in the right renal artery was thrombosed and that the right kidney had already atrophy.The patient is asymptomatic, therefore the date of the occlusion of the renal artery remains unknown.It was stated, that this is a permanent fact, the kidney cannot be re-perfused, there is no therapy available.Thus, permanent impairment of body structure or function was noted.

Manufacturer Narrative

H6-code 4315: the investigation findings did not lead to a clear conclusion about the cause of the reported adverse event.

Manufacturer Narrative

Previously reported h6-code 2597 and h6-code 2243 are no longer applicable.The issue is processed with mfr report #2017233-2019-00925, gore event (b)(4).

• 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: 9121991
• MDR Text Key: 160125953
• Report Number: 2017233-2019-00924
• 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: 11/11/2019

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
• Patient Outcome(s): Hospitalization; Disability
• Patient Age: 78 YR
• Patient Weight: 81