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

Catalog Number BXA067902E

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

Patient Problem Renal Failure (2041)

Event Date 08/04/2020

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing records indicated the lot met all pre-release manufacturing specifications.The device remains implanted in the patient.Images have been requested and received for evaluation.The investigation is ongoing.Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.

Event Description

On (b)(6) 2020, the patient underwent a branched endovascular aortic repair (bevar) to treat a thoracoabdominal aneurysm type iv with a customized fenestrated / branched stent graft component (cook medical).Three gore® viabahn® vbx balloon expandable endoprostheses (viabahn vbx device) were implanted via a cut-down to the left axillary artery to extend the branches into the left renal artery, the right renal artery and the superior mesenteric artery (sma).All viabahn vbx devices were navigated to their intended locations and deployed without issues.At the end of the procedure all viabahn vbx devices were patent.The patient tolerated the procedure.On (b)(6) 2020, a post-op follow-up computed tomography angiography showed that all viabahn vbx devices were still patent.Reportedly, then the patient went for vacation in turkey.During vacation, on (b)(6) 2020, the patient presented at a hospital in (b)(6), were occlusion of the viabahn vbx devices implanted in the left renal artery and the right renal artery was diagnosed.Permanent impairment of body structure or function was noted.Reportedly renal failure occurred.They performed an intra-atrial catheterization and started hemodialysis.In the beginning of (b)(6) the patient traveled back to germany and presented at another hospital because of the necessity of hemodialysis.On (b)(6) 2020, the patient was transferred to the implanting hospital.On (b)(6) 2020, an endovascular reintervention was performed to treat the occluded viabahn vbx devices implanted in the renal arteries.After a re-cutdown to the left axillary artery they performed several thrombectomies in the left and right renal artery using the indigo system cut8 (penumbra) and the rotarex®s rotational thrombectomy system (bard, straub medical).Reportedly the viabahn vbx device implanted in the left renal artery showed a kink-stenosis.The left renal artery was relined distally with a "6 x 5 mm" gore® viabahn® endoprosthesis with propaten bioactive surface and proximally with a "6 x 58 mm" begraft+ aortic stent graft (bentley) to reline the kinked viabahn vbx device.The right renal artery was relined distally with a "7 x 5 mm" gore® viabahn® endoprosthesis with propaten bioactive surface which was extended proximally with a "6 x 58 mm" begraft+ aortic stent graft (bentley).Reportedly about one third of the parenchym of each kidney could be re-perfused.However, hemodialysis needs to be continued.It was stated that the renal failure is a systemic issue due to prolonged ischemia of both kidneys and the creatinine serum level remains increased.

Manufacturer Narrative

Updated event description: h6-code 213: a review of the manufacturing records indicated the lot met all pre-release manufacturing specification.Dicom imaging series have been provided for investigation.The imaging evaluation states the following: five time-points available for evaluation: pre-implantation chest cta dated (b)(6) 2020, post-implantation abd/pelvis cta¿s dated (b)(6) 2020, intra-operative angiogram dated (b)(6) 2020.There appears to be flow through all visualized implanted devices on the (b)(6) 2020 post-implantation time-points.On the (b)(6) 2020 cta, the stents in the renal arteries, bilaterally, appear to be occluded.Contrast appears to reconstitute distal to the stents in the renal arteries, bilaterally.Comparison axial images from (b)(6) 2020 appear to demonstrate the stents have not changed shape or configuration.Intra-operative angiogram images appear to demonstrate: 13:50:50 ¿ no flow in the stents in the renal arteries, bilaterally.13:57:09 ¿ image appears to show a catheter in the left renal artery, extending distal to the implanted stent.14:11:56 ¿ image appears to show contrast flow in most of the stent in the left renal artery.14:19:02 ¿ image demonstrates a catheter extending distal to the stent in the left renal artery.Contrast appears to show some perfusion of the left kidney.14:26:24 ¿ there appears to be at least one additional stent in the left renal artery.14:30:11 ¿ image has annotations that were labeled at the site on image that appears to be in the left renal artery: 6x58 begraft+.8x5 viabahn.14:35:57 ¿ image appears to show a catheter in the right renal artery.Contrast appears to be showing some perfusion in the right renal artery.14:46:38 ¿ there appears to be contrast flow in most of the stent in the right renal artery.14:59:15 ¿ there appears to be contrast flow, in the right renal artery, through the stent and distally into the right kidney.15:14:11 ¿ image appears to show at least one additional device implanted in the right renal artery.15:16:27 - there appears to be ballooning within the implanted devices in the right renal artery.15:16:58 - image has annotations that were labeled at the site on image that appears to be in the right renal artery: 6x58 begraft+.7x5 viabahn.15:21:31 ¿ final angiogram image appears to show flow throughout the implanted devices including the right and left renal arteries.Two viabahn vbx devices were involved in this event, therefor two manufacturer reports were submitted.The manufacturer report numbers are 2017233-2020-01381 and 2017233-2020-01382.

Event Description

On (b)(6) 2020, the patient underwent a branched endovascular aortic repair (bevar) to treat a thoracoabdominal aneurysm type iv with a customized fenestrated / branched stent graft component (cook medical).Three gore® viabahn® vbx balloon expandable endoprostheses (viabahn vbx device) were implanted via a cut-down to the left axillary artery to extend the branches into the left renal artery, the right renal artery and the superior mesenteric artery (sma).All viabahn vbx devices were navigated to their intended locations and deployed without issues.At the end of the procedure all viabahn vbx devices were patent.The patient tolerated the procedure.On (b)(6) 2020, a post-op follow-up computed tomography angiography showed that all viabahn vbx devices were still patent.Reportedly, then the patient went for vacation in turkey.During vacation, on (b)(6) 2020, the patient presented at a hospital in turkey, were occlusion of the viabahn vbx devices implanted in the left renal artery and the right renal artery was diagnosed.Permanent impairment of body structure or function was noted.Reportedly renal failure occurred.They performed an intra-atrial catheterization and started hemodialysis.In the beginning of september the patient traveled back to germany and presented at another hospital because of the necessity of hemodialysis.On (b)(6) 2020, the patient was transferred to the implanting hospital.On (b)(6) 2020, an endovascular reintervention was performed to treat the occluded viabahn vbx devices implanted in the renal arteries.After a re-cutdown to the left axillary artery they performed several thrombectomies in the left and right renal artery using the indigo system cut8 (penumbra) and the rotarex®s rotational thrombectomy system (bard, straub medical).Reportedly the viabahn vbx device implanted in the left renal artery showed a kink-stenosis.The left renal artery was relined distally with a "6 x 5 mm" gore® viabahn® endoprosthesis with propaten bioactive surface and proximally with a "6 x 58 mm" begraft+ aortic stent graft (bentley) to reline the kinked viabahn vbx device.The right renal artery was relined distally with a "7 x 5 mm" gore® viabahn® endoprosthesis with propaten bioactive surface which was extended proximally with a "6 x 58 mm" begraft+ aortic stent graft (bentley).Reportedly about one third of the parenchym of each kidney could be re-perfused.However, hemodialysis needs to be continued.It was stated that the renal failure is a systemic issue due to prolonged ischemia of both kidneys and the creatinine serum level remains increased.

• Brand Name: GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS
• Type of Device: ILIAC COVERED STENT, ARTERIAL
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 10741184
• MDR Text Key: 213229895
• Report Number: 2017233-2020-01382
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): Y
• 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
• Report Date: 01/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/06/2022
• Device Catalogue Number: BXA067902E
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Disability
• Patient Age: 73 YR
• Patient Weight: 78