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

Catalog Number BXA105902E

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/19/2021

Event Type  Injury  

Manufacturer Narrative

As the device remains implanted, no further investigation can be performed.Images were made available and it has to be determined if an imaging evaluation can be performed.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

It was reported to gore that patient underwent endovascular treatment for a t-branched case in the celiac trunc with gore® viabahn® vbx balloon expandable endoprostheses (vbx-device).It was stated that it was planned to implant a cook iliac branch device (ibd) plus an extension in the right internal iliac artery with a vbx-device.In addition, a cook t-branch (4 branches) to cover the renal arteries and a vbx-device for the superior mesenteric artery (sma) and the celiac trunk.It was reported that the ibd and the vbx-device were placed in the internal and external iliac arteries as planned.For cannulation of the visceral artery a 16fr steerable sheath with a 23mm tip deflection was used, which ran over a supra core guidewire.The guidewire was placed in the visceral artery and the steerable sheath in the t-branched device for angulation and support.It was stated that the placement of the covered stents in the renal arteries and the sma ran as planned with no difficulties.It was reported that problems arose during the last visceral vessel to be branched, namely the celiac trunk.The t-branch was a bit compromised by the large angulation from the thoracic graft and the access of the celiac trunk which was stenotic, but they were able to cannulate with the supra core guidewire.It was stated that placement with the vbx-device (bxa105902e) went in and over the 16fr steerable sheath with a 180° angulation over the supra core guidewire, but resistance was met when it was tried to go into the branch and into the celiac trunk.A bit pressure was put on the catheter to see if the stent can be forced into the celiac trunk.This was not possible, so the physician decided to retract the vbx-device and go in with a smaller size vbx-device (bxa085902e), to see if it is possible to cannulate the celiac trunk with the smaller vbx-device instead.It was reported that what really happened during retraction of the vbx-device (bxa105902e) was unfortunately not noticed by the physicians before the case was done and they finally looked at the angiography pictures.It was stated that during retraction of the vbx-device (bxa105902e) the stent fell off the catheter and was left in the opening of the celiac trunk.It is important to notice that the physicians have not tried to balloon the stent before retracting the catheter.It is also important to notice that the physicians were not aware at this point that the stent has fallen off the catheter and was left in the celiac trunk.It was reported that the physicians proceeded as planned and tried to change the vbx-device (bxa105902e) to a smaller vbx-device (bxa085902e).Obviously, they were not able to place this stent either, since the smaller vbx-device (bxa085902e) was forced into the bigger ones which they could not see.It was decided to retract the smaller vbx-device (bxa085902e) too and just leave the celiac trunk unstented.It will be staged on a later occasion.It was stated when retracting the smaller vbx-device (bxa085902e) from the celiac trunk, the bigger vbx-device was left in the opening of the t-branch/ celiac trunk.At this point the physicians immediately saw that the stent was left in the trunk not dilatated.It was reported that the stent was left too far out of the celiac trunk for them to try to balloon it on site, so they were forced to retract the vbx-device from the celiac trunk with a snare and to pull it back to the common iliac artery and to balloon it there.It was stated that after the vbx-device (bxa085902e) was placed in the iliac artery, a last angiography was run, and the procedure finished.Reportedly, the plan going forward with the patient, is to do a new intervention from the right arm.The aim is to try to cannulate the vbx-device (bxa105902e) and balloon it on place.

Manufacturer Narrative

Investigation: it was stated that resistance was met when it was tried to advance the first gore® viabahn® vbx balloon expandable endoprosthesis (vbx device) into the celiac trunk.Force was applied on the device catheter without success.The physician decided to retract the 10 mm device and decided to use a smaller 8 mm vbx device (bxa085902e; (b)(4); manufacturer report number 2017233-2021-02471) without a sheath.It was realized on the final angiography images that the undeployed 10 mm endoprosthesis displaced from the catheter and remained in the opening of the celiac trunk.Since it was not realized during the procedure that the 10 mm device remained in the celiac trunk, the physician proceeded as planned and unsuccessfully tried to advance the 8 mm device.This was not possible since the celiac trunk was blocked by the remaining 10 mm device.It was not possible to retract the 8 mm device and the endoprosthesis was also displaced from the catheter.Therefore, it was decided to pull the device back into the common iliac artery (cia) with a snare.The device was fully ballooned and remained in the cia.On a later date the celiac trunk was canulated via arm access and stented with a new vbx device.The 10 mm device was removed out of the patient by using a snare catheter.Imaging evaluation: 3:06pm - there appears to be an undeployed vbx within the celiac artery.3:10pm - there appears to be an undeployed vbx within the celiac artery.There does not appear to be a wire within this undeployed vbx.4:15pm - there appears to be a vbx deployed within the common iliac a previous implanted endograft.Unable to confirm specific event details and deployment sequences using the available images.Images contain no patient demographic information.The pdf provided contained the images above, but these appear to be secondary captures and do not provide a full review.No pre-deployment images are available.Unable to determine the diameters or vessel condition prior or during deployment.Unable to evaluate the alignment of the graft¿s portal to the celiac osteum."the images received cannot be used to perform a full imaging evaluation.The extent and accuracy of the reviewers¿ observations and findings may be limited due to the completeness, format and/or quality of the available images.Gore cannot make conclusions or guarantee the images received are accurate or lack alteration.Therefore, gore cannot guarantee that all key findings have been captured or that the findings are accurate." investigation conclusion: there was no device return associated with this complaint.A review of the manufacturing records could not be performed as no serial number was provided.A root cause for the failure to advance the vbx device could not be confirmed.As a result of a failure to advance the vbx device was withdrawn.During withdrawal of the vbx device the endoprosthesis dislodged from the delivery catheter.A root cause for stent dislodgement could not be confirmed.The ifu recommends that the physician carefully observe the endoprosthesis for stent dislodgement while attempting to withdraw the undeployed stent back through the sheath.It was stated in the complaint description that the physician was unaware that the endoprosthesis had been dislodged during removal of the first vbx device and proceeded as planned to advance a second vbx device.The failure to observe and address the displaced stent from the first vbx device contributed to complications with the second vbx device (manufacturer report number 2017233-2021-02471).

Event Description

It was reported that the patient presented with a thoracoabdominal aneurysm that was intended to be treated with a zenith® t-branch® thoracoabdominal endovascular graft and a zenith® branch endovascular graft- iliac bifurcation.Gore® viabahn® vbx balloon expandable endoprostheses were intended to be used as side branches.It was stated that the zenith® devices and the gore® viabahn® vbx balloon expandable endoprostheses in the renal arteries and the superior mesenteric artery (sma) were deployed successfully.A 10 mm gore® viabahn® vbx balloon expandable endoprosthesis (bxa105902e) was intended to be placed in the celiac trunk that appeared to be stenotic, but which was possible to be cannulated with a supra core guidewire.Additionally, it was mentioned that the t-branch® was compromised due to the large angulation of a previously implanted thoracic endoprosthesis.The 10 mm device was advanced through a 16fr sheath with a 180° angulation over the guidewire.It was stated that resistance was met when it was tried to advance the device into the branch and into the celiac trunk.Force was applied on the device catheter without success.The physician decided to retract the 10 mm device and decided to use a smaller 8 mm gore® viabahn® vbx balloon expandable endoprosthesis (bxa085902e) without a sheath.It was realized on the final angiography images that the undeployed 10 mm endoprosthesis displaced from the catheter and remained in the opening of the celiac trunk.Since it was not realized during the procedure that the 10 mm device remained in the celiac trunk, the physician proceeded as planned and unsuccessfully tried to advance the 8 mm device.This was not possible since the celiac trunk was blocked by the remaining 10 mm device.The 8 mm device was not possible to be retracted and was also displaced from the catheter.Therefore, it was decided to pull the device back into the common iliac artery (cia) with a snare.The device was fully ballooned and remained in the cia.On a later date the celiac trunk was canulated via arm access and stented with a new gore® viabahn® vbx balloon expandable endoprosthesis.The 10 mm device was removed out of the patient by using a snare catheter.The patient tolerated the procedure without reported adverse events to the patient.

Manufacturer Narrative

H6 - code 3221: review of device manufacturing record history could not be conducted as device lot/serial number was not provided.The device was discarded at user facility.Therefore, direct product analysis could not be performed.Patient weight, co-morbidities and medications were requested but not made available.B1: update to adverse event and product malfunction.D4: catalog number was entered based on device size provided (no lot/serial number).G2: report source, additional selection.H1: type of reportable event updated to 'serious injury.'.

• 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
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: gunter marte ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 11332663
• MDR Text Key: 239177805
• Report Number: 2017233-2021-01677
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): Y
• Reporter Country Code: DA
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/03/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: BXA105902E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/20/2021
• Initial Date FDA Received: 02/16/2021
• Supplement Dates Manufacturer Received: 10/19/2021; 10/19/2021
• Supplement Dates FDA Received: 11/17/2021; 02/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: COOK T BRANCH 4 FENESTRATIONS.
• Patient Age: 74 YR
• Patient Sex: Male