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

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/19/2021

Event Type  malfunction  

Manufacturer Narrative

The original received event description includes information about 2 gore® viabahn® vbx balloon expandable endoprostheses cases.The first case (10 mm device) was reported under the medwatch report # 2017233-2021-01677.Due to a misinterpretation of the event description and during an internal review, a second case (8 mm device) had to be opened and reported.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 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

Seven images were provided to gore in pdf-format.The imaging evaluation showed the following: 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." type of investigation code 4119: the serial numbers were not provided, therefore a review of the manufacturing records could not be conducted.Conclusion code 61: the gore® viabahn® vbx balloon expandable endoprosthesis instructions for use (ifu) includes the following instruction: ¿always use an appropriately sized sheath for the implant procedure.It is advisable to use a sheath or guide catheter that is long enough to cross the lesion.Use of a guide sheath or guide catheter minimizes the risk of dislodging the endoprosthesis from the balloon during tracking.¿ and ¿carefully observe the endoprosthesis for stent dislodgement or movement while attempting to withdraw the undeployed stent back through the sheath.¿.

• 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: 12638320
• MDR Text Key: 276590848
• Report Number: 2017233-2021-02471
• 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,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2021
• 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; COOK T BRANCH 4 FENESTRATIONS.
• Patient Age: 74 YR
• Patient Sex: Male