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

Catalog Number BXA082902E

Device Problems Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923); Physical Resistance/Sticking (4012)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/03/2021

Event Type  malfunction  

Event Description

The patient presented with an abdominal aortic aneurysm that was treated with an endograft (cook medical) during a fenestrated endovascular aortic repair.A gore® viabahn® vbx balloon expandable endoprosthesis was used as a branch device to treat the left renal artery.Access was gained from the groin.They stated that they felt extreme high resistance when advancing the device (sn (b)(4)) through a 7fr aptus endosystems tourguide steerable sheath.Reportedly, high force was required to advance the device over the ostium into the renal artery.The physician stated that at this point xray imaging showed that the endoprosthesis dislodged and bunched on the balloon and eventually separated from the delivery catheter.They reported that they could not remove the endoprosthesis from the patient.The endoprosthesis remains in the aneurysmal sac.They then changed to another introducer sheath (medtronic) to advance another gore® viabahn® vbx balloon expandable endoprosthesis (sn (b)(4)) to the left renal artery.Reportedly, during advancement apparently the endoprosthesis loosened from the balloon but they managed to withdraw the endoprosthesis together with the delivery catheter from the patient.Another gore® viabahn® vbx balloon expandable endoprosthesis (sn (b)(4)) was used to complete the procedure successfully.Reportedly the patient is doing well.

Manufacturer Narrative

Patient height: 181 cm.The year of birth of the patient is (b)(6).(b)(6) was used as a best estimate for the date of birth.(b)(4).Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.

Manufacturer Narrative

H6-code 213: two screenshots of the case have been provided for evaluation.Several requests were emailed to the physician to provide the dicom imaging series of the case.The requests remained unanswered.An imaging evaluation was performed based on the event description and the provided screenshots.The imaging evaluation summary states the following: the images received cannot be used to perform a full imaging evaluation because they do not meet the dicom standard and the image quality is poor.The extent and accuracy of the observations and findings may be limited due to the completeness, format and/or quality of the images provided for review.Gore cannot guarantee the images provided are complete, accurate or lack alteration.Therefore, gore cannot guarantee all key findings have been captured or that the findings are accurate.- the images indicate the tourguide steerable sheath being used with ~90 degrees of angulation.- there is no evidence of a device being delivered, pre-deployment or deployment.- there appears to be a vbx stent deployed but unable to ascertain its location.- no guide wire appears to be within the left renal artery.Two devices are involved in this incident, therefore two reports have been submitted: manufacturer report number 2017233-2021-02587.

Manufacturer Narrative

H6: code 4117 and 213: the device dislodged and could not be retrieved from the patient.It remains in the aneurysmal sac.Therefore, a product evaluation could not be performed.The cause of the reported failure mode of covered stent displacement or removal from delivery system during insertion, could not be established with the information provided, including evaluation of the returned images.It was reported in the complaint description that the physician felt extreme high resistance when advancing the vbx device through the sheath.Reportedly, high force was required to advance the device over the ostium into the renal artery.There is a reasonably foreseeable misuse associated with stent migration (including endoprosthesis displacement or dislodgement), related to using too high of a force when advancing the delivery catheter.Contribution of this foreseeable misuse to the endoprosthesis being displaced on the delivery catheter during advancement could not be established, as it could not be confirmed whether the force applied was too high.

Manufacturer Narrative

Section h6: added further applicable codes.H6: codes 22 and 4315 and 61: conclusion: it was reported to gore that the physician felt extreme high resistance when advancing the vbx device through the introducer sheath.Reportedly, also high force was required to advance the vbx device over the ostium into the renal artery.There is a reasonably foreseeable misuse associated with stent migration (including endoprosthesis displacement or dislodgement), related to using high force when advancing the delivery catheter.The cause of reported stent displacement or dislodgement from the delivery catheter is consistent with a reasonably foreseeable misuse related to the application of force to further advancement after meeting resistance.The instructions for use of the gore® viabahn® vbx balloon expandable endoprosthesis recommends that if excessive resistance is felt, the delivery catheter and sheath be removed together as a unit: introduction and positioning of the gore® viabahn® vbx balloon expandable endoprosthesis: with the delivery catheter as straight as possible, insert the guidewire into the tip of the delivery catheter while supporting the delivery catheter and the endoprosthesis.Carefully advance the endoprosthesis in small increments (approximately 0.5 cm) over the guidewire, through the hemostasis valve and introducer sheath, and into the access vessel.Note: if excessive resistance is felt as the gore® viabahn® vbx balloon expandable endoprosthesis is introduced through the hemostasis valve, remove and inspect the delivery catheter for damage.Do not reuse the gore® viabahn® vbx balloon expandable endoprosthesis if damaged or if the covered stent is fluoroscopically observed to be displaced relative to the radiopaque markers on the delivery catheter.Ensure a compatible introducer sheath size (table 1) is used, and that the introducer sheath is free of kinks.Do not insert the shrink sleeve or the hub assembly into the introducer sheath.Using fluoroscopic guidance, advance the delivery catheter over the guidewire via the angiographic sheath.Advance cautiously, especially if resistance is felt.If excessive resistance is felt, remove the delivery catheter and sheath together as a unit.

• 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: sibylle staerk ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12922635
• MDR Text Key: 281669637
• Report Number: 2017233-2021-02588
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): Y
• Reporter Country Code: AU
• 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,Followup,Followup
• Report Date: 06/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/21/2024
• Device Catalogue Number: BXA082902E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2021
• 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
• Patient Outcome(s): Hospitalization
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 91 KG