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

Model Number BXAL087902A

Device Problems Patient-Device Incompatibility (2682); Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/01/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The following was reported to gore: patient with a very tortuous anatomy received treatment in the hypogastric artery due to an aneurysm.An 8fr sheath was used to advance a gore® viabahn® vbx balloon expandable endoprosthesis (vbx) over a glide advantage wire.From the brachial artery access site, the delivery catheter was being advanced when device became stuck in mid thoracic aorta.Decision was made to withdraw the delivery catheter.The vbx device was retracted over the wire without a long guide sheath present.After the delivery catheter was removed, it was noticed the stent had come off the catheter in mid thoracic aorta.From the groin access, a snare was used to remove the constrained vbx stent.A new gore® viabahn® vbx balloon expandable endoprosthesis was implanted at the intended treatment site with no issues.The patient did not experience any adverse consequences.

Event Description

The following was reported to gore: during treatment of a hypogastric artery, an 8fr sheath was used to advance a gore® viabahn® vbx balloon expandable endoprosthesis (vbx) over a glide advantage wire.Obtained information state the facility did not have a long 8 french shuttle sheath.The physician elected to move forward with the procedure using a short 8 french sheath.As reported, the patient has a very tortuous anatomy.An iliac branch device was deployed via the right groin.From the brachial artery access, the vbx delivery catheter was being advanced when it became stuck mid thoracic aorta.Decision was made to withdraw the delivery catheter over the wire only without a long guide sheath present.After removal of the vbx delivery catheter, it was noticed the stent and balloon were missing.The stent and balloon were still on the wire in the mid thoracic aorta.From the right groin access, a snare was used to remove the vbx stent and balloon.A new gore® viabahn® vbx balloon expandable endoprosthesis was used to complete the procedure.The patient did not experience any adverse consequences.The affected device was discarded at user facility.

Manufacturer Narrative

Instructions for use for gore® viabahn® vbx balloon expandable endoprosthesis (ifu) warnings section state, special care should be taken to ensure that the appropriate size endoprosthesis, compatible sheath and guidewire are selected prior to introduction.Native vessel dimensions must be accurately measured, not estimated.

Manufacturer Narrative

Code 213: review of device manufacturing record history confirmed device met pre-release specifications.An engineering evaluation task was performed and the following summary was reported: the referenced complaint did not have a returned device.The following evaluation is based on information obtained from the event description and communication summary.The manufacturing lot history files were reviewed and did not suggest any abnormalities that might have contributed to the insertion complaint.For the associated balloon lot, it was confirmed that the proximal balloon bond exceeded the specified minimum tensile strength.This suggests it is unlikely that a bond failure led to the detachment of the covered balloon and stent graft.Based on this evaluation, no product design or manufacturing anomalies were detected.

Manufacturer Narrative

H6 code 213: although the device reported in the event was not returned to gore, an engineering evaluation task was performed and the following summary is an update: the referenced complaint did not have a returned device.The following evaluation is based on information obtained from the event description and communication summary.Stent dislodgement of the vbx device may be affected by device profile and manufacturing crush force.Device profile is 100% verified during the vbx manufacturing process.The device history file was reviewed and no anomalies were identified.Crush force is controlled through machine maintenance and calibration.Machine history files were reviewed and no non-routine maintenance was identified.Based on the device evaluation performed, no manufacturing anomalies were identified to which the event could be definitively attributed.

• 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: 9251337
• MDR Text Key: 194021195
• Report Number: 2017233-2019-01093
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 00733132637676
• UDI-Public: 00733132637676
• Combination Product (y/n): N
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/24/2022
• Device Model Number: BXAL087902A
• Device Catalogue Number: BXAL087902A
• Device Lot Number: 20690398
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/29/2019
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 11/08/2019; 12/10/2019; 01/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Weight: 100