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

Catalog Number BXA085902J

Device Problems Material Separation (1562); Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)

Patient Problem Aneurysm (1708)

Event Date 08/23/2019

Event Type  malfunction  

Manufacturer Narrative

Additional manufacturer narrative: review of the manufacturing records verified that the lot met release requirements.The investigation is ongoing.

Event Description

The following was reported to gore: on (b)(6) 2019, this patient underwent an endovascular repair for abdominal aortic aneurysm using chimney technique.It was planned to implant a gore® viabahn® vbx balloon expandable endoprosthesis (vbx device) in the left renal artery as a chimney device.Access to the left renal artery was obtained from the left brachial artery.The delivery catheter of the vbx device was advanced, however, the catheter stuck inside the sheath.The catheter was removed from the patient, and it was confirmed that there was no issue on the device.The y-connector of the sheath was changed to a hemostatic valve, and another attempt to advance the vbx device was attempted.However, the catheter again stuck inside the sheath.Also, during advancement of the catheter, fluoroscopy showed that the constrained endoprosthesis and the balloon had a position gap.It was decided to remove the catheter, and strong resistance was noted.The catheter was pulled forcefully, and the delivery catheter broken at around 1 cm distal to the constrained endoprosthesis.As the breakage of the catheter occurred near the hub end of the sheath during withdrawal of the catheter, the physician was able to remove the broken end of the catheter from the patient by hand.

Manufacturer Narrative

Additional manufacturer narrative: examination of the returned device revealed the following: the gore® viabahn® vbx balloon expandable endoprosthesis was returned as two separate pieces.The delivery catheter was observed to have catheter damage at 57 cm, 59.5 to 60.5 cm, and 61.5 to 62.5 cm.The delivery catheter was necked at 125.5 to 127.5 cm where a separation of the catheter was observed.The separated section of the delivery system included the dislodged endprosthesis, balloon, balloon cover, and a portion of the delivery system catheter.The proximal most ring of the endoprosthesis was observed to have a bent ring apex.The second most distal ring was observed to have flaring on one end.The event description described the attempted insertion, removal, and reinsertion of the gore® viabahn® vbx balloon expandable endoprosthesis ¿the catheter was removed from the patient, and it was confirmed that there was no issue with the device.The y-connector of the cook shuttle sheath was changed to a hemostatic valve, and another attempt to advance the vbx device delivery catheter was made.However, the catheter again stuck inside the sheath¿.The gore® viabahn® vbx balloon expandable endoprosthesis should have been discarded per the gore® viabahn® vbx balloon expandable endoprosthesis ifu warnings section instead of attempting to be reinserted: 'do not withdraw the gore® viabahn® vbx balloon expandable endoprosthesis back into the introducer sheath once the endoprosthesis is fully introduced.Withdrawing the gore® viabahn® vbx balloon expandable endoprosthesis back into the sheath can cause dislocation and / or damage to the endoprosthesis, premature deployment, deployment failure, and / or catheter separation.If removal prior to deployment is necessary, withdraw the gore® viabahn® vbx balloon expandable endoprosthesis to a position close to but not into the introducer sheath.Both the gore® viabahn® vbx balloon expandable endoprosthesis and introducer sheath can then be removed in tandem.After removal, do not reuse the gore® viabahn® vbx balloon expandable endoprosthesis or introducer sheath'.

Manufacturer Narrative

Corrected data: h6.Conclusions code 1.

• 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: 9088414
• MDR Text Key: 159193587
• Report Number: 2017233-2019-00875
• Device Sequence Number: 1
• Product Code: NIO
• 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: 12/11/2019

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: 07/29/2021
• Device Catalogue Number: BXA085902J
• Device Lot Number: 18527420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/19/2019
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 10/10/2019; 10/16/2019; 12/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 70 YR