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

Catalog Number BXA082901B

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/22/2020

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing records for the device verified the lot met all pre-release specifications.

Event Description

The following information was reported to gore: on (b)(6) 2020 a patient was undergoing treatment of an internal iliac artery aneurysm with a gore® viabahn® vbx balloon expandable endoprosthesis.The device was advanced through a long arrow 7fr sheath to the target region.However when the device was pushed out of the end of the sheath it could not be advanced to the target landing zone, so it was not deployed.An attempt to pull the device back into the sheath was made, despite being warned that this is not according to ifu.When pulling the device back through the sheath it came off the delivery catheter.The catheter was removed from the patient with the undeployed device remaining in the patient.The device was then secured in the sac with a combination of a begraft and a gore® viabahn® endoprosthesis with propaten bioactive surface.The patient was treated successfully and did well following the procedure.

Manufacturer Narrative

H.6 method code 2 updated.H.6.Results code 2: 213: 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.

Manufacturer Narrative

H.6.Conclusion code 2: added.

Manufacturer Narrative

Conclusion code 1: updated.

• 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: 9729490
• MDR Text Key: 195448814
• Report Number: 2017233-2020-00102
• 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: 05/29/2020

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: 06/23/2022
• Device Catalogue Number: BXA082901B
• Device Lot Number: 20967984
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/19/2020
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 04/27/2020; 05/29/2020; 05/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 83 YR