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

Catalog Number BXA107902E

Device Problems Break (1069); Retraction Problem (1536); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/14/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).The endoprosthesis remains implanted in the patient.The broken delivery catheter was returned to gore for investigation.A review of the manufacturing records indicated the device met pre-release specifications.Investigation of the returned delivery catheter is ongoing and results are not yet available.

Event Description

It was reported, that the patient underwent a branched endovascular aneurysm repair (bevar) due to an aortic aneurysm.It was treated with a branched vascular graft (jotec-cryolife).To extend the branch into the superior mesenteric artery a gore® viabahn® vbx balloon expandable endoprosthesis was used.Reportedly, access was gained from the brachial artery of the left arm.After the superior mesenteric artery was cannulated, an 8fr flexor introducer sheath (cook medical) was inserted.It was stated that the gore® viabahn® vbx balloon expandable endoprosthesis was unboxed and flushed properly.Then the viabahn® vbx endoprosthesis was advanced over a stiff guide wire (lunderquist).Reportedly a slight friction was experienced when the viabahn® vbx endoprosthesis was advanced through the introducer sheath to the intended landing zone.It was stated that then the viabahn® vbx endoprosthesis was successfully deployed.Reportedly, during withdrawel of the delivery catheter, resistance was encountered.It was stated, that they pulled hard, which caused the balloon to get stuck inside the introducer sheath.At another attempt to pull, the delivery catheter broke at the hub of the delivery system, leaving the balloon stuck inside the introducer sheath.It was reported, that eventually they withdrew the remaining part of the delivery catheter with the balloon inside the introducer sheath together with the introducer sheath in a tandem.Another introducer sheath was used to complete the intervention.It was stated, that no injury of the patient occurred.

Manufacturer Narrative

H6-code 4117: the endoprosthesis remains implanted in the patient.The broken delivery catheter was returned to gore for investigation.H6-code 213: the broken delivery catheter was returned to gore for investigation.The engineering evaluation states the following: the device was identified to be a 10 mm x 79 mm x 1350 mm configuration, which matches the event description.The gore® viabahn® vbx balloon expandable delivery system was returned with the hub detached and the catheter stuck within a non-gore introducer sheath.The device arrived with an introducer sheath; however, because this is not a gore product it was not evaluated.The delivery catheter displayed necking within the first centimeter from the proximal end of the delivery system.The delivery catheter lot met specifications for tensile strength.The catheter of the vbx delivery system is 100% inspected at the end of the manufacturing process for any mechanical damage, including necking.Any devices with mechanical damage are rejected.The manufacturing process output of device profile can contribute to insertion difficulties.Device profile is 100% inspected during the manufacturing process.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: 9700077
• MDR Text Key: 197840292
• Report Number: 2017233-2020-00092
• 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: distributor
• Type of Report: Initial,Followup
• Report Date: 02/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/11/2022
• Device Catalogue Number: BXA107902E
• Device Lot Number: 21193725
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2020
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8FR FLEXOR INTRODUCER SHEATH (COOK MEDICAL)
• Patient Age: 67 YR