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

Catalog Number BXA115902A

Device Problems Difficult to Open or Close (2921); Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/05/2019

Event Type  malfunction  

Manufacturer Narrative

Review of device manufacturing record history is currently being reviewed.Device components were returned and is currently under review.

Event Description

The following was reported to gore: during an abdominal aorta aneurysm procedure and iliac branch treatment, a gore® viabahn® vbx balloon expandable endoprosthesis (vbx) was implanted to extend a gore® excluder® iliac branch endoprosthesis (ibe) distally into the internal iliac artery.Contralateral access was from the common femoral artery.As reported, the patient has a tortuous anatomy.Using an 11fr gore® dryseal flex introducer sheath, the vbx device was advanced over a lunderquist 260 cm stiff wire.The physician encountered pushability issues with the dryseal sheath and switched to a 12fr medtronic sheath.Advancement difficulty was still experienced but the vbx device was able to go through the ibe limb to the intended treatment site.The delivery catheter kinked when extra force was used during device advancement, and the balloon may have been damaged at this time.The vbx endoprosthesis also started to dislodge from the catheter as it reached the treatment area.The balloon did not inflate when deployment was initiated.The balloon catheter was removed through the sheath and a 4 mm abbott balloon was inserted.The vbx device was expanded to 14 mm using the abbott balloon.The procedure ended with good results.The patient did not experience any adverse consequences.

Manufacturer Narrative

H6 - code 213: review of device manufacturing record history confirmed device met pre-release specifications.The engineering evaluation state the stent was not returned.The balloon catheter lot number on the returned delivery system matches 11 x 59 x 1350 mm configuration.The cover material beyond where the stent would have been, is compliant on both ends and pleats were observed in the cover material.The device showed a kink at 86.5-87 cm and visible damage from 88.5-90.5 cm from the proximal end of the delivery system.The balloon did not successfully inflate when attempted, but the delivery system was confirmed to not leak as the endoflator was taken up to 24 atm (past the rated burst pressure).The observed pleats in the balloon cover demonstrate that the balloon was inflated during the manufacturing process and capable of inflating after it was released from gore.Based on the device examinations 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: 8759862
• MDR Text Key: 150143753
• Report Number: 2017233-2019-00497
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 00733132637744
• UDI-Public: 00733132637744
• 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
• Report Date: 07/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2021
• Device Catalogue Number: BXA115902A
• Device Lot Number: 17902228
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2019
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 66 YR