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

Catalog Number	BXAL085902A
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	04/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional manufacturer narrative: review of the manufacturing records could not be completed as no lot number information was provided.The investigation is ongoing.
Event or Problem Description
The following was reported to gore: the patient presented for common iliac artery aneurysm repair.The gore® viabahn® vbx balloon expandable endoprosthesis (vbx) was being advanced up and over through a aaa device (previously implanted in 2014) with the help of a dfs 12x45 sheath.The device was advanced to the 180° point and the doctor felt resistance.The doctor reported the vbx catheter shaft appeared to accordion.The doctor elected to remove the device at that point.During removal the stent separated from the balloon and delivery catheter, remaining in the sheath.The sheath was removed with the stent inside.Another vbx was successfully advanced and implanted.
Additional Manufacturer Narrative
Additional information: examination of the returned device revealed the following: the received device had dislodged from the delivery system inside the gore dry seal sheath; the device displayed catheter damage directly after the catheter strain relief, and from 89.5 to 90.5 cm from the catheter hub assembly; an attempt was made to pass a 12 french dilator down the introducer sheath; the dilator became stuck soon after entering the device and could not be advanced any further.The root cause for the dilator kinks, damage, and the inability to pass a dilator down the sheath could not be determined.
Additional Manufacturer Narrative
Additional manufacturer narrative: review of the manufacturing records verified that the lot met release requirements.Based on the device examination performed, no manufacturing anomalies were identified to which the event could be definitively attributed.

• Brand Name: GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8593494
• Report Number: 2017233-2019-00327
• Device Sequence Number: 11307811
• Product Code: NIO
• UDI-Device Identifier: 00733132637669
• UDI-Public: 00733132637669
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P160021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/14/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/11/2022
• Device Catalogue Number: BXAL085902A
• Device Lot Number: 20282948
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 05/08/2019
• Supplement Report FDA Received Date: 05/15/2019; 06/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EVAR, (B)(6) 2014
• Outcome Attributed to Adverse Event: Other
• Patient Age: 82 YR