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

Catalog Number	BXA051902A
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	08/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the manufacturing records verified that the lot met release requirements.The device was not returned.Consequently, a direct product analysis was not possible.All information has been placed on file for use in tracking and trending.
Event or Problem Description
The fsa reported the following: the patient presented for endovascular repair.According to the doctor, the target location for the gore® viabahn® vbx balloon expandable endoprosthesis (vbx device) was the left renal with a tight orifice.The doctor manually 'shaped' the vbx device before putting it onto the wire.The doctor proceeded to advance the vbx device through a short 7fr terumo sheath from the groin to the left renal.The doctor was unable to cannulated the renal so attempted to withdraw the vbx device back into the sheath.During the attempted withdrawal, the device dislodged from the balloon but was still on the wire.The doctor successfully used the dislodged vbx device to treat a different lesion in the external iliac.The patient is fine.
Additional Manufacturer Narrative
Corrected data: h6.Method code 2.Additional manufacturer narrative: g5.- pre-1938.G5.- otc product.The complaint was for a stent dislodging from the delivery system balloon while attempting to advance the vbx to the left renal artery with a tight orifice.After being unable to access the renal, it was reported that the device was attempted to be pulled back into the introducer sheath when the dislodgement occurred.The ifu warns, ¿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¿¿ based on the engineer evaluation of the information obtained during the investigation, no product design or manufacturing anomalies were detected.

• 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: 9073696
• Report Number: 2017233-2019-00865
• Device Sequence Number: 1749271
• Product Code: NIO
• UDI-Device Identifier: 00733132637096
• UDI-Public: 00733132637096
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P160021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2019

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: 07/31/2021
• Device Catalogue Number: BXA051902A
• Device Lot Number: 18756561
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/16/2019
• Supplement Report FDA Received Date: 10/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR