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

Model Number	BXA085901A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Occlusion (1984)
Date of Event	05/07/2020
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.
Event or Problem Description
The following was reported to gore: the patient presented for aortic bifurcation treatment.The gore® viabahn® vbx balloon expandable endoprosthesis (vbx) was advanced into the left common iliac for bilateral kissing treatment.The balloon was inflated and the vbx successfully expanded in the correct position.However, the doctor was unable to deflate the balloon.The doctor tried pulling negative pressure with a large syringe and then tried to pop the balloon with excessive pressure.Both attempts were unsuccessful.The doctor eventually used a transjugular intrahepatic portosystemic (tips) lancet needle to get the catheter/balloon out.There was no harm done to the patient.
Additional Manufacturer Narrative
Corrected data: d2.Common device name.Additional manufacturer narrative: the referenced complaint did not have a returned device.The following evaluation is based on information obtained from the event description and communication summary.Each balloon is 100% verified in process to inflate and deflate.The device history file was reviewed and no anomalies were identified.Machine history files were reviewed and no non-routine maintenance was identified.Based on the evaluation performed, no manufacturing anomalies were identified to which the event could be definitively attributed.
Additional Manufacturer Narrative
Additional manufacturing narrative: c1.Name (#1) - cbas® heparin surface; manufacturer/compounder: w.L.Gore & associates, inc.Lot #21490228.Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.

• Brand Name: GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS
• Common Device Name: ILIAC COVERED STENT, ARTERIAL
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 10081141
• Report Number: 2017233-2020-00379
• Device Sequence Number: 1073587
• Product Code: PRL
• UDI-Device Identifier: 00733132637324
• UDI-Public: 00733132637324
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P160021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/29/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/01/2022
• Device Model Number: BXA085901A
• Device Catalogue Number: BXA085901A
• Device Lot Number: 21490228
• 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; Not provided
• Initial Report FDA Received Date: 05/21/2020
• Supplement Report FDA Received Date: 07/23/2020; 07/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other