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

Model Number	BXA085901A
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.
Event or Problem Description
The following was reported to gore: on an unknown date in (b)(6) 2020, the patient presented with an unknown etiology in the left iliac artery and underwent treatment using a gore® viabahn® vbx balloon expandable endoprosthesis (vbx).The physician advanced the vbx device to the treatment zone and deployed the endoprosthesis.Upon successful deployment, attempts were made to deflate the balloon but were unsuccessful and confirmed by observation of contrast.The physician then used a new indeflator and syringes to attempt deflation, but were also unsuccessful.The physician continued deflation attempts for an extended period of time until a secondary physician could assist.The physicians then used a wire to pop the vbx balloon and completed the procedure.Reportedly, there were no observable kinks in the balloon line.The patient tolerated the procedure.
Additional Manufacturer Narrative
The following information was added: a2: patient age: 67 years old.A3: patient gender: male.Additionally, the incoming original mdr report has been included as an attachment.
Additional Manufacturer Narrative
No device was returned for evaluation so the following evaluation is based on information obtained from the event description and communication summary.Each device 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 device evaluation 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: ILIAC COVERED STENT, ARTERIAL
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 10833069
• Report Number: 2017233-2020-01445
• Device Sequence Number: 4087312
• Product Code: PRL
• UDI-Device Identifier: 00733132637324
• UDI-Public: 00733132637324
• Combination Product (Y/N): Y
• 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: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/30/2021

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: 06/12/2022
• Device Model Number: BXA085901A
• Device Catalogue Number: BXA085901A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/13/2020
• Supplement Date Received by Manufacturer: 10/13/2020; 10/13/2020
• Initial Report FDA Received Date: 11/12/2020
• Supplement Report FDA Received Date: 09/30/2021; 09/30/2021
• 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: Hospitalization
• Patient Age: 67 YR