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	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Information regarding the second vbx device utilized in the procedure: lot/ serial number: (b)(4).Catalog number: bxa085901a.Udi: (b)(4).Product history review: a review of the manufacturing records indicated the lot met pre-release manufacturing specifications.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 (b)(6) 2020, the patient with bilateral iliac occlusions and underwent treatment utilizing two gore® viabahn® vbx balloon expandable endoprostheses.The physician advanced both vbx devices to the treatment zone and initiated deployment.One vbx device ((b)(4)) was deployed without issue.The second endoprosthesis' ((b)(4)) balloon ruptured at nominal pressure but complete deployment was successful.The ruptured balloon was withdrawn without issue and another balloon was used for post dilation.Since both vbx devices were deployed at the same time and are identical in size, it is unknown which vbx device is associated with the balloon rupture.The patient tolerated the procedure.

• 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: 11381977
• Report Number: 2017233-2021-01711
• Device Sequence Number: 3781534
• Product Code: PRL
• UDI-Device Identifier: 00733132637324
• UDI-Public: 00733132637324
• Combination Product (Y/N): Y
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: P160021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/25/2021

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: 08/11/2023
• Device Model Number: BXA085901A
• Device Catalogue Number: BXA085901A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/28/2021
• Initial Report FDA Received Date: 02/25/2021
• 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: 61 YR