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

Model Number	BXA095902A
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The engineering evaluation is currently in progress.
Event or Problem Description
The following was reported by the gore fsa: the patient presented for a snorkel case.The gore® viabahn® vbx balloon expandable endoprosthesis was advanced into the celiac artery.The physician was only able to obtain 4 atmospheres during the inflation of the device.The physician was able to remove the balloon and insert a different balloon, successfully deploying the gore® viabahn® vbx balloon expandable endoprosthesis.There was no harm to the patient.
Additional Manufacturer Narrative
H.6.Conclusion code updated.
Additional Manufacturer Narrative
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.H.6.Results code 1: 213: a review of the manufacturing records verified the lot met all pre-release specifications.H.6.Results code 2: 213 the engineering analysis stated the following: the as-reported complaint, partial deployment, cannot be directly confirmed because the endoprosthesis remains implanted.Balloon leakage is confirmed and is considered the cause of reported partial deployment.The cause of the damage to the balloon cannot be further identified.
Event or Problem Description
The following information was reported to gore: on (b)(6) 2020 a patient presented for a snorkel case.A gore® viabahn® vbx balloon expandable endoprosthesis was advanced into the celiac artery.During the inflation of the device, only 4 atmospheres could be obtained.The vbx balloon was removed and replaced with a different balloon, successfully deploying the gore® viabahn® vbx balloon expandable endoprosthesis.There was no harm to the patient.

• 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
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: heidi inskeep ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 10952766
• Report Number: 2017233-2020-01503
• Device Sequence Number: 11051322
• Product Code: PRL
• UDI-Device Identifier: 00733132637379
• UDI-Public: 00733132637379
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• 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): 11/05/2021

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: 11/17/2022
• Device Model Number: BXA095902A
• Device Catalogue Number: BXA095902A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 11/23/2020
• Supplement Date Received by Manufacturer: 01/13/2021; 11/05/2021
• Initial Report FDA Received Date: 12/05/2020
• Supplement Report FDA Received Date: 03/11/2021; 11/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Sex: Male