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

Model Number BXA095902A

Device Problem Inflation Problem (1310)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/20/2020

Event Type  malfunction  

Manufacturer Narrative

The engineering evaluation is currently in progress.

Event 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.

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 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.

Manufacturer Narrative

H.6.Conclusion code updated.

• Brand Name: GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS
• Type of Device: 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
• MDR Text Key: 225319376
• Report Number: 2017233-2020-01503
• Device Sequence Number: 1
• Product Code: PRL
• UDI-Device Identifier: 00733132637379
• UDI-Public: 00733132637379
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 11/05/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Sex: Male