MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS

Model Number	BXAL085902A
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	01/14/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional manufacturer narrative: a review of the manufacturing records indicated the device met pre-release specifications.The device was not returned for an engineering evaluation.Consequently, a direct product analysis was not possible.Additional information about this event could not be obtained.As a result, no further investigation is possible.
Event or Problem Description
The following was reported to gore: on (b)(6) 2020 the patient presented with complete occlusion of the right common iliac.An 8lmm x 59mm gore® viabahn® vbx balloon expandable endoprosthesis was successfully deployed and blood flow was restored.Approximately 2 hours after the completion of the surgery, the patient complained of leg pain.The patient was brought into the or and an angiogram was performed.It was then noticed that the previously implanted device had occluded.The physician reopened the cut down and used a fogarty balloon to remove the clot and administered heparin and eliquis to reduce clotting.It was reported the patient tolerated the procedure and is doing well.
Additional Manufacturer Narrative
Additional information, patient identifier - updated with the event number (b)(6) since patient id was not provided.Corrected event describe event or problem - updated date of event to (b)(6) 2020 in the event description.Other relevant history, including preexisting medical conditions - updated information.Patient medications - aspirin and protamine (the patient was given 10ml of protamine at the end of the procedure).
Event or Problem Description
On (b)(6) 2020 the patient presented with complete occlusion of the right common iliac artery.

• Brand Name: GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9694896
• Report Number: 2017233-2020-00088
• Device Sequence Number: 16734802
• Product Code: PRL
• UDI-Device Identifier: 00733132637669
• UDI-Public: 00733132637669
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Report Date (Section B): 03/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/24/2022
• Device Model Number: BXAL085902A
• Device Catalogue Number: BXAL085902A
• Device Lot Number: 20503991
• 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
• Initial Report FDA Received Date: 02/11/2020
• Supplement Report FDA Received Date: 03/31/2020
• 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: Required Intervention
• Patient Age: 50 YR
• Patient Weight: 103