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

Catalog Number	BXA112902A
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Material Split, Cut or Torn (4008); Difficult or Delayed Separation (4044)
Health Effect - Clinical Codes	Calcium Deposits/Calcification (1758); Occlusion (1984)
Date of Event	05/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional manufacturer narrative: review of the manufacturing records verified that the lot met release requirements.The device was not returned.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.All information has been placed on file for use in tracking and trending.
Event or Problem Description
The following was reported to the gore fsa by the doctor: the patient presented for a flow reversal case.The gore® viabahn® vbx balloon expandable endoprosthesis was advanced through the 8fr silk road medical sheath and deployed as expected.As the balloon was being withdrawn, it got stuck in the introducer sheath and came off the catheter when the doctor pulled back (after it was stuck in the sheath).The introducer and catheter were removed together with no further incident.The patient was reported to be fine.The catheter was discarded at the hospital.

• Brand Name: GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8640991
• Report Number: 2017233-2019-00352
• Device Sequence Number: 2446171
• Product Code: NIO
• UDI-Device Identifier: 00733132637706
• UDI-Public: 00733132637706
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/10/2019

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: 07/03/2021
• Device Catalogue Number: BXA112902A
• Device Lot Number: 18455694
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SILK ROAD DEVICE
• Outcome Attributed to Adverse Event: Other
• Patient Age: 74 YR