MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE VIABAHN® ENDOPROSTHESIS - 3; NIP

Catalog Number	VBH101002A
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	01/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional manufacturer narrative: review of the manufacturing records verified that the lot met release requirements.The investigation is ongoing.
Event or Problem Description
Medwatch #(b)(4) was received.The description of event reported to gore is as follows: gore® viabahn® endoprosthesis tracked to the left internal iliac artery aneurysm but would not track to the distal internal iliac artery.The doctor then performed balloon angioplasty of the distal orifice of the internal iliac artery using a 7mm x 4cm balloon.The doctor then tracked the gore® viabahn® endoprosthesis to the left internal iliac artery aneurysm but again it would not track to the distal internal iliac artery.At this point the gore® viabahn® endoprosthesis partially deployed 2 rings of the stent without pulling the trigger to deploy.This could not be re-captured within the sheath.The doctor then removed the gore® viabahn® endoprosthesis while partially deployed.According to the medwatch received, this caused trauma to the left iliac artery and left cfa.
Additional Manufacturer Narrative
Additional manufacturer narrative: event is reclassified as reportable malfunction.
Additional Manufacturer Narrative
Additional manufacturer narrative: a1 - patient identifier.B3 - date of event.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.Note: no exact date of event was provided.Therefore the event date, (b)(6) 2019 is an estimate based on information found in medwatch # (b)(4).Corrected data: h6: method code #2.H6: results code #2.H6: conclusion code #1.

• Brand Name: GORE VIABAHN® ENDOPROSTHESIS - 3
• Common Device Name: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8417431
• Report Number: 2017233-2019-00140
• Device Sequence Number: 16522805
• Product Code: PFV
• UDI-Device Identifier: 00733132623228
• UDI-Public: 00733132623228
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P040037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/24/2019

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: 10/04/2020
• Device Catalogue Number: VBH101002A
• Device Lot Number: 17522947
• 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; Not provided
• Initial Report FDA Received Date: 03/13/2019
• Supplement Report FDA Received Date: 05/15/2019; 05/24/2019
• 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: Other
• Patient Age: 84 YR