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

Catalog Number	VBJR050502A
Medical Device Problem Code	Failure to Unfold or Unwrap (1669)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	07/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the manufacturing records for the device verified the lot met all pre-release specifications.
Event or Problem Description
The following information was reported to gore: on (b)(6) 2018 a patient was undergoing treatment of a splenic artery aneurysm with a gore® viabahn® endoprosthesis.The device was advanced over a.018" v18 wire through a 6fr terumo sheath, to the desired location.Deployment was initiated, however about halfway through deployment, the deployment line broke, leaving half of the device remaining constrained on the delivery catheter.The device was then pulled back through the brachial access.The case was finished by using coils to embolize the aneurysm.The case was completed with another device.The patient tolerated the procedure.
Additional Manufacturer Narrative
Should have been blank in the initial medwatch.Results code 2 updated: 213: the engineering evaluation stated the following: the following observations were made: the deployment knob, deployment line, endoprosthesis, and portion of the delivery catheter were not returned.The distal tip and distal shaft, upon which the endoprosthesis was mounted, were not returned.The dual lumen appeared to be cut at 115 cm past the hub (see c18-659 dual lumen cut 1.Jpg and c18-659 dual lumen cut 2.Jpg).The remainder of the dual lumen/transition were not returned.There were catheter kinks at 15, 31, 81, 87, and 96 cm from hub.Based on the device examination performed, no manufacturing anomalies were identified.

• Brand Name: GORE VIABAHN® ENDOPROSTHESIS - 3
• Common Device Name: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 7826895
• Report Number: 2017233-2018-00520
• Device Sequence Number: 13747095
• Product Code: PFV
• UDI-Device Identifier: 00733132623907
• UDI-Public: 00733132623907
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2018

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: 06/06/2020
• Device Catalogue Number: VBJR050502A
• Device Lot Number: 17230249
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2018
• 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: 08/29/2018
• Supplement Report FDA Received Date: 10/05/2018
• 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: Hospitalization; Other; Required Intervention
• Patient Age: 65 YR