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

Catalog Number	VBJR061502A
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Activation Failure (3270)
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the manufacturing records verified that the lot met release requirements.Examination of the returned device revealed the following: the delivery catheter was returned and appeared to be unremarkable.Based on the device examination performed, no manufacturing anomalies were identified.All information has been placed on file for use in tracking and trending.
Event or Problem Description
The following was reported to gore by the doctor: the patient presented for a thoracic duct case.The gore® viabahn® endoprosthesis was to be placed in the patient's lymphatic system.The gore® viabahn® endoprosthesis was placed in the trunk of the lymphatic system (in the abdomen) and advanced to the subclavian vein.A second wire was advanced from the arm to snare the gore® viabahn® endoprosthesis in the lymphatic system.The doctor reported that patient anatomy was very tortuous.When the device was positioned, the deployment line was pulled.The deployment halted at the distal end of the gore® viabahn® endoprosthesis.The doctor was unable to complete deployment of the gore® viabahn® endoprosthesis so proceeded with standard treatment of using glue and a coil to seal off the duct.The gore® viabahn® endoprosthesis remains in the patient.According to the doctor, the patient is fine.
Additional Manufacturer Narrative
Additional manufacturer narrative: a1: patient identifier.G5: pre-1938.G5: otc product.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• Common Device Name: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8952682
• Report Number: 2017233-2019-00782
• Device Sequence Number: 11380584
• Product Code: PFV
• UDI-Device Identifier: 00733132623747
• UDI-Public: 00733132623747
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: P040037
• 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,Followup
• Report Date (Section B): 10/02/2019

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: 03/15/2021
• Device Catalogue Number: VBJR061502A
• Device Lot Number: 18309766
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2019
• 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: 08/30/2019
• Supplement Report FDA Received Date: 10/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1