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

Catalog Number	VBC101002A
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	08/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the manufacturing records indicated the device met pre-release specifications.Examination of the returned device revealed the following: the deployment knob, deployment line, delivery catheter, and an introducer sheath were returned; the sheath was not evaluated as it is not a gore device; there was approximately 51 cm of deployment line connected to the deployment knob; there was 2 cm of columnar failure near the shrink sleeve; the remainder of the device appeared 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: the physician was performing an av access maintenance procedure.A 10x10 gore® viabahn® endoprosthesis was selected to be placed in the subclavian vein.The tech said the physician began pulling the deployment line to deploy the viabahn but it stopped before the stent was fully deployed.The physician described the deployment line as though it was hung up or caught on something.Somehow the physician was able to fully deploy the gore® viabahn® endoprosthesis but was unable to remove all the deployment line.Once the catheter was removed, the deployment line was cut at the skin level and the rest of the deployment line was left in the patient.
Additional Manufacturer Narrative
Corrected data: results code 1.Conclusion code 1.
Additional Manufacturer Narrative
Additional manufacturer narrative: evaluation of the returned images revealed the following: images provided do not allow for evaluation in relationship to this event.

• Brand Name: GORE VIABAHN® ENDOPROSTHESIS - 3
• Common Device Name: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 7842939
• Report Number: 2017233-2018-00536
• Device Sequence Number: 11154358
• Product Code: PFV
• UDI-Device Identifier: 00733132623617
• UDI-Public: 00733132623617
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P040037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/02/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/06/2021
• Device Catalogue Number: VBC101002A
• Device Lot Number: 17945429
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2018
• 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: 09/04/2018
• Supplement Report FDA Received Date: 09/13/2018; 10/02/2018
• 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: Other
• Patient Age: 60 YR
• Patient Weight: 61