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

Catalog Number PAJR050202E

Device Problems Break (1069); Difficult or Delayed Activation (2577)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/01/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation involved the analysis of relevant production records in view of supporting the identification of possible causes for the adverse event.A review of the manufacturing records indicated the device met pre-release specifications.The device was returned for investigation.Results pending completion of investigation.

Event Description

It was planned to implant a gore® viabahn® endoprosthesis with propaten bioactive surface using a 6fr super arrow-flex® sheath introducer (teleflex).Reportedly the viabahn® endoprosthesis was deployed at the intended location and the device expanded partially.Then the deployment line snapped.They managed to retract the viabahn® endoprosthesis partially back into the introducer sheath and removed it from the patient in a tandem with the introducer sheath.Another viabahn® endoprosthesis was used to complete the procedure.Reportedly the patient is doing well.

Manufacturer Narrative

Problem/evaluation code 213: the device was returned to w.L.Gore & associates for investigation.The following observations were made: the endoprosthesis, delivery catheter, part of the deployment line, and an introducer sheath were returned.The introducer sheath was not evaluated as it is not a gore product.The deployment line appeared to be broken.There was approximately 1.7cm still attached to the endoprosthesis with two single fibers coming from the end measuring approximately 0.5cm each.Approximately 0.7cm of the distal shaft, upon which the endoprosthesis is mounted, was exposed at the transition.Approximately 1.5cm of the endoprosthesis was partially expanded towards the tip end of the device.The remainder of the endoprosthesis was constrained by the inner braided constraining line.The endoprosthesis appeared to be damaged and contained outwardly flared struts and tape delamination throughout the expanded section.Deployment was able to be continued with traction on the deployment line at the endoprosthesis.The device history file was evaluated.No anomalies or non-routine maintenance were identified that could contribute to deployment line and constraint sleeve damage during assembly.Therefore, based on the evaluation performed, no manufacturing cause could be identified.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9252539
• MDR Text Key: 194021427
• Report Number: 2017233-2019-01095
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• PMA/PMN Number: P130006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 11/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/07/2022
• Device Catalogue Number: PAJR050202E
• Device Lot Number: 20510810
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2019
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1