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

Catalog Number PAJR072502E

Device Problems Separation Failure (2547); Difficult or Delayed Activation (2577)

Patient Problems Thrombus (2101); No Consequences Or Impact To Patient (2199); Device Embedded In Tissue or Plaque (3165)

Event Date 07/16/2019

Event Type  malfunction  

Event Description

The patient presented with a distal edge stenosis of a gore® viabahn® endoprosthesis which was previously implanted in the right superficial femoral artery.The stenosis was treated with a bare metal stent (innova).It was planned to additionally implant a gore® viabahn® endoprosthesis with propaten bioactive surface within the previously implanted viabahn® endoprosthesis.It was reported that when the viabahn® endoprosthesis was deployed, it moved slightly forward in distal direction and it only expanded halfway, then the deployment line has broken.Then the physician opened the catheter proximally to reach the remaining deployment line.When pulling the remaining deployment line it broke again.It was stated that it was not necessary to use excessive force when pulling the deployment line to deploy the device.The deployment line ruptured pretty easily.The physician decided to make a distal approach via a pedal access.He advanced a balloon from distal direction to the halfway expanded viabahn® endoprosthesis and dilated the constrained part step by step.Eventually the viabahn® endoprosthesis was fully expanded and the delivery catheter could be removed from the patient.Reportedly the physician couldn't say for sure or rule it out whether a part of the deployment line remained in the patient.During the procedure a thrombus has come loose proximal which would require a reintervention.Due to lack of resources the reintervention was postponed.Reportedly the patient is doing well.

Manufacturer Narrative

D10: the endoprosthesis remains in the patient.Delivery catheter, deployment knob and deployment line were returned for investigation.H6: code-213: the following observations were made: the delivery catheter, deployment knob, and deployment line were returned.There was approximately 207 cm of deployment line with two single fibers at the end measuring 15 cm and 13 cm.The delivery catheter was returned in two pieces.The first piece measured approximately 5.5 cm from the hub and the second piece measured approximately 120 cm and included the distal tip.The second piece was cut in half for approximately 57 cm and a fiber was protruding from the cut delivery catheter.The distal shaft, upon which the endoprosthesis was mounted, was kinked at the transition.The remainder of the device was unremarkable.Based on the device examination performed, no manufacturing anomalies were identified to which the event could be definitively attributed.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8887029
• MDR Text Key: 154305287
• Report Number: 2017233-2019-00623
• 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: 09/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/25/2021
• Device Catalogue Number: PAJR072502E
• Device Lot Number: 20262569
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2019
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 61 YR