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

Catalog Number PAH101002E

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

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

Event Date 05/27/2019

Event Type  malfunction  

Manufacturer Narrative

The device remains implanted in the patient.

Event Description

On unknown date an unknown lesion within the right external iliac artery was treated with an unknown bare metal stent.On (b)(6) 2019 the patient presented with external iliac artery bleeding in the region of the bare metal stent due to an iatrogenic defect.During an emergency procedure the bleeding was treated using a gore® viabahn® endoprosthesis with propaten bioactive surface.It was advanced to the lesion through an 11fr introducer sheath and positioned such that one-third of the previous bare metal stent was covered by the viabahn® endoprosthesis.When deployment was initiated the viabahn® endoprosthesis initially did not deploy.The deployment line was pulled until it could not be pulled further.Reportedly eventually the viabahn® endoprosthesis expanded about one-third of its length.Then the deployment line was again pulled as hard as possible.Eventually the viabahn® endoprosthesis expanded fully but the deployment line snapped.It was reported that the delivery system could be removed from the patient but not all the deployment line was retrieved from the patient.The removed part of the deployment line was inspected on the side table.Reportedly the deployment line showed severe mechanical abrasion damage.Reportedly it was suspected that the deployment line got stuck on the previous bare metal stent.It was stated that the patient is doing well.

Manufacturer Narrative

D10 and h3 and h6: code-4116: the endoprosthesis remains in the patient.Delivery catheter and deployment line were returned for investigation.H6: code-213: the review of the manufacturing paperwork verified that this lot met all pre-release specifications.During the investigation of the returned delivery catheter and deployment line the following observations were made: the deployment line was broken.The first piece measured approximately 72 cm.The second piece was coming out of the transition and measured approximately 37cm.The delivery catheter exhibited damage on the distal tip that appeared to be columnar failure.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: 8712158
• MDR Text Key: 148426991
• Report Number: 2017233-2019-00448
• 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: 06/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/18/2020
• Device Catalogue Number: PAH101002E
• Device Lot Number: 17206565
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2019
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1