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

Catalog Number PAC101002E

Device Problem Difficult or Delayed Activation (2577)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/29/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2019, the patient underwent endovascular treatment of a femoral-popliteal aneurysm using two gore viabahn® endoprostheses.The first viabahn® device (5mm x 15cm, lot number unknown) was implanted distally with no issues.It was intended to implant a second viabahn® device (10mm x 10cm, lot number 19946750) proximally with some overlap.After initiating the deployment of the second viabahn® device it deployed approximately 3cm when big resistance was experienced while pulling the deployment knob.The deployment line got stock temporarily, and by the second harder pull the viabahn® device fully deployed but it was shortened by 2-3cm.It was suspected that the deployment line might got stuck between the viabahn® devices.It was reported that when removing the delivery system from the patient a short piece of red colored line was protruding from the access site.The physician manually pulled the line and removed it from the patient.It extended to approximately 30cm.The patient is doing well.It was reported that the treatment planning included a long sealing zone.Therefore no endoleak was seen despite the second viabahn® device was shortened.The result was described to be perfect.

Event Description

On (b)(6) 2019 the patient underwent endovascular treatment of a femoral-popliteal aneurysm using two gore viabahn® endoprostheses.The first viabahn® device (9 mm x 15 cm, lot number 20317150) was implanted distally with no issues.It was intended to implant a second viabahn® device (10 mm x 10 cm, lot number 19946750) proximally with some overlap.After initiating the deployment of the second viabahn® device it deployed approximately 3 cm when big resistance was experienced while pulling the deployment knob.The deployment line got stock temporarily, and by the second harder pull the viabahn® device fully deployed but it was shortened by 2-3cm.It was suspected that the deployment line might got stuck between the viabahn® devices.It was reported that when removing the delivery system from the patient a short piece of red colored line was protruding from the access site.The physician manually pulled the line and removed it from the patient.It extended to approximately 30 cm.The patient is doing well.It was reported that the treatment planning included a long sealing zone.Therefore no endoleak was seen despite the second viabahn® device was shortened.The result was described to be perfect.

Manufacturer Narrative

Added patient identifier; updated event description.Code-4116: the device remains implanted in the patient.The delivery catheter was returned for investigation.During investigation of the delivery catheter the following observations were made: the dual lumen was kinked 8 cm, 45 cm, 76 cm, and 111 cm from the hub.The remainder of the device was unremarkable.Engineering evaluation conclusion is inconclusive as it relates to the event description.Based on the device examination performed, no manufacturing anomalies were identified.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: 8527440
• MDR Text Key: 142491143
• Report Number: 2017233-2019-00259
• 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: 04/29/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 07/15/2021
• Device Catalogue Number: PAC101002E
• Device Lot Number: 19946750
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/18/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization