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

Catalog Number PAH111002E

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/13/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The patient presented to be treated for a branched endovascular repair of the aortic arch where it was intended to have a gore® viabahn® endoprosthesis implanted from the first branch to the right common carotid artery.It was reported to gore that when viabahn® device deployment was initiated, the endoprosthesis deployed for approximately 5cm until resistance was recognized which did not allow to further deploy the viabahn® device.Further deployment couldn't be continued at first.Significant manipulation was necessary to continue opening of the viabahn® device by moving the delivery catheter up and down.The deployment line could not be withdrawn and stayed fixated to the graft.Therefore the delivery catheter could only be removed by cutting the plastic hub at the end of the deployment line off.The access sheath (12f flexor ansel 45cm) could then be advanced until contacting the graft and with significant force the pulling line was then withdrawn.Where it ruptured was unknown.The impression was that it ruptured at the fixation on the graft.During device removal it was noticed that the endoprosthesis was shortened.The repair was extended with 2 fluency® plus endovascular stent grafts.The physician stated in written that meanwhile the patient passed away due to another cause.

Manufacturer Narrative

Pma/510k: combination product was changed to "yes.".

Manufacturer Narrative

Code-4116: the endoprosthesis remained in the patient.Delivery catheter and deployment line were returned for investigation.The following observations were made: the deployment line measured approximately 196 cm.There was a single loop of fiber coming off of the deployment line.The deployment line was fully intact.The dual lumen was kinked 8 and 61 cm from the hub.The remainder of the device was unremarkable.Code-213: based on the device examination performed, no manufacturing anomalies were identified.

Manufacturer Narrative

A1-a3 updated: patient identifier, date of birth, gender.D10 updated: device available for investigation: yes.

• Brand Name: GORE VIABAHN® ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8490964
• MDR Text Key: 142376390
• Report Number: 2017233-2019-00224
• 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,Followup,Followup
• Report Date: 05/31/2019

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: 09/17/2021
• Device Catalogue Number: PAH111002E
• Device Lot Number: 18788744
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/08/2019
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 05/06/2019; 05/15/2019; 06/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 72 YR