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

Catalog Number PAH101002B

Device Problem Premature Activation (1484)

Patient Problem No Information (3190)

Event Date 07/17/2018

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing records indicated the device met pre-release specifications.

Event Description

The following information was reported to gore: on (b)(6) 2018 a patient was undergoing treatment of a complex aortic aneurysm involving the thoracic, abdominal and common iliac arteries.T-branch and zbis devices were utilized.An advanta v12 stent was implanted in the right internal iliac branch, with the intent that a gore® viabahn® endoprosthesis with heparin bioactive surface would also be implanted to maintain patency of the right internal iliac artery and to exclude the common iliac arty aneurysm.The gore® viabahn® endoprosthesis with heparin bioactive surface device could not be positioned within the advanta v12, so an attempt was made to withdraw the device, which was unsuccessful.It could not be pulled back into the sheath.After modifying the imaging angles, it was noted the proximal end of the device had expanded, which prevented positioning it through the advanta stent.From right femoral access, the tip of the amplatz guidewire, on which the device was loaded, was captured and positioned into the right external iliac, to release it into the external iliac artery.However when deployment was attempted the gore® viabahn® endoprosthesis with heparin bioactive surface would not release from the delivery system.A gibson incision was made and an external iliac arteriotomy was performed with removal of the device.

Manufacturer Narrative

Results code 2: 213: the engineering evaluation stated the following: the endoprosthesis, deployment line, delivery catheter and guidewire were returned.The guidewire was not evaluated as it is not a gore device.The endoprosthesis was inverted and had nitinol wire unravelling from the device, see c18-587 (3).There was 62 cm of deployment line coming from inside of the endoprosthesis with a single fiber at the end of the deployment line that measured 12 cm.There was columnar failure in 3 areas on the dual lumen catheter shaft.The first measured 4.5 cm and was located on the hub end of the catheter, the second measured 4 cm and was 71 cm from the hub end of the catheter, the third measured 105 cm and was 72 cm from the hub end of the catheter with 24 cm of metal wire from a non-gore device coming out of this section of dual lumen catheter.The distal tip of the delivery catheter was deformed.The remainder of the delivery catheter appeared stretched.The remainder of the device appeared unremarkable.Based on the device examination performed, no manufacturing anomalies were identified.Method code 3: 3331 imaging evaluation.Results code 3: 213 see b.7.For imaging evaluation.

• Brand Name: GORE VIABAHN® ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 7758197
• MDR Text Key: 116358495
• Report Number: 2017233-2018-00491
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 09/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/21/2020
• Device Catalogue Number: PAH101002B
• Device Lot Number: 17420256
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/07/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ADVANTA V12, T-BRANCH
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 80 YR
• Patient Weight: 100