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

Catalog Number PAJ062502

Device Problem Failure to Unfold or Unwrap (1669)

Patient Problem Perforation of Vessels (2135)

Event Date 02/27/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The following information was reported to gore: on (b)(6) 2018 a patient was undergoing treatment of a superficial femoral artery occlusion with a gore® viabahn® endoprosthesis with propaten bioactive surface.The lesion was pre-dilated with a pta balloon.The gore® viabahn® endoprosthesis with propaten bioactive surface was advanced over a wire through a short 6fr sheath and positioned for deployment.Device deployment was initiated.Approximately one third of the deployment line was pulled when the deployment line became stuck, and deployment would not continue.The endoprosthesis was expanded halfway at this point.Deployment was attempted again, but was not successful.The procedure was converted to cut down with open repair under general anesthesia to remove the partially expanded endoprosthesis from the vessel.The patient did well following the open repair.

Manufacturer Narrative

The engineering evaluation stated the following: an introducer sheath was returned but was not evaluated as it is not a gore product.Approximately 56 cm of deployment line connected the hub to the deployment knob.The endoprosthesis appeared compressed towards the tip end of the device.There was 7 cm of exposed distal shaft, upon which the endoprosthesis is mounted, at the transition.The endoprosthesis was partially expanded a total of 4 cm at the tip end.There was also partial expansion at 5.5, 6, and 19 cm from the tip end of the endoprosthesis.The deployment line nearest to the 4 cm of partial expansion appeared normal at 9 cm from the tip end of the device there is a single fiber from the deployment line that was looped around the constrained endoprosthesis.At 11 cm from the transition end, there were broken fibers.Based on the device examination performed, no manufacturing anomalies were identified.

Event Description

On (b)(6) 2018 a patient was undergoing treatment of a superficial femoral artery occlusion with a gore® viabahn® endoprosthesis with propaten bioactive surface.The lesion was pre-dilated with a pta balloon.The gore® viabahn® endoprosthesis with propaten bioactive surface was advanced over a wire through a short 6fr sheath and positioned for deployment.Device deployment was initiated.Approximately one third of the deployment line was pulled when the deployment line became stuck, and deployment would not continue.The endoprosthesis was expanded halfway at this point.Deployment was attempted again, but was not successful.The procedure was converted to cut down with open repair under general anesthesia to remove the partially expanded endoprosthesis from the vessel.Three abbott eluvia stents were implanted and post-ballooned to complete the procedure.The patient did well following the open repair.Three weeks postoperatively the patient was doing very well with no further issues or complications.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: heidi inskeep ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 7366391
• MDR Text Key: 103332948
• Report Number: 2017233-2018-00184
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/27/2018

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: 05/08/2020
• Device Catalogue Number: PAJ062502
• Device Lot Number: 17220345
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/23/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 65 YR