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

Catalog Number PAC111002

Device Problems Entrapment of Device (1212); Failure to Advance (2524)

Patient Problem Perforation of Vessels (2135)

Event Date 01/21/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The review of the manufacturing records verified that the lot met all pre-release specifications.

Event Description

It was reported to gore that a gore® viabahn® endoprosthesis was to be implanted for treatment of large pseudoaneurysm with defect in the middle of left brachial artery.The left axillary and middle of brachial artery were tortuous.After dilation was performed in the left upper arm vessels, the viabahn® device was accessed from the right femoral artery through an 11fr sheath, however it was difficult to advance to the target lesion.The physician did not initiate deployment and decided to retract the viabahn® device out of the patient, however the device was stuck and not able to retract through the sheath.A cut-down was performed on the femoral artery to remove the viabahn® device out of the patient.After removal of viabahn® device, it was observed the rest of device was still constrained, except for the proximal of device was expanded like a small balloon due to the deployment line was unraveled in this portion.The endoprosthesis was compressed distally and displaced on the shaft.The deployment line was observed broken.Additional information was received on (b)(6) 2018 that the patient's outcome is fine.

Manufacturer Narrative

The device was returned for evaluation.The analysis of the returned device stated that the viabahn® device arrived with an introducer sheath, which was not evaluated as it is not a gore device.Approximately 3 cm of the distal shaft, upon which the endoprosthesis is mounted, was exposed at the transition.Approximately 1.4 cm of the endoprosthesis was expanded near the transition end.The inner braided constraining line appeared to have been partially separated, with deployment lines woven into the stent struts.The remainder of the endoprosthesis was constrained.The deployment line was broken/cut near the partially expanded area of the endoprosthesis.There was approximately 4 cm of deployment line connected to the outer braided constraining line and 6 cm of deployment line coming from the transition.The deployment line appeared taut within the hub.Based on the device examination performed, no manufacturing anomalies were identified.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 7262599
• MDR Text Key: 99767412
• Report Number: 2017233-2018-00089
• 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: distributor
• Type of Report: Initial,Followup,Followup
• Report Date: 04/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/17/2019
• Device Catalogue Number: PAC111002
• Device Lot Number: 14972192
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention