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

Catalog Number VBH131002A

Device Problems Failure to Deliver (2338); Device Handling Problem (3265)

Patient Problem Vascular Dissection (3160)

Event Date 10/26/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Review of device manufacturing record history confirmed device met pre-release specifications.The engineering evaluation state only a portion of the distal catheter and a deployed endoprosthesis were returned.The remainder of the dual lumen, hub, and deployment knob were not returned.The dual lumen catheter shaft appeared severed approximately 1.5 cm from the transition.The endoprosthesis was fully expanded, still surrounding the distal shaft, upon which the endoprosthesis was mounted.The endoprosthesis appeared slightly constrained at 3 and 4 cm from the transition-end.The two strut rows nearest to the transition-end were disconnected from the graft.The deployment line had fiber loops at the end that were looped around the transition-end struts.The deployment line measured approximately 77 cm, with a fiber continuing 10 cm on the opposite end.The ends of the deployment line appeared cut or broken.The distal shaft appears to be elongated, measuring 14.5 cm.Based on the device examination performed, no manufacturing anomalies were identified.Instructions for use warnings section state, do not withdraw the gore® viabahn® endoprosthesis back into the introducer sheath once the endoprosthesis is fully introduced.Withdrawing the gore® viabahn® endoprosthesis back into the sheath can cause damage to the endoprosthesis, premature deployment, deployment failure, and / or catheter separation.If removal prior to deployment is necessary, withdraw the gore® viabahn® endoprosthesis to a position close to but not into the introducer sheath.Both the gore® viabahn® endoprosthesis and introducer sheath can then be removed in tandem.After removal, do not reuse the gore® viabahn® endoprosthesis or introducer sheath.

Event Description

As reported to gore, a patient presented for treatment of an aneurysm in the internal iliac artery.Access was gained from contralateral side.A 12fr sheath was used to advance a gore® viabahn® endoprosthesis over the bifurcation to patient's left side.The first (10x10) viabahn device was deployed with no issues.The second viabahn device was advanced to extend the first device.Deployment was initiated; however, the deployment line became stuck and broke after a portion of the line unzipped.The physician elected to remove the viabahn device by pulling it back into the sheath.As the device was pulled back and forth to get it into the sheath, the device started expanded inside the sheath.The sheath and the proximal portion of catheter were able to be removed from the patient's artery.However, the viabahn endoprosthesis and the distal portion of the catheter remained in the patient's artery.A cut-down was performed in order to remove the rest of the device.The procedure continued with access from the right side.Another viabahn device was advanced and deployed with no issues.The patient tolerated the procedure and is reportedly doing well.It was reported the removed device was scrunched from distal and proximal ends, creating a bubble-like appearance in the middle of the viabahn endoprosthesis.As reported, this was likely from the pushing and pulling of the viabahn device during attempts to pull the device back into sheath.

• 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: genevieve begay ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 7039321
• MDR Text Key: 92295435
• Report Number: 2017233-2017-00606
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 10/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/21/2019
• Device Catalogue Number: VBH131002A
• Device Lot Number: 15913670
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2017
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2016
• 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): Required Intervention
• Patient Age: 84 YR
• Patient Weight: 91