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

Catalog Number PAC060502

Device Problem Activation Failure (3270)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/08/2019

Event Type  Injury  

Manufacturer Narrative

The review of the manufacturing records verified that this lot met all pre-release specifications.Per the gore® viabahn® endoprosthesis instructions for use (ifu), w.L.Gore & associates acknowledges that although rare, complications and adverse events such as deployment failure may occur.We recommend that use of a stiff guide wire for best results when deploying the device.

Event Description

It was reported to gore that a 6mm x 5cm gore® viabahn® endoprosthesis was to be implanted for treatment of pseudoaneurysm caused by av fistula.When the device was advanced to the target lesion, after initiating the deployment line, the device could not deploy.Then the endoprosthesis was retracted out of the patient.

Event Description

It was reported to gore that a 6mm x 5cm gore® viabahn® endoprosthesis was to be implanted for treatment of pseudoaneurysm caused by av fistula.When the device was advanced to the target lesion, after initiating the deployment line, the device could not deploy.Then the endoprosthesis was retracted out of the patient.The physician did the bypass to complete the procedure.Confirmed with the fsa, the endoprosthesis partially expanded inside the patient's body.

Manufacturer Narrative

B5, the event description was updated.H6,conclusions code 1 was updated.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8580940
• MDR Text Key: 145168056
• Report Number: 2017233-2019-00317
• 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: 08/23/2019

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/10/2021
• Device Catalogue Number: PAC060502
• Device Lot Number: 20383941
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/05/2019
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 07/17/2019; 08/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention