MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN; SYSTEM, ENDOVASCULAR GRAFT, ARTERIOVENOUS (AV) DIALYSIS ACCESS CIRCUIT STENOSIS

Model Number VBHR071002A

Device Problem Activation, Positioning or Separation Problem (2906)

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

Event Date 07/24/2017

Event Type  malfunction  

Event Description

During deployment of a gore viabahn endo-graft, the deployment did not proceed as expected.The graft was withdrawn from the sheath without incident for the patient.The string to deploy the endo-graft malfunctioned at the beginning of the deployment.The string was caught on a scallop.You can't see anything wrong now because when we lifted the string off the scallop it was caught on, then it was fine.But, there was no way to get it off that scallop except to lift it off when the device was removed.Manufacturer response for endo-graft, gore viabahn (per site reporter).Implant given to gore rep.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, ARTERIOVENOUS (AV) DIALYSIS ACCESS CIRCUIT STENOSIS
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 north fourth st.; flagstaff AZ 86004
• MDR Report Key: 6816389
• MDR Text Key: 83492292
• Report Number: 6816389
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 08/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: VBHR071002A
• Device Catalogue Number: VBHR071002A
• Device Lot Number: S15326314
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/18/2017
• Device Age: 8 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/18/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/24/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO OTHER THERAPIES
• Patient Outcome(s): Other
• Patient Age: 79 YR