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

Catalog Number JHJR061002J

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Thrombosis (2100)

Event Date 12/27/2017

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing records for the device could not be conducted as lot number of the device was not available.According to the gore® viabahn® endoprosthesis instructions for use (ifu), device-related complications and adverse events include, but are not limited to thrombosis or occlusion of device.(b)(4).

Event Description

On an unknown date, the patient underwent an arterio-venous shunt procedure whereby a non-gore manufactured vascular graft was implanted in the patient¿s upper arm.Later, the vascular graft stenosis had been revealed for multiple times.On (b)(6) 2017, the patient was implanted with a gore® viabahn® endoprosthesis (jhjr061002j with an unknown lot number) to repair the graft stenosis.The patient tolerated the procedure.On (b)(6) 2017, thrombosis of the existing endoprosthesis was revealed.On the same day, thrombectomy as well as percutaneous balloon angioplasty (pta) were performed.On (b)(6) 2018, recurrent thrombosis of the existing endoprosthesis was revealed.On the same day, thrombectomy as well as pta were performed.The patient tolerated the reintervention procedure.

Manufacturer Narrative

Device available for evaluation corrected this section to "yes" and put 2/15/2018 as the date of device return.Results of explant evaluation: device fragments involved in this reported event were received by gore from your institution and an explant evaluation was performed.Histopathological examination of the device fragments confirmed that luminal tissue typically consisted of acute thrombus.There were some regions in a couple of device fragments that represented blood stasis which is a non-physiologic response to the cessation of blood flow at the completion of device explantation.There was no evidence of infection in any submitted device fragments.The primary cause of endoprosthesis occlusion was not identified.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 7295443
• MDR Text Key: 100888250
• Report Number: 2017233-2018-00126
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• PMA/PMN Number: P130006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 09/07/2018

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 Catalogue Number: JHJR061002J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/25/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention