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

Catalog Number PAHR070502E

Device Problem Patient-Device Incompatibility (2682)

Patient Problem No Code Available (3191)

Event Date 12/17/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The following was reported to gore.On (b)(6) 2017, a gore® viabahn® endoprosthesis was implanted in a ruptured popliteal artery.The device was implanted as intended with acceptable blood flow at the end of the procedure.It was reported that after one day reduced blood flow was noticed and it was necessary to explant the device.The physician stated that this was likely caused due to a malformation of the vessel at the location of the implant.The patient tolerated the procedure.

Manufacturer Narrative

The device was returned to w.L.Gore & associates for investigation.Submitted unfixed was one gore® viabahn® endoprosthesis.The lumen of the device was widely patent.The luminal and abluminal device surfaces were generally devoid of tissue except for scattered plaques of friable red brown material consistent with dried blood.A longitudinal transection made prior to arrival at w.L.Gore & associates is present, and the distal contour of the device is mildly uneven.Histopathological examination was not performed due to the paucity of adherent tissue.The device was subjected to an enzymatic digestion process to remove biologic debris.Following digestion the device was examined for material disruptions with the aid of a stereomicroscope.No wear related disruptions were identified.A longitudinal transection is present that is consistent with surgical explantation.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 7178016
• MDR Text Key: 96825839
• Report Number: 2017233-2018-00013
• 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: 03/28/2018

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 Expiration Date: 11/09/2019
• Device Catalogue Number: PAHR070502E
• Device Lot Number: 16130748
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/10/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 30 YR