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

Catalog Number VBJR062502A

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Thrombosis (2100)

Event Date 02/12/2018

Event Type  Injury  

Manufacturer Narrative

Additional manufacturer narrative: a review of the manufacturing records indicated that the device met pre-release specifications.The device was not returned.Consequently, a direct product analysis was not possible.All information has been placed on file for use in tracking and trending.(b)(4).

Event Description

The following was reported to gore: the patient presented with a left sfa occlusion.A gore® viabahn® endoprosthesis was implanted with good results.According to the doctor, the patient, approximately 2 weeks post implant, tested positive for hit using elisa & sra tests.Additionally, the patient received a thrombectomy, thrombolysis, and additional stenting at that time (approx.2 weeks post implant).

Manufacturer Narrative

Udi: (b)(4).

Manufacturer Narrative

Corrected data: event description, implant date.

Event Description

The following was reported to gore by the doctor: the gore® viabahn® endoprosthesis with heparin was implanted on (b)(6) 2018.Stent occluded (b)(6) - tpa and penumbra catheter used to dissolve clot.(b)(6) patient presents in er with ischemic symptoms in right leg.Additional thrombectomy, thrombolysis, & stenting occur.The gore® viabahn® endoprosthesis with heparin is currently open and patent.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 7332483
• MDR Text Key: 102181773
• Report Number: 2017233-2018-00163
• 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: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 04/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/29/2020
• Device Catalogue Number: VBJR062502A
• Device Lot Number: 17635053
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR