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

Catalog Number JHJR062502J

Device Problem Complete Blockage (1094)

Patient Problem Occlusion (1984)

Event Date 04/25/2019

Event Type  Injury  

Manufacturer Narrative

During same procedure, a second gore® viabahn® vbx balloon expandable endoprosthesis was implanted (lot number: 20344093, udi number: (b)(4)).Review of device manufacturing record history confirmed both devices met pre-release specifications.The devices remain implanted.Therefore, direct product analysis was not possible.

Event Description

The following was reported to gore: on (b)(6) 2019, patient with peripheral artery disease was treated in the left superficial femoral artery using gore® viabahn® endoprostheses with heparin bioactive surface.From contralateral access, the first endoprosthesis (6 mm x 25 cm) was deployed in the distal portion of the stenotic occlusion.The second endoprosthesis (6 mm x 10 cm) was deployed proximal to the first vbx device.Good blood flow was confirmed and the procedure concluded.After the puncture site compression ended on (b)(6) 2019, the patient complained of leg pain.Angiography showed that the vbx devices were occluded.Reportedly, the physician also suspected that thrombus scattered from the puncture site.On the same day, ipsilateral access was made and thrombus aspiration was performed.Since it was possible that thrombus scattered to the left anterior tibial artery, thrombus aspiration was also performed using a 5fr angiographic catheter.Final angiography confirmed blood flow to the ankle.The patient tolerated the procedure.

Manufacturer Narrative

Conclusion code was updated / corrected.

• Brand Name: GORE VIABAHN® ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8630058
• MDR Text Key: 145843474
• Report Number: 2017233-2019-00366
• 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
• Report Date: 06/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/09/2022
• Device Catalogue Number: JHJR062502J
• Device Lot Number: 20342015
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR