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

Catalog Number JHJR062502J

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Occlusion (1984); Claudication (2550)

Event Date 12/01/2018

Event Type  Injury  

Manufacturer Narrative

Literature citation: a case of acute occlusion of viabahn, okinawa medical journal, volume 57, number 3, page 83 (published in december 2018).Additional devices involved in event: jhr060502j no lot number or udi available and jhjr060202j no lot number or udi available.A review of the manufacturing records could not be conducted since the requested lot numbers remain unknown.

Event Description

The following publication was reviewed: a case of acute occlusion of viabahn on an unknown date, a (b)(6) year old female underwent endovascular repair for chronic total occlusion (cto) of the left superficial femoral artery using gore® viabahn® endoprosthesis with heparin bioactive surface.A 6.0 mm x 2.5 cm viabahn was implanted distally, and 6.0 mm x 5 cm viabahn was implanted proximally.During post ballooning, a dissection was noted at the distal portion of the endoprosthesis, so an additional 6.0 mm x 2.5 cm viabahn was implanted to repair the dissection.Good blood flow was observed, and the patient tolerated the procedure.Nine days after the initial procedure was performed, the patient exhibited numbness of the left leg.Ten days after the initial procedure the patient experienced pain in the left leg when walking only two or three meters.The patient presented to the hospital, and it was confirmed that the left leg was cold and the left popliteal and dorsal arteries were impalpable.Therefore, an emergent thrombectomy with a fogarty catheter was performed for acute occlusion of the endoprostheses.Blood flow was restored, and occlusion was no longer observed.

Manufacturer Narrative

Patient identifier updated.

Manufacturer Narrative

Literature article attached.- attachment: [literature article event # 40141.Pdf].

• Brand Name: GORE VIABAHN® ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8512505
• MDR Text Key: 141910414
• Report Number: 2017233-2019-00247
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 07/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: JHJR062502J
• 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): Hospitalization; Other; Required Intervention
• Patient Age: 66 YR