MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE VIABAHN® ENDOPROSTHESIS; STENT, SUPERFICIAL FEMORAL ARTERY

Catalog Number VBJR061502A

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Vascular System (Circulation), Impaired (2572)

Event Date 06/20/2015

Event Type  Injury  

Event Description

As reported, on (b)(6) 2015, a gore® viabahn® endoprosthesis was used for the treatment of a superficial femoral artery (sfa) thrombosis.The 6mm x 15cm gore® viabahn® endoprosthesis was placed from the sfa origin to the proximal popliteal artery.On (b)(6) 2015, follow-up imaging revealed the 6mm x 15cm gore® viabahn® endoprosthesis migrated 2cm distally from the original placement.An embolectomy was performed at that time.On (b)(6) 2015, a 6mm x 25cm gore® viabahn® endoprosthesis was placed to reline the entire vessel segment.Post procedure, the blood flow looked good; however, a couple hours later, the patient developed symptoms and imaging revealed the 6mm x 25cm device had also migrated 2cm distally.Reportedly, the physician felt an anomaly may have been present which may have contributed to the two devices migrating distally.A common femoral to popliteal artery bypass procedure was performed.On (b)(6) 2015, the patient received an amputation.

Manufacturer Narrative

Review of the manufacturing paperwork has been conducted.The review of the manufacturing paperwork verified that this lot met all pre-release specifications.Image analysis summary (b)(6) 2015 - the sfa appears to have minimal flow.There appears to be a catheter in the proximal sfa.Contrast injection into the sfa directly appears to show contrast in the sfa.There appears to be the proximal end of a device deployed in the distal end of the sfa.There appears to be a second device deployed in the proximal sfa with the radiopaque markers at the level of the common femoral bifurcation.(b)(6) 2015 - comparing the (b)(6) to the (b)(6) the proximal end that did appear at the level of the common femoral bifurcation appears to have moved distally approx.2-3cm.There does not appear to be contrast/flow in the devices implanted in the sfa.(b)(6) 2015 am - comparing the (b)(6) to the (b)(6) the distal end of the original devices appears to have moved distally approx.2-3cm.There appears to be minimal flow through the devices.There appears to be a catheter injection within the devices which demonstrates flow lumen abnormalities within the vessel distal to the devices.There does not appear to be contrast in the tibioperoneal trunk.There appears to be a new device deployed within the proximal end of the current devices extending to the common femoral bifurcation.(b)(6) 2015 pm -there does not appears to be contrast in the devices.The proximal end of the devices appears to have moved distal from the deployed location which was at the level of the common femoral bifurcation.There appears to have been a surgical bypass graft implanted with the distal anastomosis at the level of the popliteal artery.

• Brand Name: GORE VIABAHN® ENDOPROSTHESIS
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86001
• Manufacturer Contact: roger smith ; 1500 n. 4th street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 4930568
• MDR Text Key: 6049807
• Report Number: 2017233-2015-00436
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2017
• Device Catalogue Number: VBJR061502A
• Device Lot Number: 13189447
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR