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

Catalog Number JHJR062502J

Device Problems Occlusion Within Device (1423); Difficult to Advance (2920)

Patient Problems Vascular System (Circulation), Impaired (2572); Vascular Dissection (3160)

Event Date 03/16/2017

Event Type  Injury  

Manufacturer Narrative

The review of the manufacturing paperwork verified that the lot met all pre-release specifications.According to the gore® viabahn® endoprosthesis instructions for use, complications associated with the use of the gore® viabahn® endoprosthesis may include but are not limited to trauma to the vessel wall.Jhjr062502j/14857935 = udi:(b)(4).

Event Description

On (b)(6) 2017, the patient presented with occlusion of the right superficial femoral artery (sfa) which was treated with two gore® viabahn® endoprostheses.As the patient also presented with chronic total occlusion of the left common iliac artery, femoro-femoral crossover bypass procedure was planned after the deployment of the gore® viabahn® endoprostheses.The access was obtained from the ipsilateral (right) side.It was reported that there was difficulty in inserting the guidewire into the occlusion of the right sfa, and therefore the physician pushed and pulled the wire multiple times to successfully advance over the occlusion.After the distal device was deployed at the intended position with no issues, the intraoperative imaging identified a dissection at the proximal end of the right sfa, possibly caused by manipulation of the guidewire; however the cause of the dissection remained unknown.The procedure continued as planned, and the proximal device was deployed distal to the ostium of the distal deep femoral artery, post-dilation performed, and then femoro-femoral crossover bypass made with no issues.As another intraoperative images showed that the dissection was not fully covered by the proximal device, it was determined to perform surgical thrombectomy to repair the dissection and close the site with a patch.After the thrombectomy the patient's activated clotting time decreased.An endovascular thrombectomy was performed in the bypass graft.As an angiography revealed no flow to the distal deep femoral artery, another thrombectomy was attempted to the artery; however no thrombosis was removed.It was reported that the no-flow to the artery might have caused by the dissection flap closing the ostium of the artery, but the cause remained unknown.Final angiography revealed flow to the artery, the physician elected to conclude the procedure.The patient tolerated the procedure.

• 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 86005
• Manufacturer Contact: miyuki kurihara ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 6488877
• MDR Text Key: 72657700
• Report Number: 2017233-2017-00201
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 03/16/2017

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: 09/29/2018
• Device Catalogue Number: JHJR062502J
• Device Lot Number: 14857935
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2015
• 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): Other
• Patient Age: 66 YR