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

Catalog Number JHH111002J

Device Problems Break (1069); Physical Resistance (2578)

Patient Problems Rupture (2208); Foreign Body In Patient (2687)

Event Date 02/26/2017

Event Type  malfunction  

Manufacturer Narrative

The review of the manufacturing paperwork verified that the lot met all pre-release specifications.The observations obtained from the engineering evaluation are as follows; a single 185 cm long deployment line was returned with no knob attached.There is no specification on the length of this deployment line.One end of the deployment line has a bunched section of approximately 1.2 cm with a single fiber extending 16.5 cm beyond the bunched section.It is unknown if this end of the deployment line was broken but it does appear to have a broken fiber.The opposite end of the deployment line appears to be unremarkable.Based on the device examination performed, no manufacturing anomalies were identified.The cause of the event could not be determined with the information available.(b)(4).

Event Description

On (b)(6) 2017, the patient underwent an endovascular procedure using gore® viabahn® endoprosthesis to repair rupture of the right iliac artery caused by endovascular procedure of non-gore device.Bare metal stents were previously (date unknown) implanted in the right common iliac and external iliac artery with no overlap, and the bleeding was identified on the distal edge of the stent in the right common iliac artery.The delivery catheter was advanced with no issues to the intended position in the native vessel between the stents, overlapping the two stents.After initiating the deployment of the endoprosthesis, the endoprosthesis opened as intended; however the opening stopped due to resistance at the level of the proximal edge of the stent of the external iliac artery.It was reported that the resistance would have been caused by the deployment line being stuck.As the delivery catheter could be moved, it was decided to cut the deployment line at the hub, and then remove the catheter.As the catheter was forcibly removed, the undeployed portion of the endoprosthesis finally opened with the distal olive.The deployment line was then removed with no issues, and therefore the procedure continued.No other issues were identified, and the patient tolerated the procedure.It was indicated that there is a possibility of the deployment line breakage, and the fragment of the line would remain in the patient.

• 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: 6427064
• MDR Text Key: 71043493
• Report Number: 2017233-2017-00141
• 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,Followup
• Report Date: 03/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/22/2018
• Device Catalogue Number: JHH111002J
• Device Lot Number: 14852589
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2017
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/23/2015
• 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 Age: 76 YR