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

Catalog Number JHJR061502J

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Occlusion (1984)

Event Date 10/18/2019

Event Type  Injury  

Event Description

On (b)(6) 2019, the patient underwent an endovascular repair for an occlusion of the left superficial femoral artery using a gore viabahn endoprosthesis.The sheath was inserted from the right femoral artery (contralateral approach).The delivery catheter of the gore viabahn endoprosthesis (6 mm x 25 cm) was attempted to advance through the sheath.However, the delivery catheter was not able to be advanced into the sheath.The delivery catheter was removed and it was observed the delivery catheter was kinked near the transition.It was reported the delivery catheter was advanced using excessive force because the terminal aorta was severely curved.The physician made the decision to not use this device, as it was reported the guidewire was not able to be inserted into the delivery catheter, due to the catheter kink.It was reported two 6 mm x 15 cm gore viabahn endoprostheses were used as replacement.The endoprostheses were implanted in their intended location.Reportedly, intraopertive imaging identified the popliteal artery was occluded due to thrombus scatter.A bypass procedure was reportedly performed to secure blood flow to the lower limb.The patient tolerated the procedure.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9325115
• MDR Text Key: 166499937
• Report Number: 2017233-2019-01146
• 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: 12/16/2019

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: 07/07/2022
• Device Catalogue Number: JHJR061502J
• Device Lot Number: 20956911
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/14/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention