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

Catalog Number PAC111002

Device Problem Insufficient Information (3190)

Patient Problem Pseudoaneurysm (2605)

Event Date 03/22/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).The review of the manufacturing paperwork verified that this lot met all pre-release specifications.

Event Description

The following was reported to gore: on (b)(6) 2014, the patient underwent treatment of an aneurysm within the popliteal artery with two gore® viabahn® endoprosthesis.Reportedly the aneurysm was successfully resolved.On (b)(6) 2016, a false aneurysm of the left scarpa was detected.On (b)(6) 2016, the false aneurysm was solved with the implantation of an additional covered stent in the superficial femoral artery.The patient tolerated the procedure.

Event Description

The following was reported to gore: on (b)(6) 2014, the patient underwent treatment of an aneurysm within the popliteal artery with two gore viabahn endoprosthesis.Reportedly the aneurysm was successfully resolved.On (b)(6) 2016, a false aneurysm of the left scarpa was detected.On (b)(6) 2016, the false aneurysm was solved with the implantation of an additional covered stent (advanta v12 maquet) in the superficial femoral artery.The patient tolerated the procedure.

Manufacturer Narrative

Updated with additional information.

Event Description

The following was reported to gore: on (b)(6) 2014, the patient underwent treatment of an aneurysm within the popliteal artery with two gore viabahn endoprosthesis.The procedure was finalized without issues and the aneurysm was successfully resolved.On (b)(6) 2014, ultrasound imaging showed a femoral iatrogenic false aneurysm of the left scarpa.According to the physician the false aneurysm was caused by the percutaneous procedure.On (b)(6) 2014, the false aneurysm was solved with the implantation of a covered stent (advanta v12 maquet) in the superficial femoral artery.Reportedly the results were very good.The patient tolerated the procedure.

Manufacturer Narrative

(b)(4).

• 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: joerg kersten ; 9285263030
• MDR Report Key: 5938727
• MDR Text Key: 54271908
• Report Number: 2017233-2016-00742
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2016
• Device Catalogue Number: PAC111002
• Device Lot Number: 12007165
• 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: 11/07/2013
• 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
• Treatment: (B)(4)
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 60 YR