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

Catalog Number JHJR052502J

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Dehydration (1807); Unspecified Infection (1930); Ischemia (1942); Occlusion (1984); Pneumonia (2011); Sepsis (2067); Fasciitis (2375)

Event Date 02/15/2017

Event Type  Death  

Manufacturer Narrative

The review of the manufacturing and sterilization 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: infection and death.(b)(4).

Event Description

The following was reported to gore: this patient admitted for intractable ulcer in the left lower leg (rutherford stage 6).The patient had also deep vein thrombosis.Endovascular procedure or major amputation was considered, and endovascular procedure was chosen per the family¿s request.On (b)(6) 2016, the patient underwent endovascular procedure.Angiography showed complete occlusion from the left superficial femoral artery to the left popliteal artery.A left superficial femoral artery aneurysm (measured over 20 mm) was also confirmed by pre-procedure computed tomography (ct).Therefore, the physician considered the aneurysm caused the embolic occlusion.Two gore® viabahn® endoprostheses were implanted to repair the occlusion with the aneurysm.The endoprostheses were located from the left superficial femoral artery to the distal left popliteal artery (p3 segment).It was reported that there was only one-run off vessel.Non-gore stent (epic) was implanted in the left external iliac artery.The patient tolerated the procedure.The physician reportedly said that the endovascular procedure was successfully completed, and good patency was observed after the procedure.On (b)(6) 2017, lisfranc amputation was performed in the left leg as planned.On (b)(6) 2017, split thickness skin grafting was performed for the amputated portion.Wound treatment was continued, and a condition of the skin was reportedly well.On unknown date, it was reported that the patient developed pneumonia which led to dehydration.On (b)(6) 2017, skin color of the grafted portion was not well.Acute ischemia of the left lower leg was suspected.On the same day, the physician elected to perform emergent revascularization.It was confirmed that the left superficial femoral artery was completely occluded, and thrombus aspiration was performed.A sheath was left in a place and continuous infusion of urokinase was performed.After that, ct showed emphysema in the left thigh.A diagnosis of necrotizing fasciitis was made.(the physician also reported this as gas gangrene.) on the same day, emergent above-knee amputation in the left leg was performed.Intensive care was continued, however, it was difficult to control the infection.On (b)(6) 2017, the patient developed sepsis and expired.Autopsy was not performed.The physician considered the sepsis and the patient's death were not caused by the endoprosthesis.

• 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: saori kawai ; 9285263030
• MDR Report Key: 6412312
• MDR Text Key: 70171188
• Report Number: 2017233-2017-00130
• 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: 02/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/02/2019
• Device Catalogue Number: JHJR052502J
• Device Lot Number: 15748181
• 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: 05/02/2016
• 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): Death
• Patient Age: 79 YR