Catalog Number VBC061502 |
Device Problems
Improper or Incorrect Procedure or Method (2017); Physical Resistance (2578); Malposition of Device (2616); Difficult to Advance (2920)
|
Patient Problems
Ischemia (1942); Occlusion (1984)
|
Event Date 03/20/2014 |
Event Type
Injury
|
Event Description
|
On (b)(6) 2014, the patient was treated for serious stenosis in the superficial femoral artery of the left limb by using a 6mm x 15cm gore® viabahn® endoprosthesis (item#: vbc061502, lot#: 11625668).It was reported that resistance was felt during advancement of the viabahn device inside the superficial femoral artery even after pre-dilation.An attempt was made to remove the device but the device failed to move.The patient experienced acute limb ischemia and was prepared for emergent conversion surgery.During preparation for surgery, the symptoms of ischemia turned severe.In the surgery the viabahn device was observed to be partially deployed in the distal end of the left femoral artery bifurcation.The proximal portion of the device was still constrained, which prevented blood flow to the femoral profounda artery and the left superficial femoral artery.It was reported to gore that an amputation of left limb was performed a couple of days after the conversion surgery due to severe ischemia.
|
|
Manufacturer Narrative
|
The review of the manufacturing records verified that this lot met all pre-release specifications.Per the gore® viabahn® endoprosthesis instructions for use (ifu), complications associated with the use of the gore® viabahn® endoprosthesis may include but are not limited to side branch occlusion.
|
|
Event Description
|
Received complaint by e-mail on (b)(4) 2014.On (b)(6) 2014, the patient was treated for a serious stenosis in the superficial femoral artery of the left limb by using a 6mm x 15cm gore viabahn endoprosthesis (item#: vbc061502, lot#: 10625668).It was reported that the physician felt a certain resistance during advancing the viabahn device inside the superficial femoral artery even after pre-dilation, the physician decided to retreat the device but failed to move the device.The patient experienced an acute limb ischemia and was taken an emergent conversion surgery.The viabahn device was reportedly deployed in the left femoral artery bifurcation and unintentionally covered the femoral profound artery.An amputation of left limb was reportedly done a couple of days after the conversion surgery due to ischemia.
|
|
Manufacturer Narrative
|
A review of the manufacturing paperwork is being conducted.
|
|
Search Alerts/Recalls
|