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

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.

• 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 86001
• Manufacturer Contact: helen huang ; 1500 n. 4th street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 3811465
• MDR Text Key: 4681554
• Report Number: 2017233-2014-00249
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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,Followup
• Report Date: 07/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/20/2017
• Device Catalogue Number: VBC061502
• Device Lot Number: 11625668
• 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: 08/21/2012
• 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): Disability