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

Catalog Number VBH080501

Device Problems Unintended Collision (1429); Device Damaged by Another Device (2915); Device Dislodged or Dislocated (2923)

Patient Problem No Code Available (3191)

Event Date 04/03/2014

Event Type  Injury  

Event Description

A gore viabahn endoprosthesis and two everflex bare metal stents were used for the treatment of high-grade stenosis in the left common iliac and right superficial femoral artery (sfa).The endoprosthesis was advanced retrograde over a.035" storq guidewire and deployed in the left common iliac artery without incident.Following deployment, the endoprosthesis was post dilated with an 8mm x 4cm balloon.The first everflex bare metal stent was advanced via left contralateral approach over the storq guidewire and deployed in the right sfa without incident.Following deployment, the bare metal stent was post-dilated with a 6mm x 4cm mustang balloon.The second everflex bare metal stent was advanced via left contralateral approach over the storq guidewire and deployed in the right sfa.However, while attempting to advance the same 6mm x 4cm mustang balloon to post-dilate the second everflex bare metal stent, the balloon and storq guidewire was advanced several centimeters above the aortic abdominal bifurcation and into the abdominal aorta.Unable to visualize the location of the mustang balloon and storq guidewire, the physician encountered an increase in resistance during advancement.The.035¿ storq guidewire had kinked inside the previously deployed endoprosthesis located in the left common iliac artery.The kinked storq guidewire became entangled inside endoprosthesis.In attempt remove the guidewire from the endoprosthesis, the physician pulled the guidewire harder which dragged the deployed endoprosthesis, guidewire and 8 french sheath out of the left common iliac artery, into the left common femoral artery and removed from the left groin access site.Once the endoprosthesis, storq guidewire and sheath were removed from the common femoral artery, the endoprosthesis appeared completely destroyed.Images confirmed all components of the endoprosthesis were removed from the patient.The.035" storq guidewire kink eventually broke at the kink when the physician removed the wire out of the patient.After removal of the endoprosthesis, angiogram revealed no flow from the ostium of the left iliac artery all the way to where the end of the sheath stopped in the left external iliac artery.A left common lilac artery dissection was observed.A 9 french sheath was inserted into the patients groin and a 8mm x 10cm gore viabahn endoprosthesis was then deployed in the left common iliac artery to restore flow in the left common iliac artery.The patient was then transferred to the operating room.The vascular surgeon performed an endarterectomy, surgically repaired the left common iliac artery dissection and deployed another stent.The patient had a dorsalis pedis artery pulse.The patient was reported to be fine post procedure.

Manufacturer Narrative

Review of the manufacturing paperwork has been conducted.The review of the manufacturing paperwork verified that this lot met all pre-release specifications.Investigation is progress pending the return and evaluation of the endoprosthesis.

Manufacturer Narrative

Review of the manufacturing paperwork has been conducted.The review of the manufacturing paperwork verified that this lot met all pre-release specifications.Device returned and evaluated.Mechanical problem resulted from internal/external force(s) of the guidewire.

• 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: roger smith ; 1500 n. 4th street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 3784632
• MDR Text Key: 4443080
• Report Number: 2017233-2014-00225
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 05/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2016
• Device Catalogue Number: VBH080501
• Device Lot Number: 11922092
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2014
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/06/2013
• 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: CORDIS .035" STORQ GUIDEWIRE
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR
• Patient Weight: 75