MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	VBJR051502A
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Codes	Obstruction/Occlusion (2422); Insufficient Information (4580)
Date of Event	07/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional manufacturer narrative: cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.
Event or Problem Description
On an unknown date, the patient present with a non-healing ulcer.Additionally, computed tomography angiography identified thrombus and associated plaque in the proximal superficial femoral artery.It was noted there was not a complete occlusion.The guiding sheath was advanced up and over the bifurcation, however, it only reached the common femoral artery.The valve of the sheath was immediately adjacent to the access site.A atherectomy was performed with a distal filter in place.Next a balloon angioplasty of the lesion was performed.There was a residual clot and dissection around the location of the plaque.The physician decided to cover the locations using a gore® viabahn® endoprosthesis with heparin bioactive surface with a 1:1 sizing of device to vessel.The delivery catheter was advanced to its intended location with no issue.The physician slowly started pulling the deployment line and felt no resistance.The physician confirmed the catheter was oriented straight out of the catheter while pulling the deployment line.Halfway through the deployment the deployment line snapped.The stent graft remained partially deployed.The physician attempted to cut back the catheter to locate the deployment line.The deployment line was unable to be located.The sheath was then advanced as far as it would reach in an unsuccessful attempt to cover the device and remove it.The catheter was pulled back causing the stent graft to fully expand.The viabahn® device landed in front of the profunda and into the common femoral artery approximately 1.5cm.An unsuccessful attempt was made to use a balloon to push the stent graft distally away from the common femoral artery and the profunda.It was noted the flow from the profunda was still partially obstructed.In order to restore full blood flow to the profunda the physician performed a surgical cut down cutting off the proximal 1.5cm of the endoprosthesis and then tacked it down to the sfa.The physician noted when he took out that segment of the endoprosthesis there was a string attached to it.This was assumed to be a portion of the deployment line but was not confirmed.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 12334104
• Report Number: 2017233-2021-02278
• Device Sequence Number: 4542706
• Product Code: NIP
• UDI-Device Identifier: 00733132623921
• UDI-Public: 00733132623921
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P040037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/07/2021
• Device Model Number: VBJR051502A
• Device Catalogue Number: VBJR051502A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/20/2021
• Supplement Date Received by Manufacturer: 07/20/2021
• Initial Report FDA Received Date: 08/17/2021
• Supplement Report FDA Received Date: 10/04/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention