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

Catalog Number VBCR081501A

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Perforation (2001)

Event Date 04/07/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Review of device manufacturing record history confirmed device met pre-release specifications.The gore viabahn® endoprostheses were not returned; they remain implanted.Ifu method section states: proper placement of the endoprosthesis should be monitored and confirmed using fluoroscopy.Ifu warnings section states: special care should be taken to ensure that the appropriate size endoprosthesis, compatible sheath and guidewire are selected prior to introduction.Ifu directions for use state: guidewire length should be at least twice the length of the gore® viabahn® endoprosthesis delivery catheter.

Event Description

Patient presented with a venous outflow stenosis in the left forearm where a loop graft (unknown manufacturer) had previously been implanted.At the conclusion of an angioplasty procedure, the basilic vein had perforated.To exclude the perforation, an 8fr sheath was used to advance a gore® viabahn® endoprosthesis over a bentson wire.The gore® viabahn® endoprosthesis was implanted; however, the dissection propagated requiring another gore® viabahn® endoprosthesis to be placed.After the second device was placed, the dissection extended again.A third gore® viabahn® endoprosthesis was advanced and placed at targeted treatment site.It was reported that by this time, the third gore® viabahn® endoprosthesis appeared to be supported only by the floppy tip of the guidewire.About 1-2cm of the deployment line unraveled when the line got hung up and would not release.The catheter was being pulled back forcibly when the distal end of the gore® viabahn® endoprosthesis started expanding.As the distal tip of the catheter was pulled through the device, the gore® viabahn® endoprosthesis expanded to full deployment.It was reported that although fluoroscopy was used, the guidewire may have been in and outside of patient's vessel while devices were advanced and deployed.The patient was converted to surgery repair because the vein was compromised.The existing loop graft was detached from the gore® viabahn® endoprostheses and ligated.A gore® acuseal vascular graft was sewn to the ligated loop graft, and implanted from the cephalic to axillary vein.A gore® viabahn® endoprosthesis was placed inside the gore® acuseal vascular graft at the cephalic arch.No explants were performed and the patient was reported to be doing well after the procedure.

Manufacturer Narrative

Images received were not able to be manipulated in any way.Images provided do not allow for evaluation in relationship to this event.No conclusions can be drawn from this evaluation.

• 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: genevieve begay ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 5625736
• MDR Text Key: 45280211
• Report Number: 2017233-2016-00432
• 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: 04/28/2016

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
• Device Operator: Health Professional
• Device Expiration Date: 12/30/2017
• Device Catalogue Number: VBCR081501A
• Device Lot Number: 13532641
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/03/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/31/2014
• 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): Required Intervention
• Patient Age: 69 YR