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

Model Number	VBJR070502A
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2021
Type of Reportable Event	Serious Injury
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
The following was reported to gore: on (b)(6) 2021, a patient presented with stenosis in the left external iliac artery and underwent treatment utilizing a gore® viabahn® endoprosthesis with heparin bioactive surface device.The patient was undergoing a left kidney bypass with an open cut down over the left femoral artery.During the kidney bypass, the physician also intended to place a viabahn device in the left external iliac artery to treat a stenotic lesion.The viabahn device was successfully deployed across the lesion without issue.The physician then attempted to pass the sheath through the viabahn device, at which point its reported that the sheath grabbed the edge of the implanted endoprosthesis and pushed it forward and into the kidney bypass by approximately 2cm.The physician attempted to reposition the viabahn device by inserting a balloon and pulling the device back into place, but was unsuccessful.Because there was already a left femoral cut down as part of the kidney bypass, the physician decided to extend the cut down a bit higher and manually retrieve the viabahn device.This method was successful and the malpositioned device was explanted from the patient without further issue.The patient tolerated the procedure and is reported to be doing well.
Additional Manufacturer Narrative
Updated h6 to reflect completion of the investigation.

• 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
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: kaitlin barnash ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12623751
• Report Number: 2017233-2021-02466
• Device Sequence Number: 16999503
• Product Code: NIP
• UDI-Device Identifier: 00733132623761
• UDI-Public: 00733132623761
• Combination Product (Y/N): Y
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P040037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2022

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: 09/13/2023
• Device Model Number: VBJR070502A
• Device Catalogue Number: VBJR070502A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2021
• Supplement Date Received by Manufacturer: 09/17/2021
• Initial Report FDA Received Date: 10/13/2021
• Supplement Report FDA Received Date: 01/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 66 YR
• Patient Sex: Female