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

Model Number	VBHR071002A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2022
Type of Reportable Event	Malfunction
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) 2022, a patient underwent treatment utilizing a gore® viabahn® endoprosthesis with heparin bioactive surface (viabahn device) during an aaa case with hypogastric preservation bilaterally.The physician gained access with a right sided groin puncture and inserted a 9 fr terumo pinnacle® sheath up and over the aortic bifurcation to reach the left hypogastric artery.The viabahn device was loaded onto an amplatz wire with intention to track to the distal internal iliac artery.The physician was experiencing difficulty advancing the viabahn device up and over the aortic bifurcation due to patient tortuosity, and was applying quite a bit of force to get the viabahn device to track.While manipulating the catheter back and forth to aid advancement, the physician pulled the viabahn device back and the endoprosthesis accordioned on the proximal end.The catheter then broke off at the transition of the catheter and the viabahn device.The physician saw the exposed deployment line and cut the line, added a hemostat to maintain control, and pulled the viabahn device off of the catheter.The viabahn remained constrained, but was unable to be pushed or moved.The physician then inserted a balloon in an attempt to push the viabahn device and catheter piece further into the internal iliac artery, and was able to reposition the viabahn device to the intended area of treatment.The physician then pulled the deployment line and was able to successfully deploy the viabahn device in the treatment zone.A gooseneck snare was introduced in the right side groin access site and the physician was able to capture and remove the remaining catheter and device tip from the patient.The case proceeded without further issue and there were no reported adverse impacts to the patient.After removal, the physician verified the length of the deployment line fragments and confirmed all device fragments had been removed from the patient.
Additional Manufacturer Narrative
A review of the manufacturing records indicated the device lots met all pre-release specifications.The investigation included evaluation of returned components of the device: the dual lumen catheter attached to the hub assembly was returned detached from the distal shaft and tip and from the deployment knob.The endoprosthesis was not returned which is consistent with reported event details that the stent was successfully deployed in the intended treatment location.Based on the condition of the returned catheter with the end of the distal shaft frayed, there was no indication of a defective or missing bond between the distal shaft and the dual lumen.The observation of a detached distal shaft with a frayed proximal end and a cut deployment line attached to the knob are consistent with reported details indicating procedural difficulties.The gore® viabahn® endoprosthesis with heparin bioactive surface instructions for use (ifu) instructs the following with respect to device introduction and positioning: ¿using fluoroscopic guidance, advance the delivery catheter over the guidewire via the angiographic sheath.Advance cautiously, especially if resistance is felt.If excessive resistance is felt, remove the delivery catheter and sheath together.¿.

• 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: 14373681
• Report Number: 2017233-2022-02920
• Device Sequence Number: 19328696
• Product Code: NIP
• UDI-Device Identifier: 00733132622986
• UDI-Public: 00733132622986
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P040037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/11/2024
• Device Model Number: VBHR071002A
• Device Catalogue Number: VBHR071002A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2022
• Supplement Date Received by Manufacturer: 04/22/2022
• Initial Report FDA Received Date: 05/12/2022
• Supplement Report FDA Received Date: 06/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2021
• 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
• Patient Age: 75 YR
• Patient Sex: Male