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

Model Number	VBHR110502A
Medical Device Problem Codes	Material Fragmentation (1261); Activation Problem (4042)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	04/22/2022
Type of Reportable Event	Death
Additional Manufacturer Narrative
Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium apl, which in covalently bound to the device surface and is essentially|non-eluting.
Event or Problem Description
The following information was provided to gore: on (b)(6) 2022, a gore® viabahn® endoprosthesis with propaten bioactive surface (vsx device) was intended for use in the popliteal artery for treatment of an aneurysm.After an 11mm x 10cm vsx device was successfully implanted, an additional 11mm x 5cm vsx device was to be implanted at the distal end of the first device.Reportedly the deployment line was difficult to pull and after a few attempts the deployment line came out.However, after an angiogram was performed, it was observed the deployment line broke and approximately half the vsx device remained constrained.The delivery catheter was pulled to the introducer sheath and the physician attempted to remove the sheath and catheter in tandem by pulling up and over the aortic bifurcation.However, the vsx device had become stuck at the incision site and a cut down was performed to removed the vsx device.After the vsx device was removed and the final sutures were 3 being placed, the patients vitals dropped and cardiopulmonary resuscitation (cpr) was performed.The patient was brought to the intensive care unit (icu) and placed on a ventilator.It was reported that the patients family took him off of life support and the patient expired.The physician suspected: the patient didn't expire due to device failure or blood loss.It was due to additional anesthesia dosing for device removal.Noted: both devices had difficulties advancing through a 10fr x 45cm ansel sheath.
Additional Manufacturer Narrative
Section h6 updated to reflect completion of investigation.Manufacturing records were reviewed, and the device met all pre-release specifications.The reported deployment difficulty with a broken deployment line was confirmed through evaluation of the images provided.The investigation could not confirm the cause of the reported hazardous situation nor the primary device failure mode with the available information, including evaluation of provided images.Cause of the reported event cannot be established based on evaluation of the images provided and the information reported to gore.Further information regarding this event was requested by gore, but no further information has been reported, therefore this investigation is considered complete.

• 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: nick lafave ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 14274269
• Report Number: 2017233-2022-02896
• Device Sequence Number: 4438974
• Product Code: NIP
• UDI-Device Identifier: 00733132646081
• UDI-Public: 00733132646081
• 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,Followup
• Report Date (Section B): 08/04/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/20/2022
• Device Model Number: VBHR110502A
• Device Catalogue Number: VBHR110502A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/22/2022
• Supplement Date Received by Manufacturer: 06/15/2022; 08/04/2022
• Initial Report FDA Received Date: 05/04/2022
• Supplement Report FDA Received Date: 06/15/2022; 08/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2019
• 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: Death; Hospitalization
• Patient Age: 82 YR
• Patient Sex: Male