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

Model Number	VBJR050502A
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	Intimal Dissection (1333)
Date of Event	10/27/2020
Type of Reportable Event	Malfunction
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 was reported to gore: the physician had left common femoral artery(cfa) access and wanted to go up and over to the right to treat the external iliac artery.The physician attempted to bareback a 5x5cm gore® viabahn® endoprosthesis with heparin bioactive surface(vsx) up and over the bifurcation through a short 6fr x 10cm pinnacle sheath on a v-18 wire.It was observed that on the right side was a right common iliac stent right at the aortic bifurcation.The viabahn stent became stuck on the old right common iliac stent and when the physician attempted to apply more pressure the viabahn stent catheter appeared to either get kinked or stuck on the wire.Attempts were made to remove the device, and were unsuccessful.At some point the stent catheter fractured and the stent portion along with the deployment string separated from the rest of the catheter.At this point the physician gained right cfa access and inserted an 8fr sheath to attempt retrieval.A 10mm ensnare was used to capture the stent.The stent would not track through the 8fr sheath so the doctor pulled the sheath and stent out in tandem.Removal was successful.The physician decided to insert another viabahn (b)(4) through the right cfa and successfully deployed and completed the case.Patient harm: it was noted that a dissection of the right cfa occurred at some point during the retrieval or removal of the 8fr sheath.The doctor consulted with a vascular surgeon who believes the cfa should be fine.Upon follow-up with the patient on (b)(6) 2020, the right cra dissection still existed but did not appear to be flow limiting.It is not believed that further action will be taken, and the patient should heal fine.
Additional Manufacturer Narrative
H6: 213 code, a review of the manufacturing records confirmed the lot met pre-release manufacturing specifications.
Additional Manufacturer Narrative
Updated patient age and gender.H6 - investigation conclusions, updated code to 4311 (adverse event related to procedure) and 61 (unintended use error caused or contributed to event).

• 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: 10864641
• Report Number: 2017233-2020-01460
• Device Sequence Number: 2863249
• Product Code: NIP
• UDI-Device Identifier: 00733132623907
• UDI-Public: 00733132623907
• Combination Product (Y/N): Y
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P040037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/22/2021

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: 03/02/2022
• Device Model Number: VBJR050502A
• Device Catalogue Number: VBJR050502A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/05/2020
• Supplement Date Received by Manufacturer: 09/02/2021; 11/22/2021
• Initial Report FDA Received Date: 11/18/2020
• Supplement Report FDA Received Date: 09/02/2021; 11/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2019
• 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
• Patient Age: 69 YR
• Patient Sex: Male