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

Model Number	VBH130502A
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/14/2021
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.Review of manufacturing record history confirmed device met pre-release specifications.Device remains implanted.Therefore, direct product analysis is not possible.
Event or Problem Description
The following was reported to gore: during treatment in the superior vena cava, access was made from the groin area.After sheath placement, a gore® viabahn® endoprosthesis with heparin bioactive surface (vsx device) was delivered to the treatment area.Deployment was initiated and the vsx device expanded about halfway when deployment stopped.As reported, the physician made attempts to complete the deployment by pulling steadily on the line.However, the deployment line broke.Access was then made from the axillary artery and a balloon catheter was delivered to the treatment site.The balloon was inflated and the vsx device expanded completely.The procedure ended with good results.The patient tolerated the procedure.
Additional Manufacturer Narrative
The device remains implanted; therefore, direct product analysis could not be conducted.However, an engineering evaluation was conducted: the manufacturing records were reviewed, and the device lot met all pre-release specifications.The cause of the stuck deployment line cannot be established because the endoprosthesis was not returned.There are potential design and process failure modes considered for possible cause contribution, but there are no data to either confirm or dismiss them as cause of the stuck deployment line.The broken deployment line is a probable result of the physician continuing to apply traction to the stuck deployment line as described in the complaint.The following were requested but not made available: patient dob or age; gender, weight, relevant medical history.

• 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
• MDR Report Key: 11314726
• Report Number: 2017233-2021-01664
• Device Sequence Number: 2737143
• Product Code: NIP
• UDI-Device Identifier: 00733132623280
• UDI-Public: 00733132623280
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P040037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2021

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: No Information
• Device Expiration Date: 06/24/2021
• Device Model Number: VBH130502A
• Device Catalogue Number: VBH130502A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/14/2021
• Supplement Date Received by Manufacturer: 01/14/2021
• Initial Report FDA Received Date: 02/11/2021
• Supplement Report FDA Received Date: 03/31/2021
• Patient Sequence Number: 1