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 Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 information was reported to gore: on (b)(6) 2020, the patient was being treated for a stenotic lesion in the patient¿s superficial femoral artery using two gore® viabahn® endoprostheses.The first viabahn was advanced and implanted with no issue.The second viabahn was advanced and implanted successfully for distal extension.However, as the viabahn was being withdrawn from the patient the tip of the catheter reportedly separated from the catheter.The physician stated it is unknown what caused the separation of the catheter tip.The tip was still on the wire and was grabbed and removed from the patient¿s body with a snare device.The patient tolerated the procedure.
Additional Manufacturer Narrative
The engineering evaluation identified the following: the manufacturing records were reviewed, and the device lot met all pre-release specifications.This evaluation concludes the failure mode for this complaint is the distal tip bond was not created based on observation of the returned item and comparison with observation of known devices with good distal tip bonds.The cause of this process failure remains unknown.Corrected conclusion code.
Additional Manufacturer Narrative
Corrected section d1/d2.
Additional Manufacturer Narrative
The engineering evaluation identified the following: the manufacturing records were reviewed, and the device lot met all pre-release specifications.This evaluation concludes the failure mode for this complaint is the distal tip bond was not created based on observation of the returned item and comparison with observation of known devices with good distal tip bonds.The cause of this process failure remains unknown.H6.Corrected the conclusion code.

• 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: 10451372
• Report Number: 2017233-2020-01160
• Device Sequence Number: 20021747
• Product Code: NIP
• UDI-Device Identifier: 00733132623907
• UDI-Public: 00733132623907
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P040037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 06/30/2021

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: 05/15/2023
• Device Model Number: VBJR050502A
• Device Catalogue Number: VBJR050502A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/30/2020
• Supplement Date Received by Manufacturer: 05/07/2021; 05/21/2021; 06/28/2021; 06/30/2021
• Initial Report FDA Received Date: 08/25/2020
• Supplement Report FDA Received Date: 05/07/2021; 05/21/2021; 06/28/2021; 06/30/2021
• Patient Sequence Number: 1