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

Model Number	VBHR081002A
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
User facility voluntary event report #mw5095653.Review of device manufacturing record history review is in progress.The device remains implanted; therefore, direct product analysis is not possible.The plus antimicrobial product coating contains silver carbonate [approximately 800 micrograms per cubic centimeter of product (g/cm3)], and chlorhexidine diacetate [approximately 1600 micrograms per cubic centimeter of product (g/cm3)].
Event or Problem Description
On (b)(6) 2020, a patient was being treated in an emergent case due to a right-side retroperitoneal bleeding.As reported, the patient's vessels were heavily calcified.Using a short 8fr sheath (unknown brand), a gore® 8mm x 10cm viabahn® endoprosthesis (viabahn device) was advanced over a wire from the contralateral side to treat the right external iliac artery.However, the sheath and viabahn device got caught on the calcification.At this time, the viabahn device unexpectedly 'self-deployed' in the left external iliac artery.A balloon was inserted and an angioplasty was performed within the viabahn device.The short 8fr sheath was then exchanged for a long 8fr sheath.A second viabahn device (8mm x 10cm) was advanced over the wire into the right external iliac artery.It was deployed under fluoroscopy with no issues.
Additional Manufacturer Narrative
This medwatch report is being retracted as the event / complaint is a duplicate.Medwatch report number 2017233-2020-01143 was submitted previously to report this event / complaint.

• 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: 10466157
• Report Number: 2017233-2020-01191
• Device Sequence Number: 11423726
• Product Code: NIP
• UDI-Device Identifier: 00733132623136
• UDI-Public: 00733132623136
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• 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: user facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2020

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: 06/02/2022
• Device Model Number: VBHR081002A
• Device Catalogue Number: VBHR081002A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/31/2020
• Supplement Date Received by Manufacturer: 07/31/2020
• Initial Report FDA Received Date: 08/28/2020
• Supplement Report FDA Received Date: 10/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 89 YR
• Patient Weight: 68