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

Model Number	VBHR091502A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/14/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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
On (b)(6) 2020, a gore® viabahn® endoprosthesis (vsx) was being placed as a fenestration device, in the mesenteric artery.The access was gained from the arm into the subclavian artery using a 8.8fr cook introducer sheath.After the physician accessed the mesenteric artery, he used a technique of retracting the sheath while deploying the device.When he thought the device was fully deployed, he attempted to remove the device catheter and felt some resistance.Under fluoroscopy it was noticed that the device had been pulled back into the aorta.The physician retracted the device to the introducer sheath and attempted to remove the device and sheath in tandem.However, when the device was being removed it had become deployed in the subclavian arch.The physician than had to perform a cut down procedure to remove the device.An additional vsx device was successfully deployed to complete the procedure.The patient tolerated the procedure.
Additional Manufacturer Narrative
A review of the manufacturing records indicated the lot met all pre-release manufacturing specifications.G4 - combination product? (if yes check box), corrected to yes.

• 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: 10554343
• Report Number: 2017233-2020-01271
• Device Sequence Number: 11373939
• Product Code: NIP
• UDI-Device Identifier: 00733132646005
• UDI-Public: 00733132646005
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• 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
• Report Date (Section B): 03/23/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/08/2022
• Device Model Number: VBHR091502A
• Device Catalogue Number: VBHR091502A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/14/2020
• Supplement Date Received by Manufacturer: 03/23/2021
• Initial Report FDA Received Date: 09/18/2020
• Supplement Report FDA Received Date: 03/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention