MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE VIABAHN® ENDOPROSTHESIS - 3; NIP

Catalog Number	VBH101002A
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	07/20/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
The following information was reported to gore: on (b)(6) 2018 a patient was undergoing endovascular treatment of an abdominal aortic aneurysm.Adjunctively the patient was intended to be treated with a gore® viabahn® endoprosthesis for a heavily calcified external iliac artery stenosis.The device was advanced over a.035¿ amplatz wire through an 18fr sheath to the target location.When deployment was initiated, the middle section of the endoprosthesis expanded, while the proximal and distal sections remained constrained, since there was a large sheath in place, it was decided it may be possible to remove this device.When the device was pulled back, the distal end began expanding.At this point the device was partially outside of the patient¿s body, in the likeness of a conduit.It was then possible to advance another viabahn, inside, to connect to the leading end of the first device to complete the treatment.The endoprosthesis segment that was outside of the body was cut off.The access site was repaired with a cardiovascular patch and the groin incision was closed.The patient tolerated the procedure.
Additional Manufacturer Narrative
H.6.Results code 2: 213: the engineering evaluation stated the following: the following observations were made: the delivery catheter and a guidewire were returned.The guidewire was not evaluated because it is not a gore device.No endoprosthesis was returned.There was columnar failure of approximately 4.5 cm in length that was 55 cm from the hub.The remainder of the device was unremarkable.Engineering evaluation conclusion is inconclusive as it relates to the event description.Based on the device examination performed, no manufacturing anomalies were identified.

• Brand Name: GORE VIABAHN® ENDOPROSTHESIS - 3
• Common Device Name: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 7758628
• Report Number: 2017233-2018-00492
• Device Sequence Number: 1756865
• Product Code: PFV
• UDI-Device Identifier: 00733132623228
• UDI-Public: 00733132623228
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P040037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/05/2018

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: 07/05/2020
• Device Catalogue Number: VBH101002A
• Device Lot Number: 17264427
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 08/07/2018
• Supplement Report FDA Received Date: 09/04/2018; 09/08/2018
• 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
• Patient Age: 82 YR
• Patient Weight: 100