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

Catalog Number	VBH101502A
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The fsa provided the following information: on october 30, 2019, it was reported a gore® viabahn® endoprostheses was implanted.It was reported a 12 fr gore® dryseal flex introducer sheath was used during the procedure.Reportedly, the device became stuck while passing through a previously implanted dacron graft used to repair a femoral artery aneurysm.It was reported the physician attempted to withdraw the device into the sheath, however, the device could not be removed.The device was deployed within the aneurysm proximal to the intended seal zone.The patient was implanted with two gore® viabahn® endoprostheses in their intended location within the femoral artery.It was reported the devices successfully excluded the aneurysm.It was reported the physician then performed a surgical conversion to explant the initial device from the femoral artery.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• Common Device Name: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9379678
• Report Number: 2017233-2019-01190
• Device Sequence Number: 2159337
• Product Code: PFV
• UDI-Device Identifier: 00733132623235
• UDI-Public: 00733132623235
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P040037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/30/2019

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: 11/11/2021
• Device Catalogue Number: VBH101502A
• Device Lot Number: 20070238
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/26/2019
• 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; Required Intervention