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

Catalog Number	VBJR060202A
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/14/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2019, the patient was implanted with a gore® viabahn® endoprosthesis in the right common femoral artery to treat peripheral artery disease.It was reported a.014 command guidewire was used during the procedure.Reportedly, post balloon (7mm) dilation of the gore® viabahn® endoprosthesis the femoral artery pulse was lost.The physician stated is it unknown what caused the loss of pulse.The device was reportedly fully expanded prior to the identification of the loss of pulse in the femoral artery.It was reported an explant of the implanted gore® viabahn® endoprosthesis and endarterectomy were performed.The procedure was completed with no additional adverse events.The patient tolerated the procedure.
Additional Manufacturer Narrative
Added a1: patient identifier.
Additional Manufacturer Narrative
Added complainant address (country).Correction code 213 ¿ the review of the manufacturing paperwork verified that the lot met all pre-release specifications.
Additional Manufacturer Narrative
Corrected g5: combination product (yes).

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• Common Device Name: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9313074
• Report Number: 2017233-2019-01132
• Device Sequence Number: 13570004
• Product Code: PFV
• UDI-Device Identifier: 00733132623945
• UDI-Public: 00733132623945
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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,Followup,Followup,Followup
• Report Date (Section B): 01/10/2020

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: 01/29/2022
• Device Catalogue Number: VBJR060202A
• Device Lot Number: 20304109
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 11/12/2019
• Supplement Report FDA Received Date: 12/02/2019; 12/03/2019; 01/11/2020
• 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
• Patient Age: 59 YR
• Patient Weight: 79