MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE PROPATEN VASCULAR GRAFT; PROSTHESIS, VASCULAR GRAFT

Catalog Number	H470045A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is on-going.
Event or Problem Description
The following was reported to gore: the gore® propaten® vascular graft was implanted on (b)(6) 2019 in the groin.On (b)(6) 2019 the device was explanted because of infection.
Additional Manufacturer Narrative
Additional manufacturer narrative: review of the manufacturing and sterilization records verified that the lot met release requirements.The device was not returned.Consequently, a direct product analysis was not possible.Additional information about this event could not be obtained.As a result, no conclusion can be drawn.All information has been placed on file for use in tracking and trending.
Additional Manufacturer Narrative
Corrected data: h6.Results code 1.H6.Conclusions code 1.

• Brand Name: GORE PROPATEN VASCULAR GRAFT
• Common Device Name: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9158382
• Report Number: 2017233-2019-00994
• Device Sequence Number: 2151761
• Product Code: DSY
• UDI-Device Identifier: 00733132605958
• UDI-Public: 00733132605958
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K062161
• 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
• Report Date (Section B): 12/04/2019

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: 07/11/2022
• Device Catalogue Number: H470045A
• Device Lot Number: 5992406PP013
• 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
• Initial Report FDA Received Date: 10/04/2019
• Supplement Report FDA Received Date: 10/16/2019; 12/04/2019
• 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: Required Intervention