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

Catalog Number	HT064050A
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/06/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the manufacturing 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 further investigation is possible.All information has been placed on file for use in tracking and trending.
Event or Problem Description
The following was reported to gore by the hospital operating room supervisor: the gore® propaten® vascular graft with heparin was implanted (b)(6) 2018 in the lower extremity during a femoral-femoral crossover procedure.The supervisor reported that on (b)(6) 2018, because of a non-healing surgical wound, the doctor suspected the graft was infected.The gore® propaten® vascular graft with heparin was explanted on (b)(6) 2018.The or supervisor reported cultures were taken during the explant procedure.
Additional Manufacturer Narrative
Additional manufacturer narrative: the hospital confirmed that both the bacterial culture and the fungus culture were negative.Patient identifier, age or date of birth, sex, weight and ethnicity- patient information other relevant history, including preexisting medical conditions(e.G., allergies, race, pregnancy, smoking and alcohol use, hepatic/renal sysfunction, etc.) corrected data: conclusions code.
Additional Manufacturer Narrative
Corrected data: b3: date of event.

• Brand Name: GORE PROPATEN VASCULAR GRAFT
• Common Device Name: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 7739423
• Report Number: 2017233-2018-00475
• Device Sequence Number: 1049837
• Product Code: DSY
• UDI-Device Identifier: 00733132606603
• UDI-Public: 00733132606603
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K062161
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/30/2018

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: 11/07/2021
• Device Catalogue Number: HT064050A
• Device Lot Number: 5751066PP008
• 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: 08/01/2018
• Supplement Report FDA Received Date: 08/10/2018; 08/31/2018
• 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: Required Intervention
• Patient Age: 87 YR
• Patient Weight: 70