MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE-TEX® VASCULAR GRAFT; PROSTHESIS, VASCULAR GRAFT

Model Number RRT08070080L

Device Problem Insufficient Information (3190)

Patient Problem Hematoma (1884)

Event Date 06/12/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Ifu statement: bleeding, bruise, or collection of blood around the graft, outside the blood vessel (perigraft hematoma).W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Event Description

It has been reported to gore that, on (b)(6) 2016 this patient underwent an endovascular repair of peripheral arterial disease located in the common femoral artery and was treated with a gore-tex vascular graft, the patient received heparin as an additional antiplatelet treatment.It was reported that the patient tolerated the procedure, it was also recorded that the procedure was uneventful, the device was implanted and retained and that the patient was discharged on (b)(6) 2016.On (b)(6) 2016 an adverse event termed: left inguinal hematoma surgery was reported.It was recorded in the registry that this adverse event is procedure-related, required an intervention/treatment and resolved without sequalae.

• Brand Name: GORE-TEX® VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL WEST B/P; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer Contact: wilson okeke ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15127853
• MDR Text Key: 296846711
• Report Number: 2017233-2022-03170
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00733132611102
• UDI-Public: 00733132611102
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K880167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/02/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2021
• Device Model Number: RRT08070080L
• Device Catalogue Number: RRT08070080L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/01/2022
• Initial Date FDA Received: 07/29/2022
• Supplement Dates Manufacturer Received: 11/01/2022
• Supplement Dates FDA Received: 11/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male