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

Catalog Number H060040

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem Aneurysm (1708)

Event Date 03/23/2020

Event Type  Injury  

Manufacturer Narrative

Patient identifier: no patient specific details have been provided.Therefore, the patient initials reflect the study number with codes for the hospital and patient.As the device remains implanted, no further investigation can be performed.Evaluation codes investigation findings c19 refers to the product history review: a review of the manufacturing- and heparin-coating records indicated the lot met all pre-release specifications.Neither images enabling direct assessment of product performance nor the product itself, which remains implanted, were returned for evaluation.The physician stated that the cause of bleeding was non-hemostasis of the graft puncture site and the cause of the pseudoaneurysm was bleeding from the graft puncture.In the instruction for use for the gore® propaten® vascular graft the following is stated: possible complications with the use of any vascular prosthesis complications which may occur in conjunction with the use of any vascular prosthesis include but are not limited to: excessive suture hole bleeding; formation of pseudoaneurysms due to excessive, localized, or large needle punctures heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.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

The following was reported to gore: on (b)(6) 2019, the patient underwent surgical treatment for the creation of a vascular access graft for hemodialysis with a gore® propaten® vascular graft.The device was implanted and retained.There were no adverse events during the procedure.It was dialyzed successfully through the graft on (b)(6) 2020.On (b)(6) 2020, a pseudoaneurysm was identified due to bleeding from a graft puncture and a secondary pseudoaneurysm, which required treatment.As reintervention a simple hemostatic graft suture with prolene in the device was performed the same day.The device patency was restored/maintained at the end of the procedure.

• Brand Name: GORE® PROPATEN® 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: gunter marte ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 16002666
• MDR Text Key: 305683585
• Report Number: 2017233-2022-03584
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): Y
• Reporter Country Code: SP
• PMA/PMN Number: K062161
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/13/2023
• Device Catalogue Number: H060040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/23/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/14/2019
• 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: 76 YR
• Patient Sex: Male