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

Catalog Number H060040

Device Problems Obstruction of Flow (2423); Patient-Device Incompatibility (2682)

Patient Problem Ischemia (1942)

Event Date 05/02/2016

Event Type  Injury  

Manufacturer Narrative

No patient specific details have been provided.Therefore, the patient identifier reflect the study no.With hospital and patient.A product history review will be performed.Other code: as the device remains implanted, a further investigation cannot be performed.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) 2014, the patient underwent surgical treatment for the creation of a brachial-brachial vascular access graft in the left arm for hemodialysis with a gore® propaten® vascular graft.The device was implanted and retained and successfully used on (b)(6) 2014.On (b)(6) 2016, the patient presented with left hand ischemia due to fistula steal syndrome, which required medical or surgical intervention.On (b)(6) 2016, a repeat intervention was performed, namely a graft ligation within the study device.The device was abandoned as part of the reintervention.The patient tolerated the procedure and was discharged home the same day.

Manufacturer Narrative

H6 evaluation codes investigation findings c19 refers to the product history review: a review of the manufacturing- and sterilization records indicated the lot met all pre-release specifications.As the device remains implanted, no further investigation of the device can be performed.Neither clinical images enabling direct assessment of product performance, nor the device was returned for evaluation.Further information was requested and received from the physician, which was considered in the description summary.The physician believes that the av graft caused an ischemia of the hand (steal syndrome) that produced the bad evolution of the ulcer.It was necessary to ligate the av graft to ensure subsequent healing of the finger amputation.With the information provided to gore, the cause of the reported event cannot be established.H6 evaluation codes medical device problem code a1409 obstruction of flow was chosen by mistake in the initial report and has to be retracted.

• 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: 16617270
• MDR Text Key: 312012705
• Report Number: 2017233-2023-03817
• 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,Followup
• Report Date: 08/30/2023

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: 01/31/2018
• Device Catalogue Number: H060040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2023
• Initial Date FDA Received: 03/27/2023
• Supplement Dates Manufacturer Received: 08/10/2023
• Supplement Dates FDA Received: 08/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/13/2014
• 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: 55 YR
• Patient Sex: Female