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

Device Problems Contamination (1120); Microbial Contamination of Device (2303)

Patient Problems Bacterial Infection (1735); Unspecified Infection (1930); Inflammation (1932); Thrombosis/Thrombus (4440)

Event Date 11/17/2023

Event Type  Injury  

Manufacturer Narrative

A1: no patient specific details have been provided.Therefore, the patient initials reflect the w.L.Gore internal case number.A review of the manufacturing records for the device could not be conducted because the serial/lot number remains unknown.H6 evaluation codes type of investigation b13: additional information in regard to the event of the case was requested from the physician, but not provided yet.H3: other code: the medical device returned to a third party for further investigation.The analysis report was shared with gore and was evaluated appropriately.Explant scientist observations: the graft fragment was reported to measure 125 mm (length) and 5-7 mm (diameter) with both ends transected.The ablumen was generally devoid of tissue except for scant areas of dark brown and yellow tissue.The abluminal surface appeared yellow brown.The observable lumen ends were generally devoid of tissue.However, the majority of the lumen was generally unobservable.The patency of the graft fragment could not be determined based on the analysis or images provided.Material disruptions (e.G., transections) were consistent with those caused by surgical instrumentation (e.G., scalpel, scissors) used during a surgical procedure.No information was provided to confirm the presence or absence of the reported infection and no determination can be made from the provided information.Further investigation is being conducted and will be included in the final report.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

It was reported to gore that the patient underwent surgical treatment for a lower limb ischemia with a gore® propaten® vascular graft.It was stated that the vascular graft was implanted on (b)(6), 2022, to treat a lower limb ischemia.On (b)(6), 2023, after about one year and three months, the prosthesis was explanted due to an infection.

Manufacturer Narrative

With the available information, we are unable to determine the cause of this incident and assign a root cause.The physician stated that the cause for the infection was autologous and that there was no contribution or cause of the gore® propaten® vascular graft or the procedure to implant the device.In the instruction for use for the gore® propaten® vascular graft the following is stated: adverse events, potential device or procedure-related adverse events, complications which may occur in conjunction with the use of any vascular prosthesis and/or vascular or related procedures include but are not limited to: infection.

Event Description

It was reported to gore that the patient underwent surgical treatment for a lower limb ischemia with a gore® propaten® vascular graft.It was stated that the vascular graft was implanted as a bypass between femoral artery and the anterior tibial artery, in (b)(6), 2022, to treat a lower limb ischemia.On (b)(6) 2023, after about one year and three months, the prosthesis was explanted due to an infection with staphylococcus aureus.The graft gradually thrombosed and inflammation was diagnosed.The explanted device was replaced with an autologous saphenous vein.The patient tolerated the procedure and was discharged home.The physician stated that the cause for the infection was autologous and that there was no contribution or cause of the gore® propaten® vascular graft or the procedure to implant the device.

• 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: 18604229
• MDR Text Key: 334023546
• Report Number: 2017233-2024-04574
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): Y
• Reporter Country Code: FR
• PMA/PMN Number: K062161
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 74 YR
• Patient Sex: Male