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

Catalog Number HT0845050

Device Problems Microbial Contamination of Device (2303); Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 06/05/2023

Event Type  Injury  

Manufacturer Narrative

Cbas® heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.A4: patient weight was requested, but not made available.H6 - code b15: from gepromed report - the explanted graft is covered by thick overlying tissue which hampers the level of macroscopic analysis of the eptfe material.H6 - code b22: device lot/serial number was requested, but not made available.Therefore, review of device manufacturing record history could not be conducted.H6 - code b17: the explanted graft was not returned to gore for further examination.The explant remains with gepromed (strasbourg france).Further investigation was not possible and there was no confirmation of infection based on third party analysis.Ifu for gore® propaten® vascular graft possible complications with the use of any vascular prosthesis a.Complications which may occur in conjunction with the use of any vascular prosthesis include but are not limited to: infection.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 obtained from a third party report: on (b)(6) 2023, a gore® propaten® vascular graft was implanted to treat ischemia.The implant is believed to be in the femoropopliteal region, based on patient's history of multiple graft implants, revisions and interventions.On (b)(6) 2023.The gore® propaten® vascular graft was explanted due to an unspecified infection.It is unknown if the infection was associated with the vascular graft.At the time of the explant, cardiovascular risk factors of the patient were hypertension, dyslipidemia and active smoking.Further information was requested from gepromed, but no details were provided.

Manufacturer Narrative

H6 - code b15: an explant scientist at w.L.Gore & associates reviewed the report provided from 3rd party (b)(4): due to inability to visualize a single blue line to indicate a gore vascular graft, the device type could not be confirmed.The graft fragment was reported to measure 232 mm in length with both ends transected.The albumen of the graft was covered in thick, scattered plaques of light tan to dark red biologic material, and the removable rings were visible.Two blue monofilament sutured areas (presumptive anastomosis) were observed.Scant plaques of yellow biologic material were present on the abluminal surface.The lumens of the fragment were partially occupied with dark red to brown tissue.No saline patency test was noted to have been performed, therefore the patency of the graft fragment could not be confirmed based on the analysis or images provided.Material disruptions (e.G., transections, suture) were consistent with those caused by surgical instrumentation (e.G., scalpel, scissors, suturing needles) during the surgical or explant process.No information was provided to confirm the presence or absence of the reported infection and no determination can be made from the provided information.

Manufacturer Narrative

D6a: corrected implant date.

Manufacturer Narrative

B5: description was updated.Reason for treatment was aneurysm (lower limb bypass) using a gore® propaten® vascular graft.

Event Description

The following was obtained from a third party report: on (b)(6) 2023, a gore® propaten® vascular graft was implanted to treat an aneurysm.The implant is believed to be in the femoropopliteal region, based on patient's history of multiple graft implants, revisions and interventions.On (b)(6) 2023.The gore® propaten® vascular graft was explanted due to an unspecified infection.It is unknown if the infection was associated with the vascular graft.

• 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: genevieve begay ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18000231
• MDR Text Key: 326448152
• Report Number: 2017233-2023-04351
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): Y
• Reporter Country Code: SZ
• PMA/PMN Number: K062161
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/19/2024

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 Catalogue Number: HT0845050
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/04/2023
• Initial Date FDA Received: 10/24/2023
• Supplement Dates Manufacturer Received: 10/04/2023; 10/04/2023; 01/30/2024
• Supplement Dates FDA Received: 11/30/2023; 01/19/2024; 02/19/2024
• 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: 73 YR
• Patient Sex: Male