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

Catalog Number HT060080

Device Problems Complete Blockage (1094); Microbial Contamination of Device (2303)

Patient Problems Bacterial Infection (1735); Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)

Event Date 07/19/2022

Event Type  Injury  

Manufacturer Narrative

H6-b13: additional information to the event, the infection, and treatment modalities have been requested from the physician.The answers are captured in section b5.H6-b14 and c19: a review of the manufacturing records indicated the lot met all pre-release specifications.H6-b15 and b17 and h3-other: the physician has sent the explanted device to an independent 3rd party for evaluation.Investigation (macroscopic and microscopic analysis of the explanted vascular graft after cleaning) was performed by the third party.The explanted device was not returned to gore for evaluation.Instead, they provided analysis results to gore, which are being reviewed by gore explant scientists.Cbas® 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, on (b)(6), 2021, the patient presented with a critical limb threatening ischemia in the left femoral artery has been treated with a gore® propaten® vascular graft.On (b)(6), 2022, the leg was amputated and the graft was explanted due to graft thrombosis and infection.It was reported that a local gram-negative bacillus infection (not further specified) was diagnosed at the stump.Reportedly the thrombosed graft was contaminated as well.It was reported that the patient could be discharged home without further complications.

Manufacturer Narrative

Cause investigation and conclusion the physician has sent the explanted devices to an independent 3rd party for evaluation.The 3rd party provided gore with their macroscopic analysis results of the explanted devices.A request was sent to the 3rd party to further clarify the event.The answer is captured in section 3.A review of the manufacturing records indicated the lot met all pre-release specifications.The device enabling direct assessment of product performance was not returned to gore for evaluation.The analysis results provided by the 3rd party were reviewed by gore explant scientists.The explant evaluation summary stated the following: the graft fragment was reported to measure 160 mm in length with both ends transected.The abluminal surface was covered with minimal, scattered plaques of red-brown material and the blue alignment marks were faintly visible.There are evenly spaced serration marks visible near one of the extremities on the abluminal surface of the graft fragment.The visible portions of the lumen at both extremities contained minimal scant plaques of red-brown biologic material.The patency of the graft fragment cannot be confirmed based on the analysis or images provided.From gross images all material disruptions (i.E., material transections/cuts), appear to be consistent with cutting by sharp surgical instruments (i.E., scalpel or scissors) and grasping/pulling with surgical instrumentation (i.E., hemostat/clamps), likely used during a surgical procedure.No additional analysis of the explanted device was requested as it would only confirm the presence of infection with no additional information provided for the role of the device.The evaluation found no anomalies attributable to the manufacture of the device.The identity of the device in the case images provided within the 3rd party report appears to be consistent with the device described in the complaint but could not be confirmed.Neither the incident description nor the occlusion/thrombosis of the device could not be confirmed with the provided information.Based on the incident description and the subsequent investigation, no further information was provided to gore, we are unable to determine the cause of this incident and assign a root cause.Reported device occlusion and infection represents a known complication or adverse event that can occur when using vascular prosthesis and can arise as a result of a multitude of factors, including intraprocedural technical considerations, post-operative follow-up and treatment regimen, patient-related risk factors and disease progression.No allegation of device malfunction was indicated with respect to device performance.The gore® propaten® vascular graft instructions for use (ifu), for the appropriate region and time-period, was reviewed with respect to the complaint detail and there are applicable statements.The ifu states the following: 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; thrombosis.

• 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: sibylle staerk ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17628922
• MDR Text Key: 322022529
• Report Number: 2017233-2023-04233
• 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: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: HT060080
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2020
• 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): Hospitalization; Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male