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

Catalog Number IRTH084040

Device Problem Microbial Contamination of Device (2303)

Patient Problem Bacterial Infection (1735)

Event Date 02/06/2023

Event Type  Injury  

Event Description

It was reported to gore that the patient underwent an endovascular aortic repair on (b)(6)2012, in order to treat an aortic aneurysm associated to a right iliac aneurysm.Due to occlusion of the left limb of the aortic main body (non-gore device), the patient developed severe claudication in the left lower extremity.On (b)(6) 2013, a gore® propaten® vascular graft was used to perform a femoro-femoral cross over bypass to reestablish blood flow to the left lower extremity.On february 7, 2023, after about 9 years and 6 months years, the graft was explanted due to staphylococcus epidermidis infection.

Manufacturer Narrative

H3-other and h6-codes b01, b17, b15 and c21: the explanting physician sent the specimen to a 3rd party for evaluation.The 3rd party provided gore with a level 1 explant report which is being reviewed by gore explant scientists.H6-code b14: a review of the manufacturing records indicated that the lot met pre-released manufacturing specifications.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.

Manufacturer Narrative

Cause investigation and conclusion: a review of the manufacturing records, including sterilization records, indicated that the lot met pre-released manufacturing specifications.The physician has sent the explanted device to an independent 3rd party for evaluation.The 3rd party provided gore with their macroscopic analysis results of the explanted devices.The device enabling direct assessment of product performance was not returned to gore for evaluation.The 3rd party analysis results have been reviewed by gore explant scientists.The evaluation summary states the following: the abluminal surface was generally devoid of tissue, except for a foci of dark red/brown tissue near extremity b.A foci of dark red/brown tissue partially occupied the lumen at extremity b.The lumen was generally unobservable, and the luminal patency could not be determined with the information/images provided.Both extremities were cut.Extremity b was beveled and had blue monofilament running suture (presumptive anastomosis) along most of the extremity edge.No information was provided to confirm the presence or absence of the reported infection and no determination can be made from the provided information.The cause of the reported infection cannot be established based on the available information.Based on the incident description and the subsequent investigation, no further information was provided to gore, therefore we are unable to determine the cause of this incident and assign a root cause.No potential new or different reasonably foreseeable risks related to the device or its use were identified based on this event.Ongoing risk/benefit assessment affirms risk acceptability based on current performance.No corrective measures are needed as a result of this event.Gore will continue to monitor post-market data closely to ensure that the risk assessment remains accurate.In the instructions for use the following is stated: 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.

• 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: 16929757
• MDR Text Key: 315215237
• Report Number: 2017233-2023-03928
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): Y
• Reporter Country Code: FI
• 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: 09/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/29/2015
• Device Catalogue Number: IRTH084040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2011
• 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; Hospitalization
• Patient Age: 82 YR
• Patient Sex: Male