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

Catalog Number HT060080

Device Problem Microbial Contamination of Device (2303)

Patient Problems Bacterial Infection (1735); Fistula (1862); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/29/2023

Event Type  Injury  

Event Description

According to reports (b)(6) 2022, this patient underwent surgical treatment for a critical limb threatening ischemia with trophic disorders in the common femoral artery in which a gore® acuseal vascular graft was implanted.Reportedly, on (b)(6) 2023, after about one year, the prosthesis was explanted due to an infection.

Manufacturer Narrative

A1: no patient specific details have been provided.Therefore, the patient initials reflect the w.L.Gore internal case number.H3 other code: the medical device returned to a third party for investigation.The analysis report will be shared with gore and will be evaluated appropriately.H6 b14: a review of the manufacturing and sterilization records could not be performed because the serial number is unknown.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

A1: no patient specific details have been provided.Therefore, the patient initials reflect the w.L.Gore internal case number.Emdr section h6 codes updated to reflect results of investigation.Emdr section h6: code d12-the instructions for use (ifu) for the appropriate region and time-period was reviewed with respect to the complaint detail.The ifu states the following: complications which may occur in conjunction with the use of any vascular prosthesis include but are not limited to infection.

Manufacturer Narrative

B5: description of event updated.D1, d2a, d2b updated.D4 updated.D6a, d6b updated.G4 updated.Emdr section h6 codes updated to reflect results of investigation.

Event Description

According to reports (b)(6) 2022, this patient underwent surgical treatment for a critical limb threatening ischemia with trophic disorders in the common femoral artery in which a gore® propaten® vascular graft was implanted.In (b)(6) 2022 the patient underwent a right transfemoral amputation in (b)(6) 2022.Reportedly the gore prosthesis was ligated at the time.Reportedly on (b)(6) 2023, during a consultation, a small fistula was present on the right amputation stump.Antibiotic therapy was started.During the operation, on (b)(6) 2023, samples were taken and found to be positive for c.Striatum, the prosthesis was explanted due to the infection.The device was not returned to gore directly but our third party vendor for an evaluation which showed the following results: no information was provided to confirm the presence or absence of the reported infection and no determination can be made from the provided information.Based on the explant scientist¿s review of the gepromed report, no additional analysis is requested.

• 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: samir kulovic ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17735260
• MDR Text Key: 323252203
• Report Number: 2017233-2023-04270
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/29/2022
• Device Catalogue Number: HT060080
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/16/2023
• 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): Other
• Patient Age: 75 YR
• Patient Sex: Male