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

Catalog Number H060040

Device Problem Microbial Contamination of Device (2303)

Patient Problem Bacterial Infection (1735)

Event Date 08/07/2020

Event Type  Injury  

Manufacturer Narrative

The study database entries of the physician have been reviewed.The explanted device was requested from the physician for evaluation.The answer is pending.A request was emailed to the physician to further clarify the event, like onset date of the infection, type of germs/bacteria, and cause of infection.The answer is pending.A review of the manufacturing records indicated the lot met all pre-release 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.

Event Description

On (b)(6) 2019, the patient underwent open surgery to implant a gore® propaten® vascular graft in the right arm for brachial-brachial hemodialysis access because of renal insufficiency.Patient history included hemodialysis through a right central venous catheter which was abandoned at the patient's request.On (b)(6) 2020, the first order to dialyze through the graft was made, which was successful.On (b)(6) 2020, the graft was explanted because of infection within and outside the graft and at the venous and the arterial anastomosis.The date of the infection remains unknown.

Manufacturer Narrative

Cause investigation and conclusion: a review of the manufacturing records indicated the lot met all pre-release specifications.Neither clinical images enabling direct assessment of product performance nor the product itself were returned for evaluation.Instead, the explanted graft was discarded at the facility.Additional information was provided by the physician, which is captured in the updated event description.Based on the updated event description there was no malfunction of the graft.Furthermore, there is no indication that the graft has caused or contributed to the infection.Instead, the physician stated that he assumes that the infection was caused by puncture of the graft for hemodialysis.This event no longer meets the criteria of a reportable incident and therefore is being closed out as a non-reportable incident.

Event Description

On (b)(6) 2019, the patient underwent open surgery to implant a gore® propaten® vascular graft in the right arm for brachial-brachial hemodialysis access because of renal insufficiency.Patient history included hemodialysis through a right central venous catheter which was abandoned at the patient's request.There was no history of pre-existing infection in the field of treatment.On (b)(6) 2020, the first order to dialyze through the graft was made, which was successful.On (b)(6) 2020, the patient was hospitalized for sepsis due to graft infection.The exact onset date of the infection remains unknown.The patient presented with fever and inflammatory signs in the graft.Ultrasound and computed tomography confirmed a periprosthetic abscess.Samples showed staphylococcus aureus.Then antibiotic treatment (initial piperacillin-tazobactam + vancomycin; subsequent cloxacillin and levofloxacin according to antibiogram) was started, and a temporary catheter for further hemodialysis was implanted.The physician stated that he assumes that the infection was caused by puncture of the graft for hemodialysis.On (b)(6) 2020, the patient underwent an open surgical ligation reintervention, and a partial resection of the graft was performed due to persistent sepsis.On (b)(6) 2020, positron emissions tomography confirmed persistence of infection of the graft.Therefore, the graft was explanted.In-situ situation showed infection within and outside the graft and at the venous and the arterial anastomosis.The physician reported that the patient recovered with no sequelae on the arm.

Manufacturer Narrative

Cause investigation and conclusion.A review of the manufacturing records indicated the lot met all pre-release specifications.Neither clinical images enabling direct assessment of product performance nor the product itself were returned for evaluation.Instead, the explanted graft was discarded at the facility.Additional information was provided by the physician, which is captured in the updated event description.Based on the updated event description there was no malfunction of the graft.Furthermore, there is no indication that the graft has caused or contributed to the infection.Instead, the physician stated that he assumes that the infection was caused by puncture of the graft for hemodialysis.In the instructions for use the following is stated: v.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.This event no longer meets the criteria of a reportable incident and therefore is being closed out as a non-reportable incident.

• 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: 15713380
• MDR Text Key: 302825871
• Report Number: 2017233-2022-03441
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): Y
• Reporter Country Code: SP
• PMA/PMN Number: K062161
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/13/2023

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 Expiration Date: 06/13/2023
• Device Catalogue Number: H060040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/22/2022
• Initial Date FDA Received: 11/02/2022
• Supplement Dates Manufacturer Received: 12/23/2022; 02/13/2023
• Supplement Dates FDA Received: 12/23/2022; 02/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2019
• 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: 77 YR
• Patient Sex: Male