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

Catalog Number HT066080

Device Problem Microbial Contamination of Device (2303)

Patient Problems Wound Dehiscence (1154); Bacterial Infection (1735); Fever (1858); Inflammation (1932)

Event Date 12/05/2023

Event Type  Injury  

Event Description

It was reported to gore that the patient underwent surgical treatment for a critical limb ischemia with a gore® propaten® vascular graft ¿ thin-walled removable ringed.It was stated that the vascular graft was implanted on (b)(6) 2023, as a femoro-popliteal bypass to treat a critical limb ischemia.Since (b)(6) 2023, the patient has presented with fever, scar disunion, disunity of the scar, and the appearance of an inflammatory syndrome.The bypass scar was disunited with a serous ooze.On (b)(6) 2023, after about one month, the prosthesis was explanted due to a bacterial infection.The gore device was replaced with an allograft.The patient was discharged home on (b)(6) 2023, without any complications.Further information revealed that the infection is related to the implant procedure.

Manufacturer Narrative

A1: no patient specific details have been provided.Therefore, the patient initials reflect the w.L.Gore internal case number.H6 evaluation codes investigation findings c19 belongs to the product history review: a review of the manufacturing records indicated the lots met all pre-release specifications (manufacturing/packaging/boxing/sterilization).H6 evaluation codes type of investigation b13: additional information in regard to the event of the case was requested from the physician.The provided additional information is captured in the event description in section b5.H3: other code: the medical device returned to a third party for further investigation.The analysis report was shared with gore and is being evaluated appropriately.Further investigation is being conducted and will be included in the final report.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 the patient underwent surgical treatment for a critical limb ischemia with a gore® propaten® vascular graft ¿ thin-walled removable ringed.It was stated that a vascular graft (sn (b)(6)) was implanted on (b)(6) 2023, as a femoro-popliteal bypass to treat a critical limb ischemia.Later the proximal anastomosis obliterated, therefore, on (b)(6) 2023, a further gore® propaten® vascular graft ((b)(6)) was implanted.During this procedure bacteria have been introduced and wound dehiscence due to infection was diagnosed (b)(6) 2023.The patient has presented with fever, dehiscence of the bypass scar with a serous secretion and inflammatory syndrome, requiring hospitalization.Imaging confirmed infection of the grafts.Samples taken were positive to staphylococcus epidermis, corynebacterium tuberculostearicum and staphylococcus aureus.The anastomoses were stenosed and the graft was thrombosed due to persistent infection.Therefore, on (b)(6) 2023, both devices were explanted and were replaced with an allograft.The patient recovered without sequelae and was discharged home on (b)(6) 2023.There was no preexisting infection and the physician stated that the infection was related to the implant procedure of propaten ((b)(6)).

Manufacturer Narrative

B5 describe event or problem updated.

Manufacturer Narrative

Explant evaluation: the graft fragment was returned to gepromed for investigation.Submitted in formalin was a gore® propaten® vascular graft ¿ thin-walled removable ringed fragment.The scope and results of the investigation were summarized, and a report was submitted to w.L.Gore & associates.An explant scientist at w.L.Gore & associates reviewed the report.The graft fragment was reported to measure 295 mm in length, and both ends appeared to have been transected.The abluminal surface had focal areas of light yellow to red biologic material present, and the blue alignment marks were faintly visible.The rings appeared to be displaced at the mid-body and near extremity b of the fragment.The lumen at extremity b of the fragment appeared to be open.Extremity a appeared to be flattened with evenly spaced serration marks present, and removable rings were absent in this area.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, serrations) were consistent with those caused by surgical instrumentation (e.G., scalpel, scissors, hemostats), which likely occurred during a surgical procedure.Based on the explant scientist¿s review of the gepromed report, no additional analysis is requested.No information was provided to confirm the presence or absence of the reported infection and no determination can be made from the provided information.In the instruction for use for the gore® propaten® vascular graft the following is stated: adverse events: potential device or procedure-related adverse events: complications which may occur in conjunction with the use of any vascular prosthesis and/or vascular or related procedures 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: gunter marte ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18569465
• MDR Text Key: 333549129
• Report Number: 2017233-2024-04560
• 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,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: HT066080
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2023
• 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: 69 YR
• Patient Sex: Male