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

Model Number SRRT06070080L

Device Problems Microbial Contamination of Device (2303); Obstruction of Flow (2423)

Patient Problems Sepsis (2067); Obstruction/Occlusion (2422)

Event Date 05/26/2022

Event Type  Death  

Manufacturer Narrative

Patient identifier: no patient specific details have been provided.Therefore, the patient initials reflect the w.L.Gore internal case number.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).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.The medical device returned to a third party for further investigation.The analysis report was shared with gore and evaluated appropriately.Explant scientist observations: the graft fragment was reported to measure 402 mm in length with both ends transected.The majority of the abluminal surface was generally devoid of tissue with scattered dark red/brown and tan tissue present.A foci of tan/brown and yellow tissue was present on the abluminal surface in the mid-region of the fragment.A foci of tan/yellow and brown/red tissue was present on the abluminal surface near extremity b.The blue alignment marks were faintly visible (consistent with a stretch vascular graft).The lumen at both extremities of the fragment was occupied with dark red/brown tissue.The patency of the graft fragment could not be determined, based on the analysis or images provided.Rings were displaced around the mid-region of the fragment.In the region where the rings were displaced, the graft fragment is partially flattened.Rings were also not present near extremity b.Evenly spaced serration marks, consistent with forceps marks, were present at extremity b.Multiple blue, monofilament suture fragments were present at extremity b.Material disruptions (e.G., transections, forceps marks) were consistent with those caused by interaction with surgical instrumentation (e.G., scalpel/scissors, forceps/clamps), likely used during a surgical procedure.The exact time and cause of the displaced and absent rings can not be determined with the information provided.The graft was confirmed to have staphylococcus aureus present.The third party reported, ¿no previous history of infection¿, and ¿probably cutaneous contamination¿ regarding the potential source of the infection.Based on the information provided, the time and cause of the infection cannot be determined.The relation between the graft infection and patient death could not be determined with the information provided.In the instruction for use for the gore-tex® stretch vascular graft the following is stated: possible complications with the use of any vascular prosthesis complications which may occur in conjunction with the use of any vascular prosthesis include but are not limited to: infection; thrombosis.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 an occlusive peripheral arterial disease with a gore-tex® stretch vascular graft thin walled removable ringed.It was stated that the vascular graft was implanted on (b)(6) 2021, in the inferior genicular popliteal artery to treat a critical limb ischemia.On (b)(6) 2022, the device was explanted due to a septic thrombosis.The explanted vascular graft was replaced by a femoro-tibial bypass.Reportedly, the patient was frail and undergoing hemodialytic treatment and has no recorded medical history of pre-existing infection.The physician confirmed that the patient had septicemia, a hemoculture was conducted and staphylococcus aureus was identified as the causative micro-organism.Reportedly, the staphylococcus aureus was equally identified on the gore-tex® stretch vascular graft.In (b)(6) 2021 a tibial angioplasty was performed in order to improve the run-off and computed tomography angiography revealed an abscesses adjacent to the bypass.According to the additional information received from the physician, it is assumed that this could be the point of entry for the infection.On (b)(6) 2022, the patient deceased due to a septic shock.

• Brand Name: GORE-TEX® STRETCH 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: 16302523
• MDR Text Key: 308818197
• Report Number: 2017233-2023-03685
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00733132612413
• UDI-Public: 00733132612413
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K933943
• 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
• Report Date: 02/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2023
• Device Model Number: SRRT06070080L
• Device Catalogue Number: SRRT06070080L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/29/2018
• 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): Death
• Patient Age: 78 YR
• Patient Sex: Male