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

Model Number S0607

Device Problem Microbial Contamination of Device (2303)

Patient Problem Bacterial Infection (1735)

Event Date 02/25/2022

Event Type  Injury  

Event Description

The patient presented with a critical ischemia because of stenosis (80 %) of the left internal carotid artery due to chronic atherosclerotic arterial disease.Reportedly, the patient had no history of systemic infection or preexisting infection in the treatment area.On (b)(6) 2021, a gore-tex® stretch vascular graft was implanted as a carotido-carotid bypass from the right side to the left side to treat the critical ischemia.The anastomoses were at the right carotid bifurcation and at the left internal carotid artery distally of the lesion.On (b)(6) 2022, the graft was explanted due to an infection.It remains unknown when the infection was first identified and which bacteria contributed to the infection.It remains also unknown what further treatments were performed to resolve the infection.Reportedly, the physician did not provide any information as to why the graft became infected.It was reported that the physician has no suspicion that the gore graft or the procedure contributed to the infection.

Manufacturer Narrative

Patient id: the patient id could not be obtained.Therefore the analysis report number provided by the third party was used was the patient id.(b)(4).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 indicated the lots met all pre-release specifications.The physician sent the explanted device to an independent 3rd party for evaluation.Investigation (macroscopic and microscopic analysis of the explanted vascular graft after cleaning) was performed by the third party.The device was not returned to gore for evaluation.Instead, they provided analysis results to gore, which were reviewed by gore explant scientists.The explant evaluation summary states the following: the specimen was reported to measure 30 mm in length with both ends transected.The graft fragment was encased in varying degrees of thickness of tan to dark red brown tissue and the blue alignment marks were not visible.The lumen at extremity a appears partially occupied with light tan to dark red/brown tissue and extremity b lined with a thin layer of light tan tissue.The patency of the graft fragment could not be clearly determined based on the analysis or images provided.Material disruptions (e.G., transections) were consistent with those caused by surgical instrumentation (e.G., scalpel, scissors) during the explant process.Based on the explant scientist¿s review of the geprovas report, no additional analysis is requested.The origin of infection cannot be determined with the information provided nor via the analyses available.Reportedly, the physician did not provide any information as to why the graft became infected and what bacteria contributed to the infection.It was reported that the physician has no suspicion that the gore graft or the procedure contributed to the infection.Based on the event description and the subsequent investigation we are unable to determine the cause of this incident and assign a root cause.The instructions for use state the following: 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;.

Manufacturer Narrative

H3-other, and h6-codes b15 and c19 the explanted device was not returned to gore for evaluation.The explanting physician sent the explanted device to an independent 3rd party for evaluation.Investigation (macroscopic and microscopic analysis of the explanted vascular graft) was performed by the third party.They provided analysis results to gore, which have been reviewed by gore explant scientist.The summary of observations states the following: the specimen was reported to measure 30 mm in length with both ends transected.The graft fragment was encased in varying degrees of thickness of tan to dark red brown tissue and the blue alignment marks were not visible.The lumen at extremity a appears partially occupied with light tan to dark red/brown tissue and extremity b lined with a thin layer of light tan tissue.The patency of the graft fragment could not be clearly determined based on the analysis or images provided.Material disruptions (e.G., transections) were consistent with those caused by surgical instrumentation (e.G., scalpel, scissors) during the explant process.Based on the review of the 3rd party report, the origin of infection cannot be determined with the information provided nor via the analyses available.

• 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: sibylle staerk ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15525966
• MDR Text Key: 301011920
• Report Number: 2017233-2022-03370
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00733132611317
• UDI-Public: 00733132611317
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K903931
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: S0607
• Device Catalogue Number: S0607
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/09/2020
• 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: 54 YR
• Patient Sex: Male