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

Catalog Number SRRT06060080L

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

Patient Problems Bacterial Infection (1735); Post Operative Wound Infection (2446); Thrombosis/Thrombus (4440)

Event Date 12/29/2015

Event Type  Injury  

Event Description

Gore received an adverse event alert from a retrospective vascular graft study.On (b)(6) 2015, the patient presented with an occlusion in the right leg due to peripheral artery disease (pad, fontaine scale iv - ulceration or gangrene) and underwent surgical treatment for an femoro-popliteal bypass using a gore-tex® vascular graft.Heparin was used during the procedure.The graft was successfully implanted and no adverse events were reported during the procedure.Adjunctive procedures were not performed.On (b)(6)2015, the patient presented with an infection of the graft.Reportedly the infection was related to the initial procedure.On (b)(6)2015, the graft was explanted.Reportedly, on (b)(6) 2016, the infection was finally resolved without sequelae.

Manufacturer Narrative

H6-b15: gore received an adverse event alert from study database.The ecfr was reviewed and the provided information is captured in sections a through e.H6-b14: a review of the manufacturing records indicated the lots met all pre-release specifications.H6-b17 and h3 other: the location of the device remains unknown.Therefore a device evaluation could not be performed.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

Gore received an adverse event alert from a retrospective vascular graft study.It was reported that, on (b)(6) 2015, the patient presented with an occlusion in the right leg due to peripheral artery disease (pad, fontaine scale iv - ulceration or gangrene) and underwent surgical treatment with a gore-tex® vascular graft used as a femoro-popliteal bypass.Reportedly there was no pre-existing infection in the field of treatment.Heparin was used during the procedure.The graft was successfully implanted.On (b)(6) 2015, the patient presented with dehiscence of the incision scar at the access site without the graft being externally exposed.Reportedly the cause for dehiscence was infection of the incision site because of chronic sepsis of an abdominal plaque and undernourishment.The infection of the incision site was reportedly related to the procedure.The infection has spread and led to graft infection and septic thrombosis of the graft secondary to graft infection.It was reported that bacteriological testing confirmed bacterial infection of the graft.On (b)(6) 2015, the graft was explanted due to infection and thrombosis.The patient was treated with antibiotics for 3 weeks.Reportedly, on (b)(6) 2016, the infection finally resolved without sequelae.

Manufacturer Narrative

The incident information was received from a prospective/retrospective study.The database entries were reviewed and a request was sent to the study coordinator to further clarify the event.The provided information was captured in section b5.

Manufacturer Narrative

B3: updated event description.Cause investigation and conclusion.The incident information was received from a prospective/retrospective study.The database entries were reviewed and a request was sent to the study coordinator to further clarify the event.The provided information was captured in section b.A review of the manufacturing records indicated the lots met all pre-release specifications.Neither images enabling direct assessment of product performance nor the product itself, the location of which is unknown, were returned for evaluation.The reported infection could not be independently confirmed during the investigation.Based on the incident description and the subsequent investigation, no further information was provided to gore, we are unable to determine the cause of this incident and assign a root cause.The patient presented with systemic bacterial infection and graft infection that reportedly was attributable to the implant procedure because of no pre-existing infection.The available information reported in the complaint does not reasonably suggest that the graft has caused the infection.The reported device infection represents a known complication or adverse event that can occur when using vascular prosthesis and can arise as a result of a multitude of factors, including intraprocedural technical considerations, post-operative follow-up and treatment regimen and patient-related risk factors.No allegation of device malfunction was indicated with respect to device performance.The gore-tex® stretch vascular graft instructions for use (ifu), for the appropriate region and time-period, was reviewed with respect to the complaint detail and there are applicable statements.The ifu states the following: 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.

Event Description

Gore received an adverse event alert from a retrospective vascular graft study.It was reported that, on (b)(6) 2015, the patient presented with an occlusion in the right leg due to peripheral artery disease (pad, fontaine scale iv - ulceration or gangrene) and underwent surgical treatment with a gore-tex® vascular graft used as a femoro-popliteal bypass.Heparin was used during the procedure.The graft was successfully implanted.On (b)(6) 2015, the patient presented with an infection of the graft.Reportedly the surgical incision has re-opened.Bacteriological testing confirmed systemic bacterial infection.It was reported that the infection is be related to the initial procedure as there was no pre-existing infection.On (b)(6) 2015, the graft was explanted due to the infection.Reportedly, on (b)(6) 2016, the infection finally resolved without sequelae.

• 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: 17499226
• MDR Text Key: 321152132
• Report Number: 2017233-2023-04192
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00733132612383
• UDI-Public: 00733132612383
• 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,Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/08/2020
• Device Catalogue Number: SRRT06060080L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2015
• 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: 91 YR
• Patient Sex: Female