MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® VIABAHN® ENDOPROSTHESIS WITH PROPATEN BIOACTIVE SURFACE; STENT, SUPERFICIAL FEMORAL ARTERY

Device Problem Contamination (1120)

Patient Problems Ischemia (1942); Post Operative Wound Infection (2446)

Event Date 11/19/2021

Event Type  Injury  

Event Description

Within the article ¿the great stent graft escape¿ published by caitlin s.Macleod et.Al in the european journal of vascular and endovascular surgery, volume 62, issue 5, november 2021, page 737, the following was indicated: a patient presented with a six week history of two purulent wounds on the medial aspect of his right transfemoral amputation stump (performed in 2015), and a chronic sinus distally.A computed tomography scan showed a kinked right superficial femoral artery (arrow) with an uncovered stent and a gore® viabahn® endoprosthesis inserted in 2015 for chronic limb threatening ischaemia and dissection during angioplasty.Despite initial conservative antibiotic management, the wounds deteriorated so the endoprostheses were explanted.Staphylococcus aureus was cultured and a two-week course of intravenous flucloxacillin was given.

Manufacturer Narrative

Literature article ¿the great stent graft escape¿ published by caitlin s.Macleod et.Al in the european journal of vascular and endovascular surgery, volume 62, issue 5, november 2021, page 737.No patient specific details have been provided.Therefore, the patient initials reflect the w.L.Gore internal case number.Patient age was 72 years and gender male as mentioned in the article.The date of incident is unknown.Therefore date of incident was determined as date when literature article was published, here november 19, 2021.Name: cbas® heparin surface.Manufacturer/compounder: w.L.Gore & associates, inc.Lot number: unk.As the status of the device is unknown, no investigation of the device can be performed.For further evaluation the author was asked, if more details such as serial-no., implant date, date of event, patient id and weight and possible root cause are available.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.

Manufacturer Narrative

Multiple attempts were made to obtain additional information from the author, like patient information, serial number, date of procedure, onset date of infection, date of reintervention, imaging series, if the infection is attributable to our gore device, if there was a pre-existing infection etc.The requests remained unanswered.The serial number remains unknown, therefore a review of the manufacturing records could not be performed.Neither images enabling direct assessment of product performance nor the product itself were returned for evaluation.With no additional information provided, gore is unable to perform further investigations of this complaint and the cause of the reported event could not be established.In the instruction for use for the gore® viabahn® endoprosthesis with propaten bioactive surface the following is stated: hazards and adverse events procedure related: as with all procedures that utilize techniques for introducing a catheter into a vessel, complications may be expected.These complications include, but are not limited to: access site infection device related: complications and adverse events can occur when using any endovascular device.These complications include, but are not limited to: infection.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS WITH PROPATEN BIOACTIVE SURFACE
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: gunter marte ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15247171
• MDR Text Key: 298115362
• Report Number: 2017233-2022-03231
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): Y
• Reporter Country Code: UK
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/27/2022

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 Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/25/2022
• Initial Date FDA Received: 08/18/2022
• Supplement Dates Manufacturer Received: 10/07/2022
• Supplement Dates FDA Received: 10/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: UNCOVERED STENT
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male