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

Device Problems Contamination (1120); Microbial Contamination of Device (2303); Obstruction of Flow (2423); Appropriate Term/Code Not Available (3191)

Patient Problems Bacterial Infection (1735); Unspecified Infection (1930); Perforation of Vessels (2135); Obstruction/Occlusion (2422); Swelling/ Edema (4577)

Event Date 12/04/2021

Event Type  Injury  

Manufacturer Narrative

A1: no patient specific details have been provided.Therefore, the patient initials reflect the case number.A2 / a3: the patients age is 79 years and the gender male as stated in the article.B3: date of event was determined as date when literature article was published online, here december 4, 2021.H3 other code: as the device availability remains unknown, no further investigation can be performed.Product history review: a review of the manufacturing records for the devices could not be conducted because the serial/lot numbers remain unknown.Further details were requested from the corresponding author such as serial no's., implant date, date of event, patient id's, age, gender and weight, medical history of patient and possible root cause.Until now no further information was provided.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

The following literature article was reviewed: ¿acute infection of a viabahn stent graft inside a venous bypass ¿case report and review of the literature¿ published by nils lombilla et al.On december 4, 2021, in the annals of vascular surgery- brief reports and innovations, volume 2, issue 1, march 2022, 100032.A 79-year-old male patient was admitted to our outpatient clinic with edema of his right leg.He reported no pain, fever or claudication in this leg.His relevant prior medical history included hypertension and a venous femoropopliteal bypass (greater saphenous vein) performed 35 years earlier on the affected side due to fontaine iii claudication.Although being implanted for a considerable amount of time, the proximal anastomosis of the bypass had to be revised due to aneurysmal dilatation of the anastomosis 12 years ago.A part of the greater saphenous vein was used to perform an interposition autogenous graft.Three years ago, the bypass was revised again.This time the proximal part of the bypass appeared to be stenotic for which an endarterectomy with biological patch angioplasty closure was performed.During the same surgery the distal part of the venous bypass was treated successfully with two gore® viabahn® stents due to aneurysmatic dilatation.The patient recovered without any complications.Follow-up was done annually with us and revealed patency of the bypass without any aneurysmatic dilatation.Three years after the last operation the patient was admitted on our emergency ward.The vital signs of the patient were stable, whereas physical examination revealed a swollen right upper leg, without signs of infection (no redness, tenderness, fever or pain).Ultrasonography was directly obtained, which revealed a significant collection of fluid around the bypass graft, without any signs of flow as determined by dus.A cta was performed that showed no aneurysmal dilatations, but was suggestive for an infected bypass.Additional pet ct further supported this hypothesis.A two-pronged surgical treatment was proposed aimed at minimizing local bacterial load initially and time we needed to obtain a 100% biological prosthesis, whereas a second procedure was necessary to resect the infected stent graft and restore limb perfusion.Surgical exploration was performed on admission.After incising the old scars, significant amounts of pus and old blood were drained.Deep wound cultures were taken and antibiotic therapy using broadspectrum intravenous antibiotics was initiated.When inspecting the venous bypass graft, it became clear that one of the viabahn stent had perforated the graft and migrated outwards.An extensive debridement of the infective site was performed, thoroughly excising all suspicious tissue and lavating using 3l of water-iodine solution.A suction-drain was left in place and the wound was closed using absorbable sutures.Following this first procedure, the patient was monitored on the ward while continuing intravenous antibiotics consisted of a combination of amoxicillin and clavulanic acid, administered four times daily.We continued these antibiotics, since no fever was observed during this observation period, and the patient was improving clinically as well as biochemically.Seven days later we performed the second procedure, removing the greater part of the bypass.The viabahn endograft had completely eroded through the venous wall necessitating excision of all tissue that was in contact with the stent-grafts.The proximal and distal anastomosis were left in place since no signs of infection were seen upon inspection of the anastomoses.Furthermore, the distal part of the graft was firmly adhesive to surrounding tissue.A 100% biological prothesis (bio-integral, mac's medical group,leopoldsdorf bei wien, austria) was used to create an interposition bypass with an end-to-end proximal anastomosis connecting the proximal part, and an end-to-end anastomosis with the distal part of the venous bypass.

Manufacturer Narrative

H6 evaluation codes medical device problem code: a27: vsx device "eroded" through the venous bypass.The following literature article was reviewed: ¿acute infection of a viabahn stent graft inside a venous bypass ¿case report and review of the literature¿ published by nils lombilla et al.On december 4, 2021, in the annals of vascular surgery- brief reports and innovations, volume 2, issue 1, march 2022, 100032.Details like event date, serial no., implant- and explant date, patient details, possible root cause and if the device is available for investigation were requested several times, as well as details about the infection, but the author stated that he has no more information than the information that was presented in the article and that he cannot confirm nor deny any responsibility in this on the gore® viabahn® endoprosthesis with propaten bioactive surface (abbrev.: device).Reportedly, the device was implanted in the distal end of a venous bypass graft.The device allegedly perforated the venous graft and "migrated" outwards.However, available photos within the literature article of a singular time point could not confirm a "migration" event nor the identity of the device implanted.It is our understanding that the device remained in the intended position and "eroded" through the venous bypass most likely due to immune response in the patient to the infection.Neither clinical images enabling direct assessment of product performance, nor the device was returned for investigation.Moreover, review of the manufacturing records for the device could not be conducted because the serial/lot number remains unknown.Without a lot number or device serial number, the manufacturing date and/or production details cannot be determined, and the information provided to gore cannot be connected to a specific device.An assessment of appropriate device sizing was not possible with the available information, and no further details were provided to evaluate intraprocedural technical considerations, including appropriate overlap and post-dilation of the entire device length, that may influence adequate device apposition with a vessel wall or synthetic graft.The reported infection and occlusion of the device could not be independently confirmed based on available information.The root cause of the reported infection subsequently resulting in device "erosion" through the venous bypass, occlusion of the device, and subsequent surgical intervention to remove the device could not be established with the available information.

• 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: 18482142
• MDR Text Key: 332490402
• Report Number: 2017233-2024-04530
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): Y
• Reporter Country Code: NL
• 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: 03/26/2024

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: 12/18/2023
• Initial Date FDA Received: 01/10/2024
• Supplement Dates Manufacturer Received: 03/25/2024
• Supplement Dates FDA Received: 03/26/2024
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male