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

Device Problems Complete Blockage (1094); Migration (4003)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/02/2023

Event Type  Injury  

Event Description

The following literature was reviewed ¿u-bent viabahn stent graft in the main left pulmonary artery in a hemodialysis patient after asymptomatic migration: percutaneous removal and technical considerations¿ published by pietro quaretti , riccardo corti, antonio mauro d¿agostino and nicola cionfoli et al in the european journal of vascular access, volume 1-6, received 22 november 2022, accepted 02 february 2023, first published online 13 july 2023.The patient (50 years, male) presented with end-stage renal disease secondary to a neurogenic bladder and myelomeningocele.He started weekly hemodialysis through a left proximal radiocephalic fistula at the age of 45 years.Three years later, a radio-basilic prosthetic bridge (arteriovenous (av) graft not further specified) was anastomosed to the hypertrophied left proximal radial artery.40 days after the creation of the av graft it occluded.A 7 mm × 100 mm gore® viabahn® endoprosthesis with propaten bioactive surface (viabahn device) was implanted to treat critical venous stenosis at the elbow.361 days after the creation of the av graft a further thrombosis occurred.Edge stenosis on the first viabahn device was found to be recalcitrant to scoring and high-pressure angioplasty.A new 7 mm × 50 mm viabahn device (the second) was implanted to reestablish a brisk flow.498 days after the creation of the av graft a further thrombosis occurred.Critical edge stenosis in the last viabahn device following thrombolysis was reported.Due to unsuccessful pta result, a 6 mm × 50 mm viabahn device (the third) was overlapped distally for <1 cm with a 6 mm × 100 mm viabahn device (the fourth) to allow the coverage of further stenosis of the basilic vein.703 days after the creation of the av graft a further thrombosis occurred.Routine chest radiography on admission revealed a 100 mm long viabahn on the left side of the heart.Further imaging confirmed that the most distal 6 mm × 100 mm viabahn device has migrated to the main left pulmonary artery without signs of pulmonary infarction.The viabahn device appeared occluded and transversally bent in a u-configuration inside the trunk of the left pulmonary artery.The ends of the viabahn device were located near the pulmonary valve and floated inside the pulmonary artery.The patient denied any past thoracic discomfort and remained eupneic and asymptomatic.On unknown date the viabahn device was removed from the patient during an endovascular procedure through a single femoral access.The viabahn device was completely ensnared inside an introducer sheath and removed as a unit within the sheath without entanglement through the cardiac chambers.The patient was discharged two days later.

Manufacturer Narrative

The following literature was reviewed: ¿u-bent viabahn stent graft in the main left pulmonary artery in a hemodialysis patient after asymptomatic migration: percutaneous removal and technical considerations¿ published by pietro quaretti , riccardo corti, antonio mauro d¿agostino and nicola cionfoli et al in the european journal of vascular access, volume 1-6, received 22 november 2022, accepted 02 february 2023, first published online 13 july 2023.A2 - age: the age of the patient was estimated based on the days given within the literature.52 years was selected as a best estimate.B3 - date of event: the literature was accepted by the publisher on 02 february 2023.This date is used as the date of the incident as a best estimate.H6-b17 and h3 other: the location of the device is unknown.H6-b13: a request was emailed to the corresponding author to provide device information like serial numbers, and dates of the events and (re)interventions.The answer is pending.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

Cause investigation and conclusion requests were emailed to the corresponding author to provide device information like serial numbers, and dates of the events and (re)interventions.The requests remained unanswered.No information about the lot or serial number were provided, therefore, a product history record review could not be conducted.The reported migration of the endoprosthesis after deployment could not be independently confirmed during the investigation.Clinical images and a photograph in the literature are not sufficient to confirm device migration, nor to determine the root cause.In the literature, section "discussion", it is reported that "the coupling of stentgraft downsizing and inadequate stent overlap may have synergistically caused the present complication".Therefore the available information reasonably suggest that an unintended use error may have caused or contributed to the event.

• 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: sibylle staerk ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17442151
• MDR Text Key: 320213754
• Report Number: 2017233-2023-04164
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): Y
• Reporter Country Code: IT
• 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: 10/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/11/2023
• 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): Hospitalization; Required Intervention
• Patient Age: 52 YR
• Patient Sex: Male