MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® VIABAHN® ENDOPROSTHESIS WITH PROPATEN BIOACTIVE SURFACE; SYSTEM, ENDO GRAFT, ARTERIOVENOUS DIALYSIS ACCESS CIRCUIT STENOSIS TREATMENT

Device Problem Migration (4003)

Patient Problem Stenosis (2263)

Event Date 07/17/2021

Event Type  malfunction  

Manufacturer Narrative

Literature article ¿stent migration: dangerous flight but safe landing¿ published by federico fontana et.Al in the journal of vascular and interventional radiology, volume 32, issue 10, october 2021, page 1515.No patient specific details have been provided.Therefore, the patient initials reflect the w.L.Gore internal case number.Patient age was 59 years and gender female as mentioned in the article.The date of incident is unknown.Therefore date of incident was determined as date when literature article was accepted, here july 17, 2021.Name: cbas® heparin surface, manufacturer/compounder: w.L.Gore & associates, inc., lot number: unk.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.

Event Description

Within the article â¿¿stent migration: dangerous flight but safe landingâ¿ published by federico fontana et.Al in the journal of vascular and interventional radiology, volume 32, issue 10, october 2021, page 1515, the following was indicated: a patient with a brachiocephalic fistula underwent balloon dilation of a stenosis to 5-mm diameter and subsequent 5-mm x 5-cm goreâ® viabahnâ® endoprosthesis with propaten bioactive surface placement.An attempt was made to postdilate the stent graft to 6 mm.Three months later, fistulography for recurrent dysfunction revealed disappearance of the stent graft.Fluoroscopy and contrast-enhanced computed tomography scan showed that the stent graft had migrated to a right lower lobe pulmonary artery branch and remained patent.The patient had no pulmonary symptoms; a multidisciplinary board elected to leave the stent in situ and to start anticoagulation.At the 1-year follow-up, the stent graft remained patent with no complications.The 5-mm stent graft was clearly undersized; however, the goreâ® viabahnâ® endoprostheses cannot be overexpanded.In retrospect, the placement of a second larger stent overlapping with the viabahn could have anchored the stent graft and prevented its migration.

Manufacturer Narrative

Product history review: a 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.The device remains implanted and was therefore not available for engineering evaluation.No images enabling direct assessment of performance were returned for evaluation.The reported information indicates a potential device malfunction, related to device migration, has occurred.The literature article indicates undersizing of the implanted gore® viabahn® endoprosthesis with propaten bioactive surface as contributing to the device migration event due to insufficient vessel wall apposition or anchoring of the device.Therefore, the cause of the reported malfunction is consistent with the user selecting an inappropriate diameter for the patient (i.E., diameter too small).An unintended use error caused or contributed to the event.In the instruction for use for the gore® viabahn® endoprosthesis with propaten bioactive surface the following is stated: in selecting the appropriate size endoprosthesis, a careful assessment of the vessel is necessary.In general, to assure adequate anchoring, the diameter of the endoprosthesis should be approximately 5 ¿ 20% larger than the healthy vessel diameter immediately proximal and distal to the lesion.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: malposition device related: complications and adverse events can occur when using any endovascular device.These complications include, but are not limited to: migration.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS WITH PROPATEN BIOACTIVE SURFACE
• Type of Device: SYSTEM, ENDO GRAFT, ARTERIOVENOUS DIALYSIS ACCESS CIRCUIT STENOSIS TREATMENT
• 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: 15239721
• MDR Text Key: 303339931
• Report Number: 2017233-2022-03221
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): Y
• Reporter Country Code: IT
• PMA/PMN Number: P130006
• 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: 11/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2022
• Is this an Adverse Event Report?: No
• 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: 11/08/2022
• 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
• Patient Age: 59 YR
• Patient Sex: Female