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

Catalog Number JHJR080502J

Device Problem Migration (4003)

Patient Problem Insufficient Information (4580)

Event Date 06/15/2023

Event Type  malfunction  

Manufacturer Narrative

H6 b20: the device remains implanted and was therefore not available for engineering evaluation.H6 c20: 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.Cbas® heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.Cause of the reported event cannot be established based on evaluation of the information reported to gore.Further information regarding this event was requested by gore, but no further information has been reported, therefore this investigation is considered complete.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 publication was reviewed: title: extravascular migration of a stentgraft into the bladder: a rare complication after endovascular treatment of an arterio-ureteral fistula source: vascular and endovascular surgery 2024, vol.58(1) 90¿94. the patient underwent urgent placement of an 8-mm×50-mm gore viabahn stent graft in the left eia.The device was chosen from among available off-the-shelf products and it was oversized by 20% compared with the diameter of the eia.Both the proximal and distal landing zone lengths were approximately 20 mm.Her hematuria resolved after the procedure.The patient was also suspected of having an entero-vesical fistula because the presence of intravesical air was observed on ct.However, other investigations did not confirm its presence.At 2 months after the procedure, the patient presented with fever and fatigue.The laboratory findings at this point showed a hemoglobin level of 9.7 g/dl, a wbc count of 14310/ l, and a crp level of 13.17 mg/dl.Ct suggested a colovesical fistula and also showed diffuse stenosis of the left eia.Ct performed 1 month later showed occlusion of the left eia and migration of the distal part of the stentgraft into the bladder.The patient remained free from recurrent hematuria and did not exhibit lifestyle-limiting symptoms of limb ischemia.Considering her poor nutritional status and frailty, intervention for stentgraft migration was not performed.The patient died 6 months later from complications of complex entero-vesical fistula.An autopsy was not performed.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN 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: vanessa rodriguez ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18471360
• MDR Text Key: 332905963
• Report Number: 2017233-2024-04525
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: JHJR080502J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2023
• 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