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

Catalog Number JHJR061002J

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pseudoaneurysm (2605)

Event Date 04/21/2023

Event Type  Injury  

Manufacturer Narrative

C1: cbas® heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.H3: code "other" was selected as the medical device remains implanted.Return not possible.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

On an unknown date in (b)(6) 2022, the patient underwent an endovascular treatment for a peripheral arterial disease using gore® viabahn® endoprosthesis with heparin bioactive surface (vsx) and an eluvia¿ drug-eluting vascular stent system from boston scientific (eluvia).The vsx and the eluvia were implanted as a combined unit at an occlusive lesion of right superficial femoral artery.On (b)(6) 2023, a type endoleak from the joint of implanted vsx and eluvia, and formation of pseudoaneurysm were observed.On (b)(6) 2023, reintervention was performed for implanting an additional vsx to line the joint part of previously implanted vsx and eluvia.A terumo 7fr glidesheath slender® was inserted by the ipsilateral anterograde approach and a cordis 0.018 vassallo® gt floppy was used as a guide wire for delivering the vsx.When the physician positioned the vsx to the intended site and pulled the deployment knob, a strong resistance was felt.The physician tried to pull the deployment knob with force, however, it failed to initiate the deployment.The vsx was removed and replaced by another vsx of the same size.The procedure was completed without further reported issues.According to the physician, a ¿bow string¿ was seen as he attempted to initiate the deployment.He also stated that he had intentionally avoided pre-ballooning in order to not complicate the type endoleak and pseudoaneurysm.He suspects that the vsx could have been caught on eluvia¿s metal frame while being delivered in the narrow lumen.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
• Type of Device: SYSTEM, ENDO GRAFARTERIOVENOUS 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: samir kulovic ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 16968673
• MDR Text Key: 315642860
• Report Number: 2017233-2023-03941
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: P130006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: JHJR061002J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/22/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/07/2022
• 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