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

Catalog Number JHHR101002J

Device Problems Device Handling Problem (3265); Migration (4003)

Patient Problem Perforation of Vessels (2135)

Event Date 04/14/2023

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing records indicated the lots met all pre-release specifications.The device remains in the patient.Consequently, a direct product analysis was not possible.According to the gore® viabahn® endoprosthesis with heparin bioactive surface instructions for use: warnings: special care should be taken to ensure that the appropriate size endoprosthesis, compatible sheath and guidewire are selected prior to introduction.Native vessel dimensions must be accurately measured, not estimated.Failure to follow the appropriate device sizing recommendations or failure to ensure proper device placement, including overlap conditions, prior to deployment can result in ischemic conditions, vessel damage/rupture, and related serious harms, potentially necessitating surgical intervention.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

The following information was reported to nihon-gore japan: on (b)(6) 2023, this patient underwent a reintervention for a previously implanted non-gore device (zenith alpha thoracic endovascular graft, cook medical) using gore® tag® conformable thoracic stent graft with active control system (hereinafter ctag), gore® dryseal flex introducer sheath (hereinafter sheath) and gore® viabahn® endoprosthesis (hereinafter viabahn).The physician planned to deliver devices from left side, however, the heavily calcified left external iliac artery (hereinafter leia) was making the access challenging.Pre-measurement by physician indicated that the diameter of the leia was 6 mm, and the computed tomography showed the narrowest part being only 4 mm.The physician inserted the sheath from left femoral artery which ceased to advance through leia as expected.For securing the access route, a gore® viabahn® endoprosthesis (hereinafter viabahn) was used to fashion an endo-conduit on leia.While advancing the sheath second time, the distal portion of viabahn moved to its proximal side and traumatized the leia.Since the leading tip of the sheath was inside viabahn for about 2 cm, the physician decided to continue delivering the ctag above leia without the sheath.The ctag was successfully implanted.At the end of the procedure, an echo-doppler exam indicated the decreased blood pressure on patients¿ left leg.A fem-pop bypass was performed using gore® propaten® vascular graft for the treatment.The patient tolerated the procedure.Reportedly, the viabahn (jhhr101002j) used for an endo-conduit was excessively over-sized for 4-6 mm leia but it was an inevitable choice to accommodate 20 fr sheath for ctag implantation.The fsa suggested that the over-sized viabahn could have caused poor sealing against the vessel wall, and thus injured the leia during its migration.The reporting physician commented: it was concerned preoperatively that any device would cause a trauma on access vessel as the patient had injured right femoral artery during the use of non-gore device at the time of initial procedure.

Manufacturer Narrative

Corrected h6: investigation conclusions to d1103.The reasonably foreseeable misuse of the vsx device, selecting a device having diameter that is too large for the vessel, was reported with the complaint.This 10mm diameter vsx device was purposefully chosen to serve as a conduit to facilitate the sheath for delivery of a gore® tag® conformable thoracic stent graft with active control system (ctag), and this vsx device is over-sized for the 4-6mm diameter vessel.The implanted, over-sized vsx device interacted with the sheath during subsequent delivery of the ctag device, and the vsx device endoprosthesis compressed longitudinally as a result.The vsx device interacted with the vessel wall as it was compressed leading to the reported perforation.The cause for the vessel perforation is related to selection of a device that was too large for the vessel.According to the gore® viabahn® endoprosthesis with heparin bioactive surface instructions for use: warnings: special care should be taken to ensure that the appropriate size endoprosthesis, compatible sheath and guidewire are selected prior to introduction.Native vessel dimensions must be accurately measured, not estimated.Failure to follow the appropriate device sizing recommendations or failure to ensure proper device placement, including overlap conditions, prior to deployment can result in ischemic conditions, vessel damage/rupture, and related serious harms, potentially necessitating surgical intervention.Measure the vessel or prosthetic graft diameter carefully and select the appropriate stent graft size.To assure adequate anchoring, the stent graft size of approximately 5¿20% larger than the healthy vessel diameter immediately proximal and distal to the lesion should be selected (table 1).

• 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: amy mckeown ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 16896182
• MDR Text Key: 314851312
• Report Number: 2017233-2023-03916
• 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: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: JHHR101002J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2023
• 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 Outcome(s): Other
• Patient Age: 71 YR
• Patient Sex: Female