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

Catalog Number VBHR131002A

Device Problems Accessory Incompatible (1004); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Vascular Dissection (3160); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/19/2023

Event Type  Injury  

Event Description

The following information was reported to gore: on (b)(6) 2023, the patient presented with high grade common femoral artery stenosis where the physician was only going to treat it with a percutaneous transluminal angioplasty (pta).However, when ballooning the stenosis at the anastomosis of a previously placed surgical bypass graft, it resulted in a dissection, causing the patient to become unstable.The physician decided to use a 13mmx10cm gore® viabahn® endoprosthesis with heparin bioactive surface (viabahn device) to repair the dissection.The physician exchanged the 10fr to a 12fr cook sheath.The procedure was successfully completed with a gore® viabahn® endoprosthesis with heparin bioactive surface.The patient was stabilized.A few hours after the initial procedure, there was an access site complication with internal bleeding.The bleeding was unable to be resolved in the interventional radiology lab, the patient was taken to the operating room for a surgical repair that was unsuccessful.The patient expired.

Manufacturer Narrative

H6: c21, pending product history review and engineering evaluation.Cbas® heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.As gore was unable to determine which device/device component is involved in this reportable adverse event, the following additional device will be identified in this report: gore® viabahn® endoprosthesis with heparin bioactive surface.Lot#: 25179950.Catalog#: vbhr131002a.Udi#: (b)(4).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

Gore was unable to confirm with user facility which device/device component was involved in the reportable adverse event.One gore® viabahn® endoprosthesis with heparin bioactive surface (device) was unable to go through sheath is not considered reportable by gore as the constrained device was removed with no issues and no harm to patient.The second device information is: lot/serial number: (b)(6); catalog number: vbhr131002a; udi number: (b)(4).H6 - code c19: review of device manufacturing record history confirmed both devices met pre-release specifications.H6 - code b20: the deployed device remains implanted.Therefore, direct product analysis was not possible.H6 - code g07001: device deployed as intended (no device related issues reported).H6 - investigation conclusion: cause traced to another device.There were no reported issues with the gore device.Applicable ifus for gore® viabahn® endoprosthesis with heparin bioactive surface that was unable to go through sheath: note: if excessive resistance is felt as the gore® viabahn® endoprosthesis with heparin bioactive surface is introduced through the hemostasis valve, remove and inspect the delivery system for damage.Do not reuse the gore® viabahn® endoprosthesis with heparin bioactive surface if damaged.Ensure a compatible introducer sheath size (table 1a and table 1b), and that the introducer sheath is free of kinks.The 13 mm diameter device is not compatible with the 10 fr cook® flexor® check-flo® introducer.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.Special care should be taken to ensure that compatible introducer sheath(s) and guidewire(s) are selected prior to endoprosthesis introduction.Failure to do so may result in damage to the endoprosthesis, endoprosthesis dislodgement from the delivery system, endoprosthesis bowstringing, partial or inaccurate deployment, vessel damage, and/or ischemic complications, potentially requiring surgical intervention.A4 - patient weight was requested but not made available.B5 - event description was updated with additional details obtained from physician and user facility.B7 was updated with known patient information.Additional patient history and/or medications was requested, but not provided.G2 was updated.Correction codes in h6: codes e2402, f1901 and g07 - the gore® viabahn® endoprosthesis with heparin bioactive surface was advanced and deployed at the intended treatment site with no issues.It was reported the issue was access site complication that led to bleeding.

Event Description

The following information was reported to gore: on (b)(6), 2023, a patient presented with in-stent restenosis from the common femoral artery to external iliac artery.As reported, this patient had been deemed unsuitable for surgical intervention.Consequently, the physician reportedly elected to treat the stenotic lesion with percutaneous transluminal angioplasty (pta).An 8mm balloon (brand unknown) was first used through a 6fr sheath (brand unknown).The balloon was then switched to a 10mm balloon.While using the 10mm balloon, the external iliac artery reportedly ruptured.To treat the rupture, a 13mm x 10cm gore® viabahn® endoprosthesis with heparin bioactive surface (viabahn device) was selected.The 6fr introducer sheath was switched out to a 10fr cook® flexor® check-flo® sheath with a touhy valve (possibly 45 cm length).Reportedly, due to the urgent situation, the viabahn device carton label and ifu indicating incapability with 10 cook® flexor® check-flo® sheath was missed by the hospital staff.The viabahn device reportedly became stuck as it was unable to fit through the sheath.The constrained viabahn device was withdrawn, and the sheath was exchanged from the 10fr to a 12fr cook sheath.A second viabahn device of the same size was implanted successfully.The patient's condition was stabilized, and the procedure was ended.To close the access site, the physician stated he ¿did a double perclose¿ (using abbott perclosetm).It was reported to gore that later the same day, it was realized the patient had a ¿perclose injury¿ leading to internal bleeding.It was reported by hospital staff that after the initial procedure, the patient complained of ongoing pain for a few hours and the patient became unstable due to the blood loss., the patient was reportedly transferred to the operating room (or) for a surgical intervention where access site complication with internal bleeding was said to be observed.The physician stated the blood loss was concerning and the hospital surgeons tried to do a fem fem bypass to stop the bleeding.However, the physician reported that the femoral artery of the contralateral groin that had not accessed had ¿deteriorated¿.The patient expired in the or.

• 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: genevieve begay ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17628338
• MDR Text Key: 322020507
• Report Number: 2017233-2023-04231
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 00733132646142
• UDI-Public: 00733132646142
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: VBHR131002A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2022
• 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): Hospitalization; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male