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

Catalog Number PAHR081002E

Device Problems Off-Label Use (1494); Insufficient Information (3190)

Patient Problem Obstruction/Occlusion (2422)

Event Date 04/06/2021

Event Type  Injury  

Manufacturer Narrative

Patient information: the patient information was not provided.As the device remains implanted and the accessories were discarded on site, an evaluation of the device cannot be performed.(b)(4).A review of the manufacturing records indicated the lot met all pre-release manufacturing specifications.Ifu statement: in the ifu for the gore® viabahn® endoprosthesis with propaten bioactive surface the following was stated under the chapter warnings: the gore® viabahn® endoprosthesis with propaten bioactive surface is not indicated for use in the central circulatory system; such as, pulmonary arteries, aorta, coronary arteries, coronary bypass grafts, coronary sinus, carotid arteries, vertebral arteries, brachiocephalic (innominate) arteries, vena cavae or pulmonary veins.This event is considered as "off label-use".Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.

Event Description

It was reported to gore that patient underwent endovascular treatment for a pseudo carotid aneurysm with a gore® viabahn® endoprosthesis with propaten bioactive surface (viabahn-device).It was stated that the procedure went well and during the final run the graft was found patent.It was reported that the following morning the patient had a stroke score of 20.He was transferred to another hospital to interventional radiology department for thrombectomy.It was stated that the stroke score was reduced to 6.

Event Description

Updated description: it was reported to gore that patient underwent endovascular treatment for a pseudo carotid aneurysm with a gore® viabahn® endoprosthesis with propaten bioactive surface (viabahn-device).It was stated that the procedure went well and during the final run the graft was found patent.It was reported that the following morning the patient had a stroke score of 20.He was transferred to another hospital to interventional radiology department for thrombectomy.It was stated that the stroke score was reduced to 6.The distributor stated that he was advised that the viabahn-device occluded after the procedure.The patient was transferred to another hospital for a thrombectomy.This is all the information he was provided.

Manufacturer Narrative

H6 evaluation codes investigation findings 213 refers to phr-review.Product investigation conclusion: the specific cause of this complaint could not be determined.Gore did not receive the explanted device, and information regarding the device form was not available.A product history review was conducted for the viabahn-device in this complaint, and the review of the manufacturing records, including the manufacturing, heparin coatings, and sterilization processes, indicated the lot met pre-release manufacturing specifications.The investigation confirms the complaint of occlusion, but the cause cannot be confirmed.B5 describe event or problem was updated.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS WITH PROPATEN BIOACTIVE SURFACE
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 11840462
• MDR Text Key: 263365201
• Report Number: 2017233-2021-02014
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): Y
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 08/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/09/2023
• Device Catalogue Number: PAHR081002E
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention