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

Catalog Number PAJR050202E

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 07/16/2020

Event Type  Injury  

Manufacturer Narrative

As the device remains implanted, a further investigation on the device cannot be performed.The author was contacted to ask for further details like event date, serial no., implant date as well as possible root cause.Date of event was determined as date when literature article was published, here (b)(6) 2020.As patient age (b)(6) was determined and as gender female as mentioned in the article.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

The following literature was reviewed: preliminary experience using a covered stent graft in patients with acute ischemic stroke and carotid tandem lesion" published by carlos pinana et al.In cardiovascular & interventional radiology 2020;43(11):1679-1686.The study reviews the use of a covered stent graft (gore¿ viabahn¿ endoprosthesis with propaten bioactive surface) for patients with acute ischemic stroke (ais) and tandem lesions in a high-volume comprehensive stroke center in a real-life scenario.A retrospective review of all patients that underwent carotid endovascular interventions during mechanical thrombectomy for ais using a self-expanding covered stent graft at vall dhebron university hospital between 2016 and 2018 was conducted.Patient clinical and angiographical characteristics as well as postoperative outcome and follow-up were recorded.A total of eight patients were treated with the covered stents.As post-procedural complications a high level of occlusion at three-month follow-up was found.The stents of five patients (patient 2, 3, 4, 5 and 6) were occluded, although the patients did not show signs of stroke recurrence.This case represents patient 2.

Manufacturer Narrative

The author came back and stated the following comment: this is a case of a patient with bad aspects and sub-optimum reperfusion tici score, but very young therefore stenting was decided with the aim of improving global circulation and collateral flow to persue the best clinical outcome possible.Nevertheless the antiplatelet strategy was not aggressive during the procedure considering high risk of bleeding, but initiated immediately after, and switched to dual therapy after safe control ct.Unfortunately this approach proved to be insufficient to keep the stent patent.A review of the manufacturing-, sterilization- and heparin coating records will be performed.

Manufacturer Narrative

H6.Evaluation codes investigation findings 213 refers to the product history review: a review of the manufacturing records indicated the lot met all pre-release manufacturing specifications.The device remains implanted in the patient, therefore a device evaluation could not be performed.The information reported in the complaint, including reference patient clinical information, does not reasonably suggest a potential malfunction has occurred.Neither clinical images enabling direct assessment of product performance nor the product itself were returned for evaluation.With the information reported to gore this investigation is considered complete, the cause of the complaint was unable to be determined,.

• 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
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: gunter marte ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12317313
• MDR Text Key: 266367458
• Report Number: 2017233-2021-02243
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): Y
• Reporter Country Code: SP
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/19/2020
• Device Catalogue Number: PAJR050202E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 38 YR
• Patient Sex: Female