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

Catalog Number PAH111002E

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

Patient Problem Thrombosis/Thrombus (4440)

Event Date 08/03/2018

Event Type  Injury  

Manufacturer Narrative

As the device remains implanted, an investigation on the device cannot be performed.Date of event was determined as date when literature article was accepted, here (b)(6) 2020.As patient age (b)(6) was determined and as gender male 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 article was reviewed: ¿ antegrade common femoral artery access site closure using the manta vascular closure device¿ published by wouter stomp in the radiology case reports volume 15, issue 11, november 2020, pages 2205-2207.In antegrade peripheral endovascular procedures, the use of covered stents may require a large sheath size, which precludes the use of regular closure devices.The manta vascular closure device is a collagen plug-based vascular closure device for large bore percutaneous arterial interventions, which is normally used to close retrograde vascular access sites.A successful antegrade common femoral access site closure with the manta vascular closure device was described.Use of the manta vascular closure device simplifies large-bore antegrade common femoral artery access and avoids the need for surgical artery cutdown.The following complication was reported: a (b)(6) male patient with a popliteal artery aneurysm was treated by percutaneous endovascular stentgraft placement with 2 overlapping gore® viabahn® endoprostheses with propaten bioactive surface.The post-procedural period was complicated by acute stentgraft thrombosis, which resolved after intra-arterial thrombolysis.

Manufacturer Narrative

H6 evaluation codes investigation findings 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.Neither clinical images enabling direct assessment of product performance nor the product itself were returned for evaluation.The physician stated it could well be that the stents occluded because the patient had bent his knee too much and too long (during gardening).This caused kinking and thereby occlusion of the stent, but he is not sure, as he cannot find written information on that.With the information reported to gore this investigation is considered complete, the cause of the complaint was unable to be determined, investigation conclusion code 22 was included because thrombosis is a known inherent risk of the device, and code 4310 was added as a possible cause because the physician reported the patient had bent his knee too much and too long (during gardening).Per the physician this caused kinking and thereby occlusion of the stent, but this could not be confirmed.

• 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: gunter marte ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12347343
• MDR Text Key: 267441330
• Report Number: 2017233-2021-02294
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): Y
• Reporter Country Code: NL
• 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
• Report Date: 01/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/06/2021
• Device Catalogue Number: PAH111002E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2018
• 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: 68 YR
• Patient Sex: Male
• Patient Weight: 80 KG