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

Device Problem Insufficient Information (3190)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 04/19/2021

Event Type  Injury  

Manufacturer Narrative

As the devices remain implanted, no further investigations on the devices can be performed.The author was contacted to ask for more details like event dates, serial no.'s, implant dates as well as patient data and possible root causes.As date of event the date when the article was published was chosen, here (b)(6) 2021.The patient age and gender was not explicitly stated in the article (21 > 75 years and 15 > 80 years).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 article was reviewed: ¿adherence to instruction for use after endovascular repair of popliteal artery aneurysm¿ published by axel wrede in the vascular 0(0) 1-9.Endovascular repair (er) of popliteal artery aneurysm (paa) is an alternative to open repair.However, there is no standardized protocol for when to opt for er and the decision is therefore at the discretion of the clinician.This study aims to evaluate the adherence to the instruction for use (ifu) in patients undergoing er for paa and factors associated with stent graft patency at one year.The adherence to ifu provided by the manufacturer in 55 patients treated with 96 gore® viabahn® endoprosthesis with propaten bioactive surface for paa between 2009 and 2019 were retrospectively analyzed.The following outcome was reported after 30 days duplex follow-up: primary patency (%) 8 (88.9) (n=9) consistent with ifu and 36 (87.8) (n=41) not consistent with ifu.Secondary patency (%) 8 (88.9) (n=9) consistent with ifu and 37 (90.2) (n=41) not consistent with ifu.

Manufacturer Narrative

Multiple attempts were made to obtain additional information from the author about this event, like event date, serial no., implant dates as well as patient data and possible root cause.No additional information was provided; therefore, no further investigation could be performed.A review of the manufacturing records for the device could not be conducted because the serial/lot number remains unknown.Investigation conclusion: no additional information from the author was received which should include the following: a) unique device identification, b) clinical images enabling direct assessment of product performance, c) product, or d) detailed patient information, therefore this investigation is complete.Without a lot number or device serial number, the manufacturing date and/or production details cannot 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: 12451851
• MDR Text Key: 270782294
• Report Number: 2017233-2021-02363
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): Y
• Reporter Country Code: SW
• 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: 12/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/12/2021
• Initial Date FDA Received: 09/10/2021
• Supplement Dates Manufacturer Received: 11/15/2021
• Supplement Dates FDA 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