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 Problems Aneurysm (1708); Insufficient Information (4580)

Event Date 03/21/2021

Event Type  Injury  

Manufacturer Narrative

Date of event was determined as date when literature article was published, here (b)(6) 2021.As patient age the mean age (b)(6) years was determined and as gender male as mentioned in the article.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.Device evaluated by mfr: as the device remains implanted, an investigation on the device cannot be performed.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 publication was reviewed: ¿results after open and endovascular repair of popliteal aneurysm: a matched comparison within a population based cohort¿ published by anne cervin in the european journal of vascular and endovascular surgery volume 61, issue 6, june 2021, (pages 988-997).The aim of this study was to identify factors affecting the outcome after open surgical (osr) and endovascular (er) repair of popliteal artery aneurysm (pa) in comparable cohorts.A matched comparison in a national, population-based cohort of 592 legs treated for pa (2008 e 2012), with long term follow up.Registry data from 899 pa patients treated in 2014 e 2018 were analysed for time trends.The 77 legs treated by er were matched, by indication, with 154 legs treated with osr.Medical records and imaging were collected.Analysed risk factors were anatomy, comorbidities, and medication.Elongation and angulations were examined in a core lab.The main outcome was occlusion.The following adverse events were reported: permanent occlusion within 30 days occurred at 8 patients.As re-interventions there were thrombolysis, conversion/new bypass and major amputation.

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: 12258579
• MDR Text Key: 264478020
• Report Number: 2017233-2021-02210
• 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: 11/17/2021

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: 07/05/2021
• Initial Date FDA Received: 08/02/2021
• Supplement Dates Manufacturer Received: 10/19/2021
• Supplement Dates FDA Received: 11/17/2021
• 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: 73 YR
• Patient Sex: Male