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U.S. Department of Health and Human Services

522 Postmarket Surveillance Studies

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CENTER FOR DEVICES AND RADIOLOGICAL HEALTH

DIVISION OF EPIDEMIOLOGY

"PROTECTING & PROMOTING PUBLIC HEALTH THROUGH DEVICE SURVEILLANCE AND RESEARCH"



WELCOME TO THE 522 POSTMARKET SURVEILLANCE STUDIES WEBPAGE

 

 

 

 

            

Graft Patency and Technical Failure


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General
522 Number / Requirement Number PS060003 / PSS001
Current Plan Approved 05/22/2007
Study Name Graft Patency and Technical Failure
Root Document Number K040832  K053524  K063644  K070548 
General Study Protocol Parameters
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description A prospective, multi-center, registry will be used to obtain data for the currently manufactured C-Port devices. The one-year graft occlusion rate for the C-Port device will be compared with an a priori rate taken from the published results of the PREVENT IV trial, which is 26.63% (597/2,242).
Study Population Description Subjects who meet indication criteria for device

Sample Size 100 patients, 8 sites

Data Collection Primary: Failure of the anastomoses of the index grafts assessed in subjects by Gated 64-slice CT scan at 12-months following surgery. Secondary: Technical failure rates for anastomoses produced with the C-Port device. Technical success rate of hand-sewn anastomoses following technical failures with the C-Port device, as well as technical failure rate and clinical sequelae of the hand-sewn anastomoses at one year. Retrospective evaluation to establish the types of technical failures and adverse events associated with the original C-Port device, by reviewing available postmarket feedback data.

Follow-up Visits and Length of Follow-up Length of f/u 1 year

Final Study Results
Interim Safety Information 10% failure rate for anastomoses of the index grafts

2.6% technical failure rate



Graft Patency and Technical Failure Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6-mo report 05/11/2009 05/07/2009 On Time
1.5-year report 05/11/2010 06/10/2010 Overdue/Received
2-year report 11/10/2010 11/10/2010 On Time
30 month report 05/14/2011 05/16/2011 Overdue/Received
33 month report 08/12/2011 08/16/2011 Overdue/Received
3-year report 11/10/2011 11/10/2011 On Time
39 month report 02/08/2012 02/08/2012 On Time
42 month report 05/14/2012 05/11/2012 On Time
45 month report 08/12/2012 08/13/2012 Overdue/Received
4-year report 11/09/2012 11/08/2012 On Time
51 mth report & report schedule change req 02/08/2013 02/11/2013 Overdue/Received
54 months report 05/10/2013 05/09/2013 On Time
63 month report 02/07/2014 02/07/2014 On Time
69 month report 03/17/2015 03/17/2015 On Time
Final Report 06/30/2015 07/22/2015 Overdue/Received


  • The 522 Postmarket Surveillance Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated under section 522 of the Federal Food, Drug and Cosmetic Act. The program helps ensure that well-designed 522 postmarket surveillance (PS) studies are conducted effectively and efficiently and in the least burdensome manner.
  • In May 2008, the oversight responsibility of the 522 Postmarket Surveillance Studies Program was transferred to the Division of Epidemiology (DEPI) of the Office of Surveillance and Biometrics (OSB)/Center for Devices and Radiological Health (CDRH). DEPI continues to build the 522 program.
  • CDRH has established an automated internal tracking system that efficiently identifies the reporting status of active 522 PS studies based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH's effort to ensure that all 522 PS commitments are fulfilled in a timely manner.
  • In addition, CDRH launched this publicly available webpage to keep all stakeholders informed of the progress of each 522 PS study. The webpage displays general information regarding each study, as well as the overall study status (based on protocol-driven timelines and adequacy of the data) and the applicant's reporting status for each submission due.

Links

Contact Information

Cheryl Reynolds
Project Manager, 522 Postmarket Surveillance (PS) Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4108
Silver Spring, MD 20993-0002

Phone: (301) 796-7033
Fax: (301) 847-8140
Cheryl.Reynolds@fda.hhs.gov
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