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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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OSB Lead-Device Failure Study


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General
Application Number P030053 / PAS002
Current Plan Approved 11/17/2006
Study Name OSB Lead-Device Failure Study
General Study Protocol Parameters
Study Design Bench/Lab Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Adolescent: 13-18 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description The device failure study involves two components. The first component involves the collection of implant/surgery information and clinical data at the time of explantation. The second component involves visual inspection and physical testing of the explanted devices.
Study Population Description All explanted devices are to be returned to Mentor and analyzed and tested
Sample Size All returned devices are analyzed.
Data Collection An analysis was performed on the following categories to identify specific trends correlating to device failures: device type, size, clinical variables, visual observations, in-vivo time, surgical approach, device placement, incision size, pocket irrigation usage. Explanted devices underwent the following physical testing to assess the physical characteristics of the explanted devices: tension set, joint strength, ultimate elongation, gel cohesion.
Follow-up Visits and Length of Follow-up There is no patient follow-up in this study
Final Study Results
Interim Safety Information As of 8/31/09, 97 Core Gel devices have been explanted and returned for evaluation. Seventy-three of the 97 devices were returned intact and without abnormality. There were 8 devices that revealed edges with parallel striations that were deemed to be caused by sharp instruments. The cause of 14 device rents was unknown. A partial delamination of the patch was observed on 2 devices. For MemoryGel post-approval devices, A total of 1,545 implants (1,379 smooth and 166 textured) were retrieved worldwide from 11/17/06 through 8/31/09. Of the 1,545 retrieved devices, 664 were from US and 881 came from outside of US. There are 62 retrieved devices associated with the PAS patients and 1,483 devices associated with non-PAS patients or international patients. Of the 62 PAS devices returned, 35 were intact upon visual examination, 15 revealed rents with no indication as to their cause and 12 revealed rents with parallel striations indicative of sharp instrument damage. Of the remaining 1,483 non-PAS devices, 417 were intact upon visual examination, 636 revealed rents with parallel striations indicative of sharp instrument damage, 429 revealed rents with no indication as to their cause after examination.


OSB Lead-Device Failure Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
2 year report 11/16/2008 11/14/2008 On Time
3 year report 11/16/2009 11/16/2009 On Time
4 year report 11/16/2010 11/09/2010 On Time
5 year report 11/16/2011 11/09/2011 On Time
6 year report 11/15/2012 11/15/2012 On Time
7 year report 11/15/2013 11/12/2013 On Time
Change in Report Requirements/Study Status 09/10/2014   On Time

* Sponsor is reporting failure study data in the regular PMA Annual Report.



Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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