Post-market surveillance to detect adverse events associated with Melody® valve implantation. (10th November 2016)

• Record Type: Journal Article
• Authors: Hill, Kevin D.; Goldstein, Bryan H.; Angtuaco, Michael J.; Chu, Patricia Y.; Fleming, Gregory A.
• Is Part Of: Cardiology in the young. Volume 27:Number 6(2017)
• Page Start: 1090
• Page End: 1097
• Publication Date: 2016-11-10
• Subjects: MAUDE database, -- device safety, -- transcatheter pulmonary valve; Pediatric cardiology -- Periodicals; 618.9212
• DOI: 10.1017/S1047951116002092
• Languages: English
• ISSNs: 1047-9511

Abstract

Abstract: Objective: The aim of this study was to describe previously unrecognised or under-recognised adverse events associated with Melody ® valve implantation. Background: In rare diseases and conditions, it is typically not feasible to conduct large-scale safety trials before drug or device approval. Therefore, post-market surveillance mechanisms are necessary to detect rare but potentially serious adverse events. Methods: We reviewed the United States Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database and conducted a structured literature review to evaluate adverse events associated with on- and off-label Melody ® valve implantation. Adverse events were compared with those described in the prospective Investigational Device Exemption and Post-Market Approval Melody ® transcatheter pulmonary valve trials. Results: We identified 631 adverse events associated with "on-label" Melody ® valve implants and 84 adverse events associated with "off-label" implants. The most frequent "on-label" adverse events were similar to those described in the prospective trials including stent fracture (n=210) and endocarditis (n=104). Previously unrecognised or under-recognised adverse events included stent fragment embolisation (n=5), device erosion (n=4), immediate post-implant severe valvar insufficiency (n=2), and late coronary compression (n=2 cases at 5 days and 3 months after implantation). Under-recognised adverse events associated with off-label implantation included early valve failure due to insufficiency when implanted in the tricuspid position (n=7) and embolisation with percutaneous implantation in the mitral position (n=5). Conclusion: Post-market passive surveillance does not demonstrate a high frequency of previously unrecognised serious adverse events with "on-label" Melody ® valve implantation. Further study is needed to evaluate safety of "off-label" uses.