Post-market surveillance to detect adverse events associated with Melody® valve implantation.
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).


CONCLUSIONS
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.
1Department of Pediatrics, Duke University Medical Center,Durham,North Carolina,United States of America.
Kevin D
KD
Hill
2The Heart Institute,Cincinnati Children's Hospital Medical Center,Cincinnati,Ohio,United States of America.
Bryan H
BH
Goldstein
3Department of Pediatrics, University of Arkansas for Medical Sciences,Little Rock,Arkansas,United States of America.
Michael J
MJ
Angtuaco
1Department of Pediatrics, Duke University Medical Center,Durham,North Carolina,United States of America.
Patricia Y
PY
Chu
1Department of Pediatrics, Duke University Medical Center,Durham,North Carolina,United States of America.
Gregory A
GA
Fleming
D001705:Bioprosthesis / Q000009:adverse effects*; D006328:Cardiac Catheterization; D006349:Heart Valve Diseases / Q000601:surgery*; D006350:Heart Valve Prosthesis / Q000009:adverse effects; D006801:Humans; D011358:Product Surveillance, Postmarketing; D011474:Prosthesis Design; D011475:Prosthesis Failure; D011664:Pulmonary Valve / Q000601:surgery*; D014481:United States; D014486:United States Food and Drug Administration
MAUDE database; device safety; transcatheter pulmonary valve