Citation: kerst et al.Intervention: murphy¿s law in the cath lab: tuning a disharmonic melody into a harmonic pulmonary and tricuspid concert.Cardiology in the young: volume 26, supplement 1, pages s1¿s181.50th annual meeting of the association for european paediatric and congenital cardiology (aepc).Rome, italy.June 1-4, 2016.Doi:10.1017/s1047951116000500.Earliest date of publish used for date of event.No unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported.Without return of the product no definitive conclusion can be made regarding the clinical observations.If information is provided in the future, a supplemental report will be issued.
|
Medtronic received information via literature regarding a (b)(6) year-old male patient with severe right heart failure caused by severe stenosis of the surgically implanted pulmonary homograft.The patient underwent a procedure to implant a medtronic melody bioprosthetic valve delivered by the ensemble catheter system (unique device identifier numbers not provided).Following preparation of the pulmonary ¿landing zone¿ with placement of three non-medtronic stents, the ensemble delivery catheter with the pre-mounted melody valve could not be advanced to the targeted pulmonary position.Eventually, several troubleshooting methods resulted in the access and successful placement of two melody valves.The first melody valve was balloon expanded into a funnel-like shape followed by successful placement of a second melody valve yielding ¿two melodies in harmonic concert¿ per the physician/authors.No additional adverse patient effects or product performance issues were reported.The exact positioning of the two melody valves was not stated, however the description suggests a valve-in-valve placement.No additional adverse patient effects or product performance issues were reported.
|