Citation: otero luna a, et al.Successful transcatheter balloon valvuloplasty of previously placed transcatheter pulmonary valve years after initial placement: a report of 2 cases.Pediatric cardiology.Abstracts: pics-aics virtual symposium september 10¿12, 2020; 41:1256-1257.Doi: 10.1007/s00246-020-02408-w.Published: 31 july 2020.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.
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Medtronic received information from a literature abstract regarding two cases of transcatheter pulmonary valve stenosis treated with balloon valvuloplasty.Patient two: a (b)(6) male patient with a history of with complete atrioventricular canal defect with tetralogy of fallot.At (b)(6), the patient underwent successful transcatheter pulmonary valve replacement with an 18 mm medtronic melody (unique device identifier number not provided) for right ventricular outflow tract patch stenosis.Four years later, at approximately (b)(6), severe stenosis (peak 70 mmhg, mean 38 mmhg) across the melody was noted.Subsequently, a post-dilation was performed using a 20 mm balloon.Afterward, a gradient of 2 mmhg and mild pulmonary insufficiency were observed.No additional adverse patient effects or product performance issues were reported.
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