Model Number PB 10 |
Device Problem
Insufficient Information (3190)
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Patient Problems
Arrhythmia (1721); Non specific EKG/ECG Changes (1817); Idioventricular Rhythm (1923); Ventricular Tachycardia (2132)
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Event Date 12/27/2017 |
Event Type
Injury
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Manufacturer Narrative
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Citation: simmons m., et al.Ventricular arrhythmias immediately following transcatheter pulmonary valve implantation: a cause for concern? catheter cardiovasc interv.2018 apr 1;91(5):920-926.Doi: 10.1002/ccd.27454.Pmid: (b)(6).Epub 2017 dec 27.Earliest date of publish used for event date.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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Event Description
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Medtronic received information via literature regarding the occurrence of ventricular arrhythmias after transcatheter pulmonary valve implantation (tpvi).All data were retrospectively collected from a single center between may 2011 and march 2016.The study population included 75 adult and pediatric patients (predominantly male, mean age 19 years, mean weight 60 kg), 65 of whom were implanted with medtronic melody bioprosthetic valves (no serial numbers provided).Among all patients, adverse events included: post-operative ventricular arrhythmias, including premature ventricular contractions, bigeminy, ectopic beats, ventricular tachycardia and idioventricular rhythms.Patients required delayed hospital discharges or re-admissions, anti-arrhythmic medications and implantable cardioverter defibrillator (icd) placements.Based on the available information medtronic product may have been associated with the adverse events.No additional adverse patient effects or product performance issues were reported.
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Manufacturer Narrative
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See b5 for additional information.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was further reported that only six medtronic melody patients experienced premature ventricular contractions (pvcs) and/or non-sus tained ventricular tachycardia (vt).The patients were treated only with anti-arrhythmic medication to resolve the arrhythmias.No further patient complications have been reported as a result of this event.
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Search Alerts/Recalls
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