Model Number PB 10 |
Device Problem
Fracture (1260)
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Patient Problems
Aortic Valve Stenosis (1717); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/01/2010 |
Event Type
malfunction
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Manufacturer Narrative
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Citation: vezmar et al.Percutaneous pulmonary valve implantation in the young: 2-year follow-up.Jacc cardiovasc interv.2010 apr;3(4):439-48.Doi: 10.1016/j.Jcin.2010.02.003.Earliest date of publish used for event date in b3.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 physiological and clinical consequences of percutaneous pulmonary valve implantation (ppvi) in patients with chronic right ventricular outflow tract (rvot) obstruction and volume overload.All data werecollected from a single center between october 2005 and december 2008.The study population included 28 patients (predominantly male, mean age 14.9 years, mean weight 57.7 kg).Multiple manufacturer¿s devices were implanted in the study population; medtronic products included melody (n=28), hancock conduit (n = 10) and hancock bioprosthetic valve (n=6).No serial numbers were provided.Among melody valve patients, one valve frame stent fracture occurred in which the valve remained competent but subsequently required elective surgical intervention.Based on the available information medtronic product was directly associated with the malfunction.No additional adverse patient effects or product performance issues were reported.
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Manufacturer Narrative
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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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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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Additional information received from the physician/author stated that for one patient the melody valve was positioned within a bare-metal stent (manufacturer/brand not provided) to reinforce the conduit that abutted the sternum.At three months post-procedure compression led to stent fracture of both the bare-metal stent and the melody valve, and consequently recurrent stenosis.A small component of the bare-metal stent embolized to the left pulmonary artery without obstruction, whereas the melody valve remained competent.The patient later underwent elective surgical repair.Also, the physician/author stated that unique device identifiers were unknown and that no medtronic devices were available for return.
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Search Alerts/Recalls
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