Model Number PB1016 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
High Blood Pressure/ Hypertension (1908)
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Event Date 12/13/2018 |
Event Type
Injury
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Manufacturer Narrative
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Product analysis: the product remains implanted; therefore, no product analysis can be performed.Conclusion: without return of the product, no definitive conclusions could be drawn regarding the clinical observation.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 that approximately three months and three weeks after the implant of this transcatheter bioprosthetic pulmonary valve (tbpv) that had been implanted valve-in-valve into another tbpv, increased right ventricle (rv) pressure were measured to be 53 mmhg.Nine months post implant the rv pressure had increased to 62 mmhg.One year and three months after the valve-in-valve, the rv pressure had increase to 80 mm hg.One year and six months after the implant, the valves were pre-stented and a third melody was implanted.No additional adverse patient effects were reported.
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Manufacturer Narrative
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Additional information was received that the second tbpv was implanted valve-in-valve into a valve that was not marketed/commercially distributed and not similar to a device marketed/commercially distributed.The initial device was implanted during an investigational clinical trial.Corrected the date of the event to the date of the second melody valve implant, (b)(6) 2018 that was reported correctly on the initial report submitted on 2019-01-11.Corrected the pt.Identifier to (b)(6), that was reported correctly on the initial report submitted on 2019-01-11.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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Manufacturer Narrative
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Additional information was received that prior to the intervention, right ventricle pressures were measured at 90 mmhg.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.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 in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees 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 reporting pursuant to part 803.Medtronic objects to the use of these words and others like it 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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Search Alerts/Recalls
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