Model Number HARMONY-DCS |
Device Problems
Malposition of Device (2616); No Apparent Adverse Event (3189)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/14/2021 |
Event Type
Injury
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Manufacturer Narrative
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Other relevant device(s) are: product id: harmony-25, serial/lot #: (b)(4), ubd: 03-feb-2022, udi#: (b)(4), product analysis: the dcs was not returned, and the analysis on the valve is not yet complete.Conclusion: without the return of the dcs, and the analysis results for the valve not yet available, no definitive conclusion can be made 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 during the implant of this 25 millimeter (mm) transcatheter bioprosthetic pulmonary valve, the valve was deployed sideways and was retrieved from the patient using a 26 mm non-medtronic introducer sheath.The implanting team switched to the right pulmonary artery and the second transcatheter bioprosthetic pulmonary valve was deployed successfully.No additional adverse patient effects were reported.
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Manufacturer Narrative
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Medtronic received additional information that changed the event description and device relatedness of this previously reported event.There is no evidence to suggest the device caused or contributed to a death or serious injury.During the first deployment attempt of the initial valve, as the first and second nodes of the valve frame emerged from the delivery catheter system (dcs), a canted appearance was observed in the valve frame.The valve was slowly deployed further, and as further nodes (3-6) of the valve frame became visible, the team realized the valve did not straighten or realign as hoped.The canted frame changed the position of the valve frame which caused it to tilt, tip, be ¿sideways¿.The dcs was pulled into the introducer sheath and the valve was recaptured; the dcs was withdrawn from the patient and the valve was not implanted.No adverse patient effects were reported.H6.Device code; eval code method (the dcs was discarded); and annex f codes were updated.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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Manufacturer Narrative
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Correction g3: pma/510(k) #: p200046.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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Search Alerts/Recalls
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