Model Number PB1018 |
Device Problem
Fracture (1260)
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Patient Problem
Pulmonary Valve Stenosis (2024)
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Event Date 07/29/2020 |
Event Type
Injury
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Manufacturer Narrative
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Product analysis: the device remains implanted, therefore no product analysis can be performed. conclusion: without the return of the product, 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 approximately five years and two months following the implant of this transcatheter pulmonary bioprosthetic valve, pulmonary stenosis was observed and a type 1 stent fracture occurred.A new valve was subsequently implanted valve-in-valve.No additional adverse patient effects were reported. .
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Manufacturer Narrative
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Additional information was received that the gradient following the implant of the second valve was 20 mmhg.The post implant bav was performed to reduce this gradient.No additional adverse patient effects were reported. updated b5-event description.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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Conclusion: the device history record was reviewed and showed that this product met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.Still and movie photo clips related to this event were received.The photos and movie confirm there are stent fractures seen in the stent frames.Based on clinical data and literatures, stent fractures are known phenomenon.Prominent mechanical stresses on the outflow tract stent, such as compression between the anterior chest wall and heart, appear to be associated with an increased risk of stent fracture.Based on the risk analysis, immobile leaflet (incomplete leaflet opening) is a common failure mode (mechanism) which could lead to stenosis.Pannus overgrowth and calcification would be the common cause for immobile leaflet.In addition, the stent fracture may have led to the reported stenosis.However, with the limited information available and without the device returned for analysis, a conclusive cause of the event cannot be determined.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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