Model Number PB1018 |
Device Problems
Fracture (1260); Gradient Increase (1270)
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Patient Problems
Pulmonary Regurgitation (2023); Pulmonary Valve Stenosis (2024)
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Event Date 02/25/2012 |
Event Type
Injury
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Manufacturer Narrative
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Date of event: (b)(6) 2012 was an approximation as the re-dilation was reported to have occurred in (b)(6) of 2012.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 this transcatheter pulmonary valve (tpv), was implanted in a previously placed right ventricle (rv) to pulmonary artery (pa) conduit (20 millimeter (mm) pulmonary graft), in a patient that had complete neonatal repair, truncus arteriosus and a right-sided aortic arch (raa).Approximately one year and seven months following the placement of the valve, angiography showed that the valve was found to be no longer circular and type ii fractures were present.A re-dilation to 22mm was performed, due to tpv compression and recurrent pulmonary stenosis (ps).Approximately eight year and seven months following the placement of the valve, angiography showed moderate pulmonary insufficiency with severe stenosis, and a 38 mm of mercury (hg) across the valve.Multiple stents placed in the right ventricular outflow tract (rvot) for the fractured valve, along with a second tpv implanted valve-in-valve.No additional adverse patient effects were reported.
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Manufacturer Narrative
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Conclusion: the device history record was reviewed and showed that this valve met all manufacturing specifications for product released to distribution.There was no deviation identified in manufacturing process that could be related to this event.Immobile leaflet is a common failure mode (mechanism) which could lead to stenosis/high gradients.Pannus overgrowth is one of the common causes for this failure mode.However, without the failure mechanism and the return of the valve for analysis, a root cause of the stenosis could not be determined.Based on clinical data and literature, melody stent fractures are a 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.It is likely that the reported stent fracture was a type ii fracture with loss of integrity because a new valve was put in place.In this case, with the received information, the stent fracture was caused by the balloon aortic valvuloplasty (bav), which was performed to improve the right ventricle (rv) to pulmonary artery (pa) gradient.In addition, the reported insufficiency and stenosis could be due to the stent fracture.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Date of event: updated to (b)(6) 2012.Additional information reported that an echocardiogram performed one year, four months and fifteen days following the placement of the valve showed mild to moderate rv to pa conduit stenosis with no regurgitation.The angiography that identified the fracture and the re-dilation of the valve occurred one year and eight months and eight days following the placement of the valve.Following the balloon aortic valvuloplasty (bav), a new fracture was observed.No additional adverse patient effects were reported.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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B5.Additional information reported that the fracture seen following the balloon aortic valvuloplasty (bav), one year and eight months and eight days following the placement of the valve, was caused by the bav.No treatment was provided at that time, as the rv to pa gradient improved from 30 to 12mmhg.The non-medtronic balloon that caused the fracture was a 22mm x 2cm balloon, that was inflated once to 8 standard atmospheres (atm).The inflation time, inflation device and the patient¿s annulus dimensions were not documented.No additional adverse patient effects were reported.D3.Suspect medical device mfr name: corrected back to medtronic heart valves division.This was correctly reported in the initial report on 2019-05-30.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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