MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION COREVALVE TRANSCATHETER AORTIC VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV

Model Number CRS

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 11/05/2018

Event Type  Death  

Manufacturer Narrative

Tvt registry exemption number: e2014038.Quarterly reporting period: q4 2018 total number of events being summarized: 472 under the terms and conditions of the registry, anonymized patient demographics details and limited details were provided regarding the adverse events and outcomes.The reported event information did not include any device-specific identifying information, location where the events occurred or the specific dates of the events.Without such information, it cannot be determined if any of these events were previously reported to medtronic or the fda maude database, or if any devices were explanted and returned to medtronic for analysis.The listed date of death and event date is the date the information was received by medtronic.The date of death was noted as the date of awareness due to the de-identified nature of the data.If information is provided in the future, a supplemental report will be issued.

Event Description

This report summarizes 472 death events.Medtronic received information regarding patient/device events via a third-party post-implant device registry (the society of thoracic surgeons/american college of cardiology transcatheter valve therapy registry).The information in this report was provided to medtronic in a de-identified format, and has been organized into summaries of observations related to patient deaths and serious injuries.

Manufacturer Narrative

Exemption number: e2014038.Quarterly reporting period: q4 2018.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Exemption number: e2014038 quarterly reporting period: q4 2018 if information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Exemption number: e2014038.Quarterly reporting period: q4 2018.The updated spreadsheet contains additional, amended, corrected or deleted information for previously-reported corevalve tvt device implant registry patient events.New/updated information is highlighted by color coding.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.(b)(4).

Manufacturer Narrative

Exemption number: e2014038.Quarterly reporting period: q4 2018.The attached updated spreadsheet contains additional, amended, corrected or deleted information for previously-reported corevalve tvt device implant registry patient events.New/updated information is highlighted by color coding.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.

Manufacturer Narrative

In accordance with modifications to summary reporting registry exemption e2014038 received on june 2, 2020, the following information was received from the sts/acc tvt registry for the corevalve system.The tvt registry subsequently removed the following data: one event of the patient expiring from cause of death cardiac, one event of the patient expiring from cause of death infection.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.

Manufacturer Narrative

In accordance with modifications to summary reporting registry exemption e2014038 received on february 7, 2020, the following information was received from the sts/acc tvt registry for the corevalve system the tvt registry subsequently amended or removed the sts/acc tvt amended data: one event of a patient cause of death of unknown to cause of death neurological.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.

Manufacturer Narrative

In accordance with modifications to summary reporting registry exemption e2014038 received on (b)(6) 2020, the following information was received from the sts/acc tvt registry for the corevalve system.The tvt registry subsequently removed the following data: one event of the patient expiring from cause of death neurologic.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.

Manufacturer Narrative

In accordance with modifications to summary reporting registry exemption e2014038 received on (b)(6) 2021, the following information was received from the sts/acc tvt registry for the corevalve system.The tvt registry subsequently amended the following data: one event of patient death, cause of death unknown to cause of death vascular.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.

Manufacturer Narrative

In accordance with modifications to summary reporting registry exemption e2014038 received on may 6, 2021, the following information was received from the sts/acc tvt registry for the corevalve system.The tvt registry subsequently removed the following data: the tvt registry or reporting facility subsequently corrected/changed the report to indicate the patient's death occurred on day 358 post-implant of the valve; cause of death unknown.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.

Event Description

Unique complaint id number,initial or supplement,type of event,tte in days,device brand name,medical device identifier,device codes
702945344-1206638-10,i,d,184,corevalve tm evolut tm r transcatheter aortic valve,evolutr-29-us,c53269
702945344-1608317-10,i,d,286,evolut pro system,29mm tav evolutpro-29-us,c53269
702945344-1665758-10,i,d,154,corevalve evolut r tav,evolutr-34-us,c53269
702945344-1676567-10,i,d,153,corevalve evolut r tav,evolutr-34-us,c53269
702945344-1712104-10,i,d,140,evolut pro system,29mm tav evolutpro-29-us,c53269
702945344-1725142-10,i,d,45,corevalve evolut r tav,evolutr-34-us,c53269
702945344-2262360-10,i,d,8,corevalve evolut r tav,evolutr-34-us,c53269
702945344-2440541-10,i,d,805,corevalve tm evolut tm r transcatheter aortic valve,evolutr-23-us,c53269
702945344-2750174-10,i,d,5,corevalve system; tav,mcs-p3-26-aoa-us,c53269
702945344-3157343-10,i,d,197,evolut pro system,26mm tav evolutpro-26-us,c53269
702945344-3198215-10,i,d,1286,corevalve system;tav,mcs-p3-29-aoa,c53269
702945344-3415490-10,i,d,101,corevalve evolut r tav,evolutr-34-us,c53269
702945344-3501129-10,i,d,n/a,corevalve system; tav,mcs-p3-26-aoa-us,c53269
702945344-3571775-10,i,d,0,enveo pro loading system,l-envpro-16-us,c53269;c62814
702945344-3628891-10,i,d,91,corevalve system;tav,mcs-p3-31-aoa,c53269
702945344-3635748-10,i,d,12,corevalve system; tav,mcs-p3-29-aoa-us,c53269
702945344-3638337-10,i,d,127,corevalve system; tav,mcs-p3-31-aoa-us,c53269
702945344-3665776-10,i,d,345,evolut pro system,26mm tav evolutpro-26-us,c53269
702945344-3797449-10,i,d,8,corevalve tm evolut tm r transcatheter aortic valve,evolutr-23-us,c53269
702945344-3817082-10,i,d,178,corevalve tm evolut tm r transcatheter aortic valve,evolutr-26-us,c53269
702945344-3817595-10,i,d,73,corevalve tm evolut tm r transcatheter aortic valve,evolutr-29-us,c53269
702945344-3856928-10,i,d,793,corevalve tm evolut tm r transcatheter aortic valve,evolutr-29-us,c53269
702945344-3860453-10,i,d,284,corevalve tm evolut tm r transcatheter aortic valve,evolutr-29-us,c53269
702945344-3910889-10,i,d,237,evolut pro system,29mm tav evolutpro-29-us,c53269
702945344-3973120-10,i,d,n/a,corevalve tm evolut tm r transcatheter aortic valve,evolutr-29-us,c53269
702945344-3980775-10,i,d,638,corevalve tm evolut tm r transcatheter aortic valve,evolutr-29-us,c53269
702945344-3990059-10,i,d,31,evolut pro system,29mm tav evolutpro-29-us,c53269
702945344-4022644-10,i,d,n/a,corevalve tm evolut tm r transcatheter aortic valve,evolutr-29-us,c53269
702945344-4023937-10,i,d,168,corevalve evolut r tav,evolutr-34-us,c53269
702945344-4050023-10,i,d,698,corevalve tm evolut tm r transcatheter aortic valve,evolutr-29-us,c53269
702945344-4098506-10,i,d,262,corevalve tm evolut tm r transcatheter aortic valve,evolutr-29-us,c53269
702945344-4138216-10,i,d,n/a,corevalve system; tav,mcs-p3-31-aoa-us,c53269
702945344-4138216-10,s,d,,,,
702945344-4150774-10,i,d,298,corevalve tm evolut tm r transcatheter aortic valve,evolutr-29-us,c53269
702945344-4153553-10,i,d,5,corevalve tm evolut tm r transcatheter aortic valve,evolutr-26-us,c53269
702945344-4162171-10,i,d,n/a,corevalve tm evolut tm r transcatheter aortic valve,evolutr-29-us,c53269
702945344-4177558-10,i,d,203,corevalve tm evolut tm r transcatheter aortic valve,evolutr-29-us,c53269
702945344-4177684-10,i,d,269,corevalve tm evolut tm r transcatheter aortic valve,evolutr-23-us,c53269
702945344-4192476-10,i,d,n/a,corevalve evolut r tav,evolutr-34-us,c53269
702945344-4205189-10,i,d,160,evolut pro system,29mm tav evolutpro-29-us,c53269
702945344-4216542-10,i,d,47,corevalve evolut r tav,evolutr-34-us,c53269
702945344-4217417-10,i,d,357,corevalve evolut r tav,evolutr-34-us,c53269
702945344-4219742-10,i,d,188,enveo tm r loading system,ls-enveor2629us,c53269
702945344-4223890-10,i,d,148,corevalve tm evolut tm r transcatheter aortic valve,evolutr-29-us,c53269
702945344-4228276-10,i,d,231,corevalve tm evolut tm r transcatheter aortic valve,evolutr-26-us,c53269
702945344-4232731-10,i,d,258,corevalve tm evolut tm r transcatheter aortic valve,evolutr-29-us,c53269
702945344-4233483-10,i,d,270,corevalve tm evolut tm r transcatheter aortic valve,evolutr-29-us,c53269
702945344-4237493-10,i,d,146,corevalve evolut r tav,evolutr-34-us,c53269
702945344-4237585-10,i,d,78,corevalve tm evolut tm r transcatheter aortic valve,evolutr-29-us,c53269
702945344-4243255-10,i,d,229,corevalve tm evolut tm r transcatheter aortic valve,evolutr-29-us,c53269
702945344-4246594-10,i,d,345,corevalve tm evolut tm r transcatheter aortic valve,evolutr-29-us,c53269
702945344-4252944-10,i,d,0,corevalve tm evolut tm r transcatheter aortic valve,evolutr-29-us,c53269
702945344-4256337-10,i,d,419,corevalve evolut r tav,evolutr-34-us,c53269
702945344-4272748-10,i,d,340,corevalve tm evolut tm r transcatheter aortic valve,evolutr-26-us,c53269
702945344-4272797-10,i,d,48,corevalve tm evolut tm r transcatheter aortic valve,evolutr-26-us,c53269
702945344-4272909-10,i,d,325,evolut pro system,29mm tav evolutpro-29-us,c53269
702945344-4274149-10,i,d,205,corevalve tm evolut tm r transcatheter aortic valve,evolutr-29-us,c53269
702945344-4276235-10,i,d,134,corevalve tm evolut tm r transcatheter aortic valve,evolutr-26-us,c53269
702945344-4280275-10,i,d,324,corevalve tm evolut tm r transcatheter aortic valve,evolutr-23-us,c53269
702945344-4285168-10,i,d,106,corevalve tm evolut tm r transcatheter aortic valve,evolutr-29-us,c53269
702945344-4294933-10,i,d,96,corevalve tm evolut tm r transcatheter aortic valve,evolutr-29-us,c53269
702945344-4296521-10,i,d,65,corevalve tm evolut tm r transcatheter aortic valve,evolutr-23-us,c53269
702945344-4297907-10,i,d,63,evolut pro system,26mm tav evolutpro-26-us,c53269
702945344-4298302-10,i,d,315,corevalve tm evolut tm r transcatheter aortic valve,evolutr-26-us,c53269
702945344-4298966-10,i,d,191,corevalve tm evolut tm r transcatheter aortic valve,evolutr-29-us,c53269
702945344-4298982-10,i,d,341,corevalve tm evolut tm r transcatheter aortic valve,evolutr-29-us,c53269
702945344-4299159-10,i,d,314,corevalve tm evolut tm r transcatheter aortic valve,evolutr-29-us,c53269
702945344-4299319-10,i,d,202,corevalve tm evolut tm r transcatheter aortic valve,evolutr-26-us,c53269
702945344-4299406-10,i,d,421,corevalve tm evolut tm r transcatheter aortic valve,evolutr-29-us,c53269
702945344-4302948-10,i,d,38,corevalve evolut r tav,evolutr-34-us,c53269
702945344-4303124-10,i,d,393,corevalve evolut r tav,evolutr-34-us,c53269
702945344-4304758-10,i,d,174,corevalve evolut r tav,evolutr-34-us,c53269
702945344-4305740-10,i,d,425,corevalve evolut r tav,evolutr-34-us,c53269
702945344-4306009-10,i,d,90,corevalve tm evolut tm r transcatheter aortic valve,evolutr-29-us,c53269
702945344-4307541-10,i,d,393,corevalve tm evolut tm r transcatheter aortic valve,evolutr-23-us,c53269
702945344-4308190-10,i,d,188,corevalve evolut r tav,evolutr-34-us,c53269
702945344-4308881-10,i,d,416,corevalve tm evolut tm r transcatheter aortic valve,evolutr-29-us,c53269
702945344-4323552-10,i,d,302,corevalve evolut r tav,evolutr-34-us,c53269
702945344-4323552-10,s,d,,,,
702945344-4323728-10,i,d,177,corevalve tm evolut tm r transcatheter aortic valve,evolutr-23-us,c53269
702945344-4325180-10,i,d,256,corevalve evolut r tav,evolutr-34-us,c53269
702945344-4327733-10,i,d,241,corevalve tm evolut tm r transcatheter aortic valve,evolutr-29-us,c53269
702945344-4328250-10,i,d,153,evolut pro system,29mm tav evolutpro-29-us,c53269
702945344-4329813-10,i,d,94,corevalve evolut r tav,evolutr-34-us,c53269
702945344-4330222-10,i,d,255,corevalve evolut r tav,evolutr-34-us,c53269
702945344-4333454-10,i,d,370,corevalve evolut r tav,evolutr-34-us,c53269
702945344-4335415-10,i,d,n/a,corevalve evolut r tav,evolutr-34-us,c53269
702945344-4344734-10,i,d,358,evolut pro system,29mm tav evolutpro-29-us,c53269
702945344-4345785-10,i,d,342,enveo tm r delivery catheter system,enveor-us,c53269
702945344-4346218-10,i,d,169,corevalve tm evolut tm r transcatheter aortic valve,evolutr-29-us,c53269
702945344-4347667-10,i,d,177,corevalve evolut r tav,evolutr-34-us,c53269
702945344-4350041-10,i,d,151,corevalve tm evolut tm r transcatheter aortic valve,evolutr-29-us,c53269
702945344-4351354-10,i,d,308,corevalve tm evolut tm r transcatheter aortic valve,evolutr-26-us,c53269
702945344-4352388-10,i,d,50,evolut pro system,26mm tav evolutpro-26-us,c53269
702945344-4353011-10,i,d,433,enveo tm r delivery catheter system,enveor-us,c53269
702945344-4353105-10,i,d,196,corevalve tm evolut tm r transcatheter aortic valve,evolutr-26-us,c53269
702945344-4358889-10,i,d,n/a,evolut pro system,29mm tav evolutpro-29-us,c53269
702945344-4359171-10,i,d,201,corevalve tm evolut tm r transcatheter aortic valve,evolutr-26-us,c53269
702945344-4359267-10,i,d,426,evolut pro system,29mm tav evolutpro-29-us,c53269
702945344-4359797-10,i,d,84,evolut pro system,26mm tav evolutpro-26-us,c53269
702945344-4363715-10,i,d,285,corevalve evolut r tav,evolutr-34-us,c53269
702945344-4365235-10,i,d,230,corevalve tm evolut tm r transcatheter aortic valve,evolutr-26-us,c53269
702945344-4367549-10,i,d,389,evolut pro system,29mm tav evolutpro-29-us,c53269
702945344-4367549-10,s,d,,,,
702945344-4368614-10,i,d,328,corevalve tm evolut tm r transcatheter aortic valve,evolutr-29-us,c53269
702945344-4369754-10,i,d,122,corevalve evolut r tav,evolutr-34-us,c53269
702945344-4371898-10,i,d,47,corevalve evolut r tav,evolutr-34-us,c53269
702945344-4372068-10,i,d,182,corevalve tm evolut tm r transcatheter aortic valve,evolutr-29-us,c53269
702945344-4373951-10,i,d,127,corevalve tm evolut tm r transcatheter aortic valve,evolutr-29-us,c53269
702945344-4374516-10,i,d,260,corevalve tm evolut tm r transcatheter aortic valve,evolutr-29-us,c53269
702945344-4376817-10,i,d,279,evolut pro system,29mm tav evolutpro-29-us,c53269
702945344-4378807-10,i,d,5,evolut pro system,26mm tav evolutpro-26-us,c53269
702945344-4378807-10,s,d,,,,
702945344-4380035-10,i,d,234,corevalve tm evolut tm r transcatheter aortic valve,evolutr-26-us,c53269
702945344-4380324-10,i,d,361,corevalve tm evolut tm r transcatheter aortic valve,evolutr-29-us,c53269
702945344-4381816-10,i,d,n/a,corevalve tm evolut tm r transcatheter aortic valve,evolutr-23-us,c53269
702945344-4382079-10,i,d,115,corevalve evolut r tav,evolutr-34-us,c53269
702945344-4382325-10,i,d,366,evolut pro system,29mm tav evolutpro-29-us,c53269
702945344-4383033-10,i,d,107,corevalve tm evolut tm r transcatheter aortic valve,evolutr-23-us,c53269
702945344-4384290-10,i,d,409,corevalve evolut r tav,evolutr-34-us,c53269
702945344-4384505-10,i,d,339,evolut pro system,26mm tav evolutpro-26-us,c53269
702945344-4384590-10,i,d,n/a,evolut pro system,26mm tav evolutpro-26-us,c53269
702945344-4384987-10,i,d,189,evolut pro system,29mm tav evolutpro-29-us,c53269
702945344-4386017-10,i,d,226,corevalve evolut r tav,evolutr-34-us,c53269
702945344-4386227-10,i,d,336,evolut pro system,29mm tav evolutpro-29-us,c53269
702945344-4386435-10,i,d,376,evolut pro system,29mm tav evolutpro-29-us,c53269
702945344-4389455-10,i,d,231,evolut pro system,26mm tav evolutpro-26-us,c53269
702945344-4391040-10,i,d,425,corevalve tm evolut tm r transcatheter aortic valve,evolutr-29-us,c53269
702945344-4391127-10,i,d,201,evolut pro system,29mm tav evolutpro-29-us,c53269
702945344-4391335-10,i,d,418,corevalve evolut r tav,evolutr-34-us,c53269
702945344-4391363-10,i,d,264,corevalve evolut r tav,evolutr-34-us,c53269
702945344-4391556-10,i,d,192,evolut pro system,29mm tav evolutpro-29-us,c53269
702945344-4392486-10,i,d,59,corevalve evolut r tav,evolutr-34-us,c53269
702945344-4392973-10,i,d,301,corevalve evolut r tav,evolutr-34-us,c53269
702945344-4393478-10,i,d,349,corevalve tm evolut tm r transcatheter aortic valve,evolutr-26-us,c53269
702945344-4393876-10,i,d,80,corevalve evolut r tav,evolutr-34-us,c53269
702945344-4394024-10,i,d,363,corevalve evolut r tav,evolutr-34-us,c53269
702945344-4394833-10,i,d,248,evolut pro system,26mm tav evolutpro-26-us,c53269
702945344-4395149-10,i,d,243,corevalve system;tav,mcs-p3-29-aoa,c53269
702945344-4396107-10,i,d,83,corevalve tm evolut tm r transcatheter aortic valve,evolutr-26-us,c53269
702945344-4397031-10,i,d,261,evolut pro system,29mm tav evolutpro-29-us,c53269
702945344-4398457-10,i,d,209,enveo tm r delivery catheter system,enveor-us,c53269
702945344-4399942-10,i,d,144,evolut pro system,29mm tav evolutpro-29-us,c53269
702945344-4400728-10,i,d,405,evolut pro system,29mm tav evolutpro-29-us,c53269
702945344-4401590-10,i,d,260,corevalve tm evolut tm r transcatheter aortic valve,evolutr-29-us,c53269
702945344-4402198-10,i,d,57,evolut pro system,26mm tav evolutpro-26-us,c53269
702945344-4404280-10,i,d,98,corevalve tm evolut tm r transcatheter aortic valve,evolutr-29-us,c53269
702945344-4405149-10,i,d,61,corevalve tm evolut tm r transcatheter aortic valve,evolutr-29-us,c53269
702945344-4405391-10,i,d,226,corevalve evolut r tav,evolutr-34-us,c53269
702945344-4405391-10,s,d,,,,
702945344-4405465-10,i,d,131,corevalve tm evolut tm r transcatheter aortic valve,evolutr-29-us,c53269
702945344-4408769-10,i,d,202,corevalve tm evolut tm r transcatheter aortic valve,evolutr-26-us,c53269
702945344-4409643-10,i,d,125,corevalve evolut r tav,evolutr-34-us,c53269
702945344-4409654-10,i,d,303,corevalve system; tav,mcs-p3-29-aoa-us,c53269
702945344-4411744-10,i,d,79,corevalve evolut r tav,evolutr-34-us,c53269
702945344-4412782-10,i,d,76,corevalve tm evolut tm r transcatheter aortic valve,evolutr-29-us,c53269
702945344-4414293-10,i,d,136,corevalve tm evolut tm r transcatheter aortic valve,evolutr-26-us,c53269
702945344-4414886-10,i,d,133,corevalve evolut r tav,evolutr-34-us,c53269
702945344-4415385-10,i,d,8,corevalve tm evolut tm r transcatheter aortic valve,evolutr-29-us,c53269
702945344-4417671-10,i,d,397,corevalve tm evolut tm r transcatheter aortic valve,evolutr-26-us,c53269
702945344-4417700-10,i,d,248,corevalve evolut r tav,evolutr-34-us,c53269
702945344-4418428-10,i,d,72,corevalve system; tav,mcs-p3-26-aoa-us,c53269
702945344-4419064-10,i,d,229,corevalve evolut r tav,evolutr-34-us,c53269
702945344-4419322-10,i,d,275,evolut pro system,29mm tav evolutpro-29-us,c53269
702945344-4420798-10,i,d,276,corevalve evolut r tav,evolutr-34-us,c53269
702945344-4421035-10,i,d,121,corevalve tm evolut tm r transcatheter aortic valve,evolutr-29-us,c53269
702945344-4422159-10,i,d,323,corevalve tm evolut tm r transcatheter aortic valve,evolutr-29-us,c53269
702945344-4422764-10,i,d,371,corevalve evolut r tav,evolutr-34-us,c53269
702945344-4423606-10,i,d,167,corevalve system; tav,mcs-p3-26-aoa-us,c53269
702945344-4424158-10,i,d,261,corevalve evolut r tav,evolutr-34-us,c53269
702945344-4424330-10,i,d,182,corevalve evolut r tav,evolutr-34-us,c53269
702945344-4425949-10,i,d,322,corevalve evolut r tav,evolutr-34-us,c53269
702945344-4425952-10,i,d,374,evolut pro system,29mm tav evolutpro-29-us,c53269
702945344-4429182-10,i,d,n/a,corevalve system; tav,mcs-p3-29-aoa-us,c53269
702945344-4429652-10,i,d,133,corevalve tm evolut tm r transcatheter aortic valve,evolutr-29-us,c53269
702945344-4431086-10,i,d,74,evolut pro system,26mm tav evolutpro-26-us,c53269
702945344-4432569-10,i,d,140,evolut pro system,29mm tav evolutpro-29-us,c53269
702945344-4435188-10,i,d,44,evolut pro system,29mm tav evolutpro-29-us,c53269
702945344-4435877-10,i,d,182,corevalve tm evolut tm r transcatheter aortic valve,evolutr-29-us,c53269
702945344-4436278-10,i,d,228,corevalve evolut r tav,evolutr-34-us,c53269
702945344-4437212-10,i,d,164,corevalve evolut r tav,evolutr-34-us,c53269
702945344-4439006-10,i,d,216,corevalve evolut r tav,evolutr-34-us,c53269
702945344-4440494-10,i,d,242,corevalve tm evolut tm r transcatheter aortic valve,evolutr-29-us,c53269
702945344-4442427-10,i,d,104,evolut pro system,29mm tav evolutpro-29-us,c53269
702945344-4442688-10,i,d,124,evolut pro system,26mm tav evolutpro-26-us,c53269
702945344-4442988-10,i,d,400,corevalve system; tav,mcs-p4-23-aoa-us,c53269
702945344-4443403-10,i,d,222,evolut pro system,29mm tav evolutpro-29-us,c53269
702945344-4444545-10,i,d,266,corevalve system; tav,mcs-p3-29-aoa-us,c53269
702945344-4447223-10,i,d,190,corevalve evolut r tav,evolutr-34-us,c53269
702945344-4448139-10,i,d,262,corevalve tm evolut tm r transcatheter aortic valve,evolutr-26-us,c53269
702945344-4450953-10,i,d,333,evolut pro system,29mm tav evolutpro-29-us,c53269
702945344-4451348-10,i,d,89,corevalve tm evolut tm r transcatheter aortic valve,evolutr-29-us,c53269
702945344-4451656-10,i,d,n/a,corevalve evolut r tav,evolutr-34-us,c53269
702945344-4451656-10,s,d,,,,
702945344-4451814-10,i,d,260,corevalve tm evolut tm r transcatheter aortic valve,evolutr-29-us,c53269
702945344-4454356-10,i,d,347,evolut pro system,29mm tav evolutpro-29-us,c53269
702945344-4455054-10,i,d,285,evolut pro system,29mm tav evolutpro-29-us,c53269
702945344-4455678-10,i,d,392,corevalve system; tav,mcs-p3-26-aoa-us,c53269
702945344-4455932-10,i,d,282,corevalve evolut r tav,evolutr-34-us,c53269
702945344-4457612-10,i,d,n/a,evolut pro system,26mm tav evolutpro-26-us,c53269
702945344-4458141-10,i,d,96,corevalve tm evolut tm r transcatheter aortic valve,evolutr-26-us,c53269
702945344-4458915-10,i,d,n/a,corevalve tm evolut tm r transcatheter aortic valve,evolutr-29-us,c53269
702945344-4459480-10,i,d,114,evolut pro system,26mm tav evolutpro-26-us,c53269
702945344-4459911-10,i,d,340,evolut pro system,23mm tav evolutpro-23-us,c53269
702945344-4463380-10,i,d,265,corevalve tm evolut tm r transcatheter aortic valve,evolutr-26-us,c53269
702945344-4464038-10,i,d,317,corevalve system; tav,mcs-p3-29-aoa-us,c53269
702945344-4464295-10,i,d,242,corevalve evolut r tav,evolutr-34-us,c53269
702945344-4464316-10,i,d,193,enveo tm r loading system,ls-enveor2629us,c53269
702945344-4465724-10,i,d,227,corevalve tm evolut tm r transcatheter aortic valve,evolutr-29-us,c53269
702945344-4465873-10,i,d,145,evolut pro system,26mm tav evolutpro-26-us,c53269
702945344-4467574-10,i,d,91,evolut pro system,29mm tav evolutpro-29-us,c53269
702945344-4468512-10,i,d,176,corevalve system; tav,mcs-p3-29-aoa-us,c53269
702945344-4468812-10,i,d,55,evolut pro system,29mm tav evolutpro-29-us,c53269
702945344-4469031-10,i,d,42,evolut pro system,29mm tav evolutpro-29-us,c53269
702945344-4471097-10,i,d,2,corevalve tm evolut tm r transcatheter aortic valve,evolutr-29-us,c53269
702945344-4472389-10,i,d,n/a,corevalve evolut r tav,evolutr-34-us,c53269
702945344-4472728-10,i,d,200,evolut pro system,26mm tav evolutpro-26-us,c53269
702945344-4474898-10,i,d,307,corevalve evolut r tav,evolutr-34-us,c53269
702945344-4475202-10,i,d,63,corevalve tm evolut tm r transcatheter aortic valve,evolutr-29-us,c53269
702945344-4475469-10,i,d,307,corevalve tm evolut tm r transcatheter aortic valve,evolutr-29-us,c53269
702945344-4476593-10,i,d,159,corevalve tm evolut tm r transcatheter aortic valve,evolutr-23-us,c53269
702945344-4476797-10,i,d,233,evolut pro system,26mm tav evolutpro-26-us,c53269
702945344-4477336-10,i,d,n/a,corevalve evolut r tav,evolutr-34-us,c53269
702945344-4478365-10,i,d,255,corevalve evolut r tav,evolutr-34-us,c53269
702945344-4478802-10,i,d,332,corevalve evolut r tav,evolutr-34-us,c53269
702945344-4482454-10,i,d,117,corevalve tm evolut tm r transcatheter aortic valve,evolutr-29-us,c53269
702945344-4482894-10,i,d,299,evolut pro system,29mm tav evolutpro-29-us,c53269
702945344-4484245-10,i,d,130,corevalve evolut r tav,evolutr-34-us,c53269
702945344-4484331-10,i,d,336,evolut pro system,29mm tav evolutpro-29-us,c53269
702945344-4485042-10,i,d,350,corevalve tm evolut tm r transcatheter aortic valve,evolutr-29-us,c53269
702945344-4487957-10,i,d,72,evolut pro system,29mm tav evolutpro-29-us,c53269
702945344-4488027-10,i,d,239,corevalve evolut r tav,evolutr-34-us,c53269
702945344-4489026-10,i,d,98,corevalve evolut r tav,evolutr-34-us,c53269
702945344-4489448-10,i,d,145,corevalve tm evolut tm r transcatheter aortic valve,evolutr-26-us,c53269
702945344-4490269-10,i,d,178,evolut pro system,29mm tav evolutpro-29-us,c53269
702945344-4490279-10,i,d,133,evolut pro system,29mm tav evolutpro-29-us,c53269
702945344-4490410-10,i,d,210,corevalve tm evolut tm r transcatheter aortic valve,evolutr-29-us,c53269
702945344-4490606-10,i,d,105,corevalve tm evolut tm r transcatheter aortic valve,evolutr-26-us,c53269
702945344-4492279-10,i,d,284,evolut pro system,23mm tav evolutpro-23-us,c53269
702945344-4492358-10,i,d,112,corevalve evolut r tav,evolutr-34-us,c53269
702945344-4493582-10,i,d,23,corevalve evolut r tav,evolutr-34-us,c53269
702945344-4493582-10,s,d,,,,
702945344-4494034-10,i,d,265,evolut pro system,26mm tav evolutpro-26-us,c53269
702945344-4497071-10,i,d,158,corevalve tm evolut tm r transcatheter aortic valve,evolutr-29-us,c53269
702945344-4499222-10,i,d,268,evolut pro system,26mm tav evolutpro-26-us,c53269
702945344-4499786-10,i,d,301,evolut pro system,29mm tav evolutpro-29-us,c53269
702945344-4518344-10,i,d,164,evolut pro system,29mm tav evolutpro-29-us,c53269
702945344-4518456-10,i,d,271,corevalve evolut r tav,evolutr-34-us,c53269
702945344-4518475-10,i,d,90,corevalve evolut r tav,evolutr-34-us,c53269
702945344-4518761-10,i,d,238,evolut pro system,29mm tav evolutpro-29-us,c53269
702945344-4520187-10,i,d,113,corevalve tm evolut tm r transcatheter aortic valve,evolutr-29-us,c53269
702945344-4521568-10,i,d,315,corevalve tm evolut tm r transcatheter aortic valve,evolutr-26-us,c53269
702945344-4522290-10,i,d,104,corevalve tm evolut tm r transcatheter aortic valve,evolutr-26-us,c53269
702945344-4524013-10,i,d,329,corevalve tm evolut tm r transcatheter aortic valve,evolutr-26-us,c53269
702945344-4525760-10,i,d,287,evolut pro system,26mm tav evolutpro-26-us,c53269
702945344-4526829-10,i,d,115,corevalve tm evolut tm r transcatheter aortic valve,evolutr-29-us,c53269
702945344-4529594-10,i,d,305,corevalve system; tav,mcs-p3-26-aoa-us,c53269
702945344-4530153-10,i,d,248,corevalve evolut r tav,evolutr-34-us,c53269
702945344-4530625-10,i,d,236,corevalve evolut r tav,evolutr-34-us,c53269
702945344-4535890-10,i,d,104,corevalve evolut r tav,evolutr-34-us,c53269
702945344-4537006-10,i,d,175,evolut pro system,29mm tav evolutpro-29-us,c53269
702945344-4553956-10,i,d,183,corevalve evolut r tav,evolutr-34-us,c53269
702945344-4557437-10,i,d,2,corevalve tm evolut tm r transcatheter aortic valve,evolutr-26-us,c53269
702945344-4557445-10,i,d,114,evolut pro system,26mm tav evolutpro-26-us,c53269
702945344-4557540-10,i,d,237,corevalve evolut r tav,evolutr-34-us,c53269
702945344-4562106-10,i,d,80,enveo tm r loading system,ls-enveor2629us,c53269
702945344-4574399-10,i,d,154,corevalve evolut r tav,evolutr-34-us,c53269
702945344-4576469-10,i,d,256,corevalve tm evolut tm r transcatheter aortic valve,evolutr-26-us,c53269
702945344-4577572-10,i,d,165,corevalve tm evolut tm r transcatheter aortic valve,evolutr-23-us,c53269
702945344-4578307-10,i,d,216,evolut pro system,26mm tav evolutpro-26-us,c53269
702945344-4582204-10,i,d,212,corevalve tm evolut tm r transcatheter aortic valve,evolutr-23-us,c53269
702945344-4604662-10,i,d,389,evolut pro system,29mm tav evolutpro-29-us,c53269
702945344-4605336-10,i,d,145,evolut pro system,29mm tav evolutpro-29-us,c53269
702945344-4608444-10,i,d,262,evolut pro system,29mm tav evolutpro-29-us,c53269
702945344-4609644-10,i,d,154,corevalve evolut r tav,evolutr-34-us,c53269
702945344-4609686-10,i,d,253,corevalve tm evolut tm r transcatheter aortic valve,evolutr-29-us,c53269
702945344-4610565-10,i,d,203,corevalve evolut r tav,evolutr-34-us,c53269
702945344-4614187-10,i,d,158,corevalve evolut r tav,evolutr-34-us,c53269
702945344-4616243-10,i,d,99,evolut pro system,29mm tav evolutpro-29-us,c53269
702945344-4617384-10,i,d,296,evolut pro system,29mm tav evolutpro-29-us,c53269
702945344-4617796-10,i,d,246,corevalve tm evolut tm r transcatheter aortic valve,evolutr-23-us,c53269
702945344-4620923-10,i,d,282,evolut pro system,26mm tav evolutpro-26-us,c53269
702945344-4623179-10,i,d,234,evolut pro system,29mm tav evolutpro-29-us,c53269
702945344-4625204-10,i,d,248,evolut pro system,29mm tav evolutpro-29-us,c53269
702945344-4625390-10,i,d,223,corevalve evolut r tav,evolutr-34-us,c53269
702945344-4627074-10,i,d,40,evolut pro system,29mm tav evolutpro-29-us,c53269
702945344-4628086-10,i,d,296,corevalve tm evolut tm r transcatheter aortic valve,evolutr-29-us,c53269
702945344-4628127-10,i,d,6,corevalve evolut r tav,evolutr-34-us,c53269
702945344-4630021-10,i,d,205,corevalve tm evolut tm r transcatheter aortic valve,evolutr-29-us,c53269
702945344-4630469-10,i,d,317,corevalve evolut r tav,evolutr-34-us,c53269
702945344-4632566-10,i,d,319,evolut pro system,29mm tav evolutpro-29-us,c53269
702945344-4632925-10,i,d,205,corevalve tm evolut tm r transcatheter aortic valve,evolutr-29-us,c53269
702945344-4633796-10,i,d,296,evolut pro system,29mm tav evolutpro-29-us,c53269
702945344-4634344-10,i,d,274,corevalve evolut r tav,evolutr-34-us,c53269
702945344-4636683-10,i,d,164,corevalve evolut r tav,evolutr-34-us,c53269
702945344-4636948-10,i,d,n/a,corevalve tm evolut tm r transcatheter aortic valve,evolutr-26-us,c53269
702945344-4639244-10,i,d,182,evolut pro system,29mm tav evolutpro-29-us,c53269
702945344-4641351-10,i,d,181,corevalve evolut r tav,evolutr-34-us,c53269
702945344-4641734-10,i,d,0,evolut pro system,26mm tav evolutpro-26-us,c53269
702945344-4642515-10,i,d,238,evolut pro system,29mm tav evolutpro-29-us,c53269
702945344-4647226-10,i,d,84,evolut pro system,26mm tav evolutpro-26-us,c53269
702945344-4667505-10,i,d,78,evolut pro system,29mm tav evolutpro-29-us,c53269
702945344-4677602-10,i,d,290,evolut pro system,29mm tav evolutpro-29-us,c53269
702945344-4695198-10,i,d,84,corevalve tm evolut tm r transcatheter aortic valve,evolutr-29-us,c53269
702945344-4695286-10,i,d,0,evolut pro system,26mm tav evolutpro-26-us,c53269
702945344-4699705-10,i,d,288,corevalve evolut r tav,evolutr-34-us,c53269
702945344-4699705-10,s,d,,,,
702945344-4702557-10,i,d,22,corevalve evolut r tav,evolutr-34-us,c53269
702945344-4708148-10,i,d,323,corevalve tm evolut tm r transcatheter aortic valve,evolutr-29-us,c53269
702945344-4718923-10,i,d,194,corevalve evolut r tav,evolutr-34-us,c53269
702945344-4719146-10,i,d,98,corevalve tm evolut tm r transcatheter aortic valve,evolutr-26-us,c53269
702945344-4721532-10,i,d,82,corevalve evolut r tav,evolutr-34-us,c53269
702945344-4722088-10,i,d,177,corevalve evolut r tav,evolutr-34-us,c53269
702945344-4723633-10,i,d,131,enveo tm r loading system,ls-enveor23us,c53269
702945344-4725748-10,i,d,0,evolut pro system,23mm tav evolutpro-23-us,c53269
702945344-4730200-10,i,d,125,evolut pro system,26mm tav evolutpro-26-us,c53269
702945344-4730627-10,i,d,169,corevalve tm evolut tm r transcatheter aortic valve,evolutr-26-us,c53269
702945344-4733064-10,i,d,151,corevalve evolut r tav,evolutr-34-us,c53269
702945344-4738595-10,i,d,85,evolut pro system,29mm tav evolutpro-29-us,c53269
702945344-4739856-10,i,d,123,corevalve evolut r tav,evolutr-34-us,c53269
702945344-4761786-10,i,d,37,evolut pro system,29mm tav evolutpro-29-us,c53269;c62917
702945344-4761909-10,i,d,214,evolut pro system,29mm tav evolutpro-29-us,c53269
702945344-4765980-10,i,d,204,corevalve evolut r tav,evolutr-34-us,c53269
702945344-4769738-10,i,d,n/a,corevalve tm evolut tm r transcatheter aortic valve,evolutr-26-us,c53269
702945344-4797812-10,i,d,13,evolut pro system,26mm tav evolutpro-26-us,c53269
702945344-4802802-10,i,d,18,evolut pro system,26mm tav evolutpro-26-us,c53269
702945344-4804633-10,i,d,39,corevalve evolut r tav,evolutr-34-us,c53269
702945344-4808385-10,i,d,8,corevalve tm evolut tm r transcatheter aortic valve,evolutr-23-us,c53269;c(update)
702945344-4818599-10,i,d,45,corevalve evolut r tav,evolutr-34-us,c53269
702945344-4829076-10,i,d,4,evolut pro system,29mm tav evolutpro-29-us,c53269
702945344-4830086-10,i,d,57,corevalve tm evolut tm r transcatheter aortic valve,evolutr-23-us,c53269
702945344-4844077-10,i,d,108,evolut pro system,26mm tav evolutpro-26-us,c53269
702945344-4848506-10,i,d,81,corevalve evolut r tav,evolutr-34-us,c53269
702945344-4849697-10,i,d,75,corevalve evolut r tav,evolutr-34-us,c53269
702945344-4859929-10,i,d,41,evolut pro system,23mm tav evolutpro-23-us,c53269
702945344-4861905-10,i,d,135,corevalve tm evolut tm r transcatheter aortic valve,evolutr-29-us,c53269
702945344-4861905-10,s,d,,,,
702945344-4864488-10,i,d,54,corevalve evolut r tav,evolutr-34-us,c53269
702945344-4865606-10,i,d,23,corevalve tm evolut tm r transcatheter aortic valve,evolutr-29-us,c53269
702945344-4866127-10,i,d,23,evolut pro system,29mm tav evolutpro-29-us,c53269
702945344-4868308-10,i,d,40,corevalve tm evolut tm r transcatheter aortic valve,evolutr-23-us,c53269
702945344-4873381-10,i,d,65,corevalve evolut r tav,evolutr-34-us,c53269
702945344-4873502-10,i,d,50,evolut pro system,29mm tav evolutpro-29-us,c53269
702945344-4875632-10,i,d,18,corevalve tm evolut tm r transcatheter aortic valve,evolutr-23-us,c53269
702945344-4876082-10,i,d,72,evolut pro system,29mm tav evolutpro-29-us,c53269
702945344-4878454-10,i,d,43,evolut pro system,29mm tav evolutpro-29-us,c53269
702945344-4878618-10,i,d,78,corevalve tm evolut tm r transcatheter aortic valve,evolutr-29-us,c53269
702945344-4878710-10,i,d,6,evolut pro system,29mm tav evolutpro-29-us,c53269
702945344-4882696-10,i,d,90,corevalve evolut r tav,evolutr-34-us,c53269
702945344-4884335-10,i,d,53,corevalve tm evolut tm r transcatheter aortic valve,evolutr-26-us,c53269
702945344-4907473-10,i,d,27,corevalve evolut r tav,evolutr-34-us,c53269
702945344-4909116-10,i,d,97,corevalve tm evolut tm r transcatheter aortic valve,evolutr-23-us,c53269
702945344-4915448-10,i,d,13,corevalve system; tav,mcs-p3-26-aoa-us,c53269
702945344-4916225-10,i,d,29,evolut pro system,29mm tav evolutpro-29-us,c53269
702945344-4918396-10,i,d,19,corevalve tm evolut tm r transcatheter aortic valve,evolutr-23-us,c53269
702945344-4920685-10,i,d,n/a,evolut pro system,26mm tav evolutpro-26-us,c53269
702945344-4920685-10,s,d,,,,
702945344-4923776-10,i,d,17,corevalve evolut r tav,evolutr-34-us,c53269
702945344-4928832-10,i,d,69,corevalve evolut r tav,evolutr-34-us,c53269
702945344-4929378-10,i,d,4,corevalve evolut r tav,evolutr-34-us,c53269
702945344-4929638-10,i,d,0,evolut pro system,29mm tav evolutpro-29-us,c53269;c76126
702945344-4930047-10,i,d,0,evolut pro system,26mm tav evolutpro-26-us,c53269
702945344-4930556-10,i,d,45,corevalve tm evolut tm r transcatheter aortic valve,evolutr-26-us,c53269
702945344-4930646-10,i,d,0,evolut pro system,26mm tav evolutpro-26-us,c53269
702945344-4931026-10,i,d,0,evolut pro system,26mm tav evolutpro-26-us,c53269
702945344-4931110-10,i,d,16,enveo tm r loading system,ls-enveor2629us,c53269
702945344-4932846-10,i,d,42,corevalve evolut r tav,evolutr-34-us,c53269
702945344-4933570-10,i,d,0,evolut pro system,29mm tav evolutpro-29-us,c53269
702945344-4934224-10,i,d,81,corevalve tm evolut tm r transcatheter aortic valve,evolutr-26-us,c53269
702945344-4934600-10,i,d,14,corevalve tm evolut tm r transcatheter aortic valve,evolutr-29-us,c53269
702945344-4946493-10,i,d,56,evolut pro system,26mm tav evolutpro-26-us,c53269
702945344-4946493-10,s,d,,,,
702945344-4946641-10,i,d,25,evolut pro system,29mm tav evolutpro-29-us,c53269
702945344-4947397-10,i,d,10,evolut pro system,29mm tav evolutpro-29-us,c53269
702945344-4947427-10,i,d,16,evolut pro system,29mm tav evolutpro-29-us,c53269
702945344-4947626-10,i,d,0,evolut pro system,26mm tav evolutpro-26-us,c53269
702945344-4949179-10,i,d,67,corevalve evolut r tav,evolutr-34-us,c53269
702945344-4950395-10,i,d,0,evolut pro system,29mm tav evolutpro-29-us,c53269
702945344-4951313-10,i,d,21,corevalve evolut r tav,evolutr-34-us,c53269
702945344-4952582-10,i,d,74,corevalve tm evolut tm r transcatheter aortic valve,evolutr-29-us,c53269
702945344-4953007-10,i,d,27,evolut pro system,26mm tav evolutpro-26-us,c53269
702945344-4953111-10,i,d,25,evolut pro system,29mm tav evolutpro-29-us,c53269
702945344-4953568-10,i,d,8,evolut pro system,29mm tav evolutpro-29-us,c53269
702945344-4955663-10,i,d,1,corevalve evolut r tav,evolutr-34-us,c53269
702945344-4956229-10,i,d,20,corevalve evolut r tav,evolutr-34-us,c53269
702945344-4956894-10,i,d,26,corevalve tm evolut tm r transcatheter aortic valve,evolutr-26-us,c53269
702945344-4957111-10,i,d,41,corevalve tm evolut tm r transcatheter aortic valve,evolutr-29-us,c53269
702945344-4959837-10,i,d,5,corevalve tm evolut tm r transcatheter aortic valve,evolutr-23-us,c53269
702945344-4962238-10,i,d,0,corevalve system; tav,mcs-p3-29-aoa-us,c53269
702945344-4962610-10,i,d,33,evolut pro system,29mm tav evolutpro-29-us,c62814
702945344-4964980-10,i,d,0,corevalve tm evolut tm r transcatheter aortic valve,evolutr-29-us,c53269
702945344-4966412-10,i,d,0,corevalve tm evolut tm r transcatheter aortic valve,evolutr-26-us,c53269;c62814
702945344-4966510-10,i,d,57,evolut pro system,29mm tav evolutpro-29-us,c53269
702945344-4967176-10,i,d,5,evolut pro system,29mm tav evolutpro-29-us,c53269
702945344-4967934-10,i,d,29,enveo tm r loading system,ls-enveor2629us,c53269
702945344-4969013-10,i,d,1,corevalve tm evolut tm r transcatheter aortic valve,evolutr-29-us,c53269
702945344-4969131-10,i,d,0,corevalve tm evolut tm r transcatheter aortic valve,evolutr-23-us,c53269
702945344-4970472-10,i,d,0,evolut pro system,26mm tav evolutpro-26-us,c53269
702945344-4970472-10,s,d,,,,
702945344-4972306-10,i,d,45,evolut pro system,26mm tav evolutpro-26-us,c53269
702945344-4973327-10,i,d,0,evolut pro system,26mm tav evolutpro-26-us,c53269
702945344-4973327-10,s,d,,,,
702945344-4973552-10,i,d,3,evolut pro system,29mm tav evolutpro-29-us,c53269
702945344-4974592-10,i,d,5,evolut pro system,29mm tav evolutpro-29-us,c53269
702945344-4974710-10,i,d,0,enveo tm r loading system,ls-enveor23us,c53269
702945344-4974710-10,s,d,,,,
702945344-4976159-10,i,d,4,evolut pro system,29mm tav evolutpro-29-us,c53269
702945344-4977094-10,i,d,13,evolut pro system,29mm tav evolutpro-29-us,c53269
702945344-4977348-10,i,d,5,evolut pro system,29mm tav evolutpro-29-us,c53269
702945344-4977355-10,i,d,8,corevalve tm evolut tm r transcatheter aortic valve,evolutr-26-us,c53269
702945344-4977364-10,i,d,9,corevalve evolut r tav,evolutr-34-us,c53269
702945344-4977389-10,i,d,49,evolut pro system,26mm tav evolutpro-26-us,c53269
702945344-4978030-10,i,d,27,evolut pro system,29mm tav evolutpro-29-us,c53269
702945344-4978246-10,i,d,21,evolut pro system,26mm tav evolutpro-26-us,c53269
702945344-4979602-10,i,d,24,corevalve system; tav,mcs-p4-23-aoa-us,c53269
702945344-4979612-10,i,d,0,corevalve tm evolut tm r transcatheter aortic valve,evolutr-23-us,c53269
702945344-4979895-10,i,d,24,corevalve system; tav,mcs-p3-26-aoa-us,c53269
702945344-4980652-10,i,d,2,corevalve evolut r tav,evolutr-34-us,c53269
702945344-4981159-10,i,d,1,evolut pro system,26mm tav evolutpro-26-us,c53269; c62917
702945344-4982727-10,i,d,2,corevalve system; tav,mcs-p3-26-aoa-us,c53269
702945344-4984935-10,i,d,15,evolut pro system,29mm tav evolutpro-29-us,c53269
702945344-4987165-10,i,d,5,evolut pro system,26mm tav evolutpro-26-us,c53269
702945344-4987338-10,i,d,11,corevalve evolut r tav,evolutr-34-us,c53269
702945344-4988310-10,i,d,47,evolut pro system,26mm tav evolutpro-26-us,c53269
702945344-4988423-10,i,d,23,evolut pro system,29mm tav evolutpro-29-us,c53269
702945344-4988475-10,i,d,0,corevalve tm evolut tm r transcatheter aortic valve,evolutr-29-us,c53269
702945344-4989165-10,i,d,11,corevalve evolut r tav,evolutr-34-us,c53269
702945344-4989284-10,i,d,28,corevalve evolut r tav,evolutr-34-us,c53269
702945344-4990304-10,i,d,7,corevalve tm evolut tm r transcatheter aortic valve,evolutr-29-us,c53269
702945344-4991389-10,i,d,0,evolut pro system,29mm tav evolutpro-29-us,c53269
702945344-4991407-10,i,d,69,evolut pro system,29mm tav evolutpro-29-us,c53269
702945344-4991777-10,i,d,14,evolut pro system,26mm tav evolutpro-26-us,c53269
702945344-4991777-10,s,d,,,,
702945344-4991992-10,i,d,0,evolut pro system,26mm tav evolutpro-26-us,c53269
702945344-4992131-10,i,d,0,evolut pro system,26mm tav evolutpro-26-us,c53269
702945344-4992477-10,i,d,30,evolut pro system,23mm tav evolutpro-23-us,c53269
702945344-4992516-10,i,d,70,corevalve evolut r tav,evolutr-34-us,c53269
702945344-4992952-10,i,d,6,evolut pro system,29mm tav evolutpro-29-us,c53269
702945344-5003917-10,i,d,8,corevalve tm evolut tm r transcatheter aortic valve,evolutr-23-us,c53269
702945344-5004325-10,i,d,0,evolut pro system,26mm tav evolutpro-26-us,c53269
702945344-5004408-10,i,d,47,evolut pro system,29mm tav evolutpro-29-us,c53269
702945344-5005734-10,i,d,0,evolut pro system,23mm tav evolutpro-23-us,c53269
702945344-5007475-10,i,d,33,evolut pro system,26mm tav evolutpro-26-us,c53269
702945344-5008037-10,i,d,5,corevalve evolut r tav,evolutr-34-us,c53269
702945344-5008179-10,i,d,20,corevalve evolut r tav,evolutr-34-us,c53269
702945344-5008179-10,s,d,,,,
702945344-5008987-10,i,d,0,evolut pro system,26mm tav evolutpro-26-us,c53269;c62814
702945344-5009686-10,i,d,9,evolut pro system,26mm tav evolutpro-26-us,c53269;c76126
702945344-5009786-10,i,d,5,corevalve tm evolut tm r transcatheter aortic valve,evolutr-26-us,c53269
702945344-5010514-10,i,d,22,evolut pro system,29mm tav evolutpro-29-us,c53269
702945344-5010587-10,i,d,54,evolut pro system,29mm tav evolutpro-29-us,c53269
702945344-5010883-10,i,d,0,evolut pro system,29mm tav evolutpro-29-us,c53269
702945344-5011429-10,i,d,18,evolut pro system,29mm tav evolutpro-29-us,c53269
702945344-5012980-10,i,d,0,corevalve tm evolut tm r transcatheter aortic valve,evolutr-29-us,c53269
702945344-5012980-10,s,d,,,,
702945344-5013291-10,i,d,6,corevalve tm evolut tm r transcatheter aortic valve,evolutr-26-us,c53269
702945344-5014502-10,i,d,26,evolut pro system,29mm tav evolutpro-29-us,c53269
702945344-5015303-10,i,d,93,corevalve evolut r tav,evolutr-34-us,c53269
702945344-5015360-10,i,d,26,corevalve evolut r tav,evolutr-34-us,c53269
702945344-5016754-10,i,d,0,evolut pro system,29mm tav evolutpro-29-us,c53269
702945344-5017948-10,i,d,3,evolut pro system,29mm tav evolutpro-29-us,c53269
702945344-5018302-10,i,d,5,corevalve evolut r tav,evolutr-34-us,c53269
702945344-5018877-10,i,d,140,corevalve evolut r tav,evolutr-34-us,c53269
702945344-5019013-10,i,d,24,corevalve tm evolut tm r transcatheter aortic valve,evolutr-23-us,c53269
702945344-5019113-10,i,d,0,evolut pro system,29mm tav evolutpro-29-us,c53269
702945344-5019162-10,i,d,21,corevalve tm evolut tm r transcatheter aortic valve,evolutr-26-us,c53269
702945344-5019449-10,i,d,9,evolut pro system,29mm tav evolutpro-29-us,c53269
702945344-5019451-10,i,d,1,evolut pro system,26mm tav evolutpro-26-us,c53269
702945344-5019694-10,i,d,54,evolut pro system,29mm tav evolutpro-29-us,c53269
702945344-5019966-10,i,d,43,corevalve tm evolut tm r transcatheter aortic valve,evolutr-29-us,c53269
702945344-5021825-10,i,d,0,corevalve evolut r tav,evolutr-34-us,c53269
702945344-5022648-10,i,d,4,corevalve tm evolut tm r transcatheter aortic valve,evolutr-29-us,c53269
702945344-5023973-10,i,d,12,corevalve evolut r tav,evolutr-34-us,c53269
702945344-5035737-10,i,d,18,corevalve tm evolut tm r transcatheter aortic valve,evolutr-26-us,c53269
702945344-5035783-10,i,d,1,corevalve evolut r tav,evolutr-34-us,c53269
702945344-5036616-10,i,d,0,corevalve tm evolut tm r transcatheter aortic valve,evolutr-29-us,c53269
702945344-5044431-10,i,d,13,corevalve evolut r tav,evolutr-34-us,c53269
702945344-5046941-10,i,d,5,corevalve evolut r tav,evolutr-34-us,c53269
702945344-5047053-10,i,d,0,evolut pro system,29mm tav evolutpro-29-us,c53269
702945344-5048107-10,i,d,100,corevalve tm evolut tm r transcatheter aortic valve,evolutr-23-us,c53269
702945344-5049372-10,i,d,11,evolut pro system,29mm tav evolutpro-29-us,c53269
702945344-5049419-10,i,d,15,corevalve evolut r tav,evolutr-34-us,c53269
702945344-5052356-10,i,d,42,corevalve tm evolut tm r transcatheter aortic valve,evolutr-29-us,c53269
702945344-5052554-10,i,d,4,evolut pro system,26mm tav evolutpro-26-us,c53269
702945344-5054557-10,i,d,26,corevalve tm evolut tm r transcatheter aortic valve,evolutr-29-us,c53269
702945344-5054911-10,i,d,10,corevalve evolut r tav,evolutr-34-us,c53269
702945344-5066408-10,i,d,2,evolut pro system,29mm tav evolutpro-29-us,c53269
702945344-5066722-10,i,d,1,corevalve evolut r tav,evolutr-34-us,c53269
702945344-5071161-10,i,d,34,corevalve system; tav,mcs-p3-26-aoa-us,c53269.

• Brand Name: COREVALVE TRANSCATHETER AORTIC VALVE
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 8227700
• MDR Text Key: 132408423
• Report Number: 2025587-2019-00107
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• PMA/PMN Number: P130021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CRS
• Device Catalogue Number: CRS
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/05/2018
• Initial Date FDA Received: 01/08/2019
• Supplement Dates Manufacturer Received: 02/04/2019; 05/08/2019; 08/13/2019; 11/05/2019; 11/05/2019; 06/02/2020; 11/09/2020; 11/09/2020; 11/09/2020
• Supplement Dates FDA Received: 04/11/2019; 07/30/2019; 11/11/2019; 01/27/2020; 04/30/2020; 07/28/2020; 01/27/2021; 05/03/2021; 07/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Life Threatening; Required Intervention
• Patient Age: 79 YR