MEDTRONIC HEART VALVES DIVISION ENVEO PRO DELIVERY SYSTEM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
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Model Number ENVPRO-16 |
Device Problems
Failure to Advance (2524); Patient Device Interaction Problem (4001)
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Patient Problem
Rupture (2208)
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Event Date 12/29/2023 |
Event Type
Injury
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Event Description
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Medtronic received information that during the implant of this transcatheter bioprosthetic valve, the delivery catheter system (dcs) was unable to be advanced through the right femoral artery access site after several attempts.It was reported that the accesses did not have significant calcification and/or tortuosity.The physician believed that when they began to advance, the artery was invaginated or perhaps dragged part of the artery's intima, impeding the delivery progress.It was further reported that a rupture of the right common femoral artery wall had occurred, which required surgical repair with a polytetrafluoroethylene (ptfe) patch.Then the implanting physicians switched to left femoral access and used a new dcs.Six days after the procedure, the patient was discharged without complications.No additional adverse patient effects were reported.
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Manufacturer Narrative
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Continuation of d10: product id: unknown evolutpro-23; product type: heart valves; implant date: (b)(6) 2023.Medtronic has requested additional information pertaining to this reportable event.If additional reportable information is received, a supplemental report will be submitted.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.
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Event Description
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Additional information was received that the introducer sheath used was not a medtronic device.
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Manufacturer Narrative
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Event description continuation of d10: product id: unknown 22 mm introducer sheath; product lot/serial number: unknown; product type: introducer sheath; 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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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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Event Description
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Additional information was received indicating that the delivery catheter system (dcs) was not believe to have caused the rupture because the diameters of the arteries were sufficient for the catheter.The injury was attributed to the introducer sheath that was attempted before inserting the dcs.It was noted that a 22 fr (french) introducer sheath was used because they did not have a 20 fr introducer sheath.
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Search Alerts/Recalls
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