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MEDTRONIC HEART VALVES DIVISION EVOLUT PRO PLUS DCS; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
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| Model Number D-EVPROP2329US |
| Device Problems
Failure to Advance (2524); Patient Device Interaction Problem (4001)
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| Patient Problems
Disseminated Intravascular Coagulation (DIC) (1813); Vascular Dissection (3160); Multiple Organ Failure (3261); Pericardial Effusion (3271)
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| Event Date 03/16/2023 |
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Event Type
Death
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Event Description
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Medtronic received information that during implant of this transcatheter bioprosthetic valve, strong tortuosity was observed in this patient's abdominal aorta, and an attempt was made to advance the delivery catheter system (dcs) using a non-medtronic lunderquist main wire, however it could not advance.The dcs was withdrawn and replaced.A snare was used to advance the replacement dcs into the lumen, and then second attempt was made to advance, however the "torque could not be transmitted" as a result of the tortuosity.During that time, the patient's blood pressure decreased.A pericardial effusion was noted, therefore a pericardial puncture was performed and the procedure was transitioned to a thoracotomy.A thoracic aortic dissection was observed via contrast study.The 18 fr sheath was exchanged for a 22 fr sheath, and 2 thoracic endovascular aortic repair (tevar) stents were placed.A non-medtronic (edwards) s3 valve was placed over the 22 fr sheath, however when the 22 fr sheath was inserted, the blood vessel was damaged.Further surgical treatment and stents were placed.No additional adverse patient effects were reported.
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Manufacturer Narrative
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Concomitant medical products: other relevant device(s) are: product id: d-evprop2329us, serial/lot #: (b)(4), ubd: 27-jun-2024, udi#: (b)(4) product analysis: no product was returned.Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.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 which reported that both dcs systems could not advance past the top of the patient's aortic arch.It was reported that the thoracotomy was performed first due to the pericardial effusion.The thoracic aortic dissection was observed in angiography, which was performed following completion of the thoracotomy, followed by stent graft placement and finally, followed by the placement//implantation of the non-medtronic s3 transcatheter valve.It was reported that the likely cause of the thoracic aortic dissection was the interaction of the "landakist" and dcs with the calcification of the tortuous region during attempted advancement.It was reported that the patient died two days following the valve implant from multi organ failure due to "dic".According to the physician, it was possible that the thoracotomy and femoral vascular repair may have had an effect on the patient death.Of note, the vascular ruptured during insertion of the 22fr non-medtronic (dryseal) sheath used for stent graft placement.
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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 that the cause of the pericardial effusion was not determined but it occurred prior to surgery.A left ventricular perforation from the non-medtronic guidewire (lunderquist) was suspected but it was confirmed after the thoracotomy that no perforation occurred.It was reported the difficulty advancing the dcs may have contributed to the need for thoracotomy.The likely cause of the thoracic aortic dissection was the interaction of the non-medtronic guidewire and dcs with the calcification of the tortuous region during attempted advancement.The patient¿s death from multiple organ failure was due to disseminated intravascular coagulation (dic).
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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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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.Difficulties advancing the delivery catheter system (dcs) through the vessel is known to be related to factors such as patient anatomy and physician technique, including guidewire and introducer sheath selection.In this case, it was noted that there was strong tortuosity of the abdominal aorta.This indicates that the probable cause of the advancement difficulties was patient anatomy, but this cannot be confirmed with the limited information available.Vascular access related complications, such as aortic dissection, effusion, and patient death, are a known potential adverse patient effect per the device instructions for use (ifu), and are typically related to patient factors (anatomy, comorbidities, etc.), and/or procedural effects (sheath used, user technique, puncture cut location, etc.).It was reported that the difficulty advancing the dcs may have contributed to the need for thoracotomy.The likely cause of the thoracic aortic dissection was the interaction of the non-medtronic guidewire and dcs with the calcification of the tortuous region during attempted advancement.There was no information to suggest a device malfunction or a failure to meet manufacturing specifications was related to these events.Upon review of the information provided, the primary event of thoracic aortic dissection leading to pericardial effusion, pericardiocentesis and surgical repair is assessed as likely related to the evolut pro+ dcs in combination with the non-medtronic lunderquist wire.A contributing factor was the patient¿s anatomy, including severe calcium and tortuosity of the aorta/aortic arch through which the pro+ dcs was unable to advance.Aortic dissection and unplanned intervention are known potential risks associated with the implantation of the evolut pro+ valve and all reported adverse events and severities are documented in our risk files and ifu.No further safety assessment is required at this time.Updated: h6 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.
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