MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION EVOLUT PRO PLUS VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV

Model Number EVPROPLUS-29US

Device Problems Failure to Advance (2524); Device Dislodged or Dislocated (2923); Activation Failure (3270)

Patient Problems Cardiac Arrest (1762); Stroke/CVA (1770); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/19/2022

Event Type  Death  

Manufacturer Narrative

Continuation of concomitant medical products: the main component of the system.Other relevant device(s) are: product id: d-evprop2329us, serial/lot #: (b)(4), ubd: , udi#: (b)(4).Product analysis: the valve remains implanted in the ascending aorta.The delivery catheter system (dcs) was discarded, therefore no product analysis can be performed.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.

Event Description

Medtronic received information that during implant of this transcatheter bioprosthetic valve into a patient with heavily calcified native aortic valve, at 80% deployment, it was reported that the valve was significantly constrained, and was at a depth of -2 mm on the non-coronary cusp (ncc).Prior to full release, the inflow portion of the valve "watermelon seeded" and dislodged above the annulus on all sides.The implanting physician attempted to recapture the valve.The recapture of the valve was not possible because the ncc side of the valve's outflow crown was outside of the capsule of the delivery catheter system (dcs).The implanting physician was instructed to withdrawn the valve into the ascending aorta and fully deploy the valve above the sinotubular junction and coronary ostia.A snare was inserted and used to hold the embolized valve in place within the ascending aorta.A second transcatheter valve was loaded onto a second dcs.The dcs was inserted via an 18 fr non-medtronic sheath via the left common femoral artery.The dcs was advanced up to the aortic arch but was unable to advance past significant calcium burden on the superior wall of the arch.Multiple attempts to cross the arch with the dcs were made while changing the position of the flush ports and catheter spines.All attempts were unsuccessful.The dcs was removed and a snare was inserted and advanced into the descending aorta.A left ventricle wire and catheter were placed through the snare.The left ventricle wire was exchanged through the pigtail catheter and snare.The pigtail catheter was removed.The dcs was advanced on the wire, through the snare, up to the aortic arch.The snare was tightened around the distal marker on the dcs capsule.The dcs and snare were advanced but were initially unsuccessful crossing the calcified aortic arch.The implanting physician lost wire access in the left ventricle.All products were removed and the wire was re-inserted into the left ventricle.The snare and dcs were eventually able to cross the calcified aortic arch, but were unable to cross through the embolized valve in the ascending aorta.The dcs and snare were retracted to proximal to the aortic arch.The snare was repositioned on the dcs capsule were advanced into and through the embolized valve.The dcs was not able to cross the native aortic valve.The implanting physician attempted to balloon deflect the dcs through the native aortic valve.The patient lost blood pressure and coded.Cardiopulmonary resuscitation (cpr), advanced resuscitation tools, and medications were administered.The patient was able to restore rhythm and native pressure.The implant of the second valve was aborted and all devices were removed.No additional adverse patient effects were reported.

Manufacturer Narrative

Updated data: b2 - outcome attributed to adverse event updated to include death and life threatening b5 - additional information was received that a couple of days following the procedure, the patient had a stroke and subsequently died.The cause of death was not provided.H1 - type of reportable event h6 - patient code additional codes - imf codes 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

Updated: b2 - date of death is estimated.Per the physician, the exact date of death will not be provided due to patient privacy.B5 - additional information was received indicating that no pre-implant balloon aortic valvuloplasty (bav) or post-implant bav was performed.Per the physician, the cause of the stroke was unknown.It was reported that prior to the procedure, computed tomography (ct) showed significant calcium on the superior aspect of the aortic arch, as well as calcification on the aortic annulus and leaflets.Per the physician, the cause of death was the stroke.Per the physician, it was unknown whether the valve caused or contributed to the stroke and subsequent death.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

Updated data: h6.Eval code method, eval code result, and eval code conclusion all updated in regards to the valve and under expansion of the valve frame.Conclusion: no device was returned for analysis and no procedural images were submitted for review.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.Potential factors that can influence a dislodged valve include tension applied on the delivery catheter system during positioning, calcification levels in the native vessel, inadequate deployment due to improper sizing between valve and annulus, irregular patient anatomy, or incomplete frame expansion.Dislodge events are typically not related to a device malfunction.This event does not allege a device malfunction occurred.The most likely cause for the valve dislodgement may have been the reported under expansion of the valve.A variety of factors can influence the onset of stroke.It is a known potential adverse effect per the device instructions for use.It is unknown if the reported significant calcium on the superior aspect of the aortic arch as well as calcification on the aortic annulus and leaflets played a role in the reported stroke that then led to the patient death.As neither an autopsy nor an explant was performed, a conclusive assessment of the relationship between the event and the device could not be reached.A procedure- or valve-related death is an inherent risk when the patient condition is such that a percutaneous aortic valve is needed to sustain cardiac function, and it can occur despite an ideal implant procedure or device functionality.No allegations were made against the device, and there was no indication that a malfunction or misuse contributed to the reported events.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

Conclusion: difficulties advancing the delivery catheter system (dcs) through the aortic arch 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 significant calcium burden on the superior wall of the arch.This indicates that the probable cause of the advancement difficulties was patient anatomy, but this cannot be confirmed with the limited information available.Cardiac failure and cardiac arrest are known potential adverse effect per the device instructions for use (ifu).These events may be related to patient medical condition, comorbidities, and/or procedural factors.Based on the limited information available, an assignable root cause of the heart failure and cardiac arrest cannot be determined and the relationship to the device could not be established.The device history record of the dcs 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.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.

• Brand Name: EVOLUT PRO PLUS VALVE
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 15126241
• MDR Text Key: 296839871
• Report Number: 2025587-2022-02125
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00763000211127
• UDI-Public: 00763000211127
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/07/2022

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/24/2024
• Device Model Number: EVPROPLUS-29US
• Device Catalogue Number: EVPROPLUS-29US
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/19/2022
• Initial Date FDA Received: 07/28/2022
• Supplement Dates Manufacturer Received: 07/28/2022; 08/11/2022; 10/03/2022; 10/05/2022
• Supplement Dates FDA Received: 08/11/2022; 08/30/2022; 10/04/2022; 10/07/2022
• Date Device Manufactured: 03/25/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention; Life Threatening
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 57 KG