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

Model Number EVOLUTFX-23

Device Problems Perivalvular Leak (1457); Failure to Advance (2524); Device Dislodged or Dislocated (2923); Activation Failure (3270)

Patient Problems Low Blood Pressure/ Hypotension (1914); Great Vessel Perforation (2152); Pericardial Effusion (3271); Valvular Insufficiency/ Regurgitation (4449)

Event Date 10/26/2022

Event Type  Injury  

Event Description

Medtronic received information that following the implant of this 23 millimeter (mm) transcatheter bioprosthetic valve the post echo cardiogram identified mild-moderate paravalvular leak (pvl).A 20mm non-medtronic balloon further expanded the valve which resulted in little improvement of the pvl.As result, a 22mm non-medtronic balloon was then used.When inflated, the balloon moved aortic and took the valve with it.A gooseneck snare was used to pull the valve up to the ascending aorta.A second 23mm valve was attempted.However, this system would not cross the first valve.The blood pressure dropped abruptly.This second system was removed.Another cardiac echocardiogram was performed and revealed a ¿significant¿ pericardial effusion.A pericardiocentesis was performed followed by chest compressions.As reported, the aorta was perforated due to the initial valve dislodgment and subsequent attempt to deliver a second valve.The patient was successfully placed on bypass and sternotomy surgery was completed successfully.The aorta was repaired and the transcatheter valve was explanted.No additional adverse patient effects were reported.

Manufacturer Narrative

Concomitant medical products: other relevant device(s) are: product id: d -evolutfx-2329, serial/lot #: 0011363657, ubd: 19-aug-2023, udi#: (b)(4) product analysis: the valve and delivery catheter system (dcs) were not returned, therefore no product analysis can be performed.Conclusion: without return of the products, no definitive conclusions could be drawn 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.

Manufacturer Narrative

Updated b5.Updated h6 - the concomitant product, the delivery catheter system (dcs) was discarded.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

Additional information was received which confirmed that the mid-moderate pvl was due to under expansion of the valve.Calcification contributed to the expansion issues.Prior to the dislodgement, the valve depth was reported as 3 mm on the non-coronary cusp (ncc) and 4 mm on the left coronary cusp (lcc).Following dislodgement, the depth was -4 mm on the ncc and - 4mm on the lcc, in the sinus of valsalva (sov).A safari wire was used during this implant.Of note, a pre-implant balloon aortic valvuloplasty (bav) was performed.

Manufacturer Narrative

Conclusion: the device history record for the delivery catheter system (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.Difficulties advancing the delivery catheter system (dcs) through the access 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 the previously implanted valve had dislodged.This indicates that the probable cause of the advancement difficulties was patient anatomy, but this cannot be confirmed with the limited information available.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: the valve was not returned to medtronic for product analysis.Images were submitted to medtronic for review.The image review contained one media file.The patient summary was provided for anato mical review.Based on annulus measurements, the appropriate valve size was selected.Per medtronic best practices, to mitigate risk of trauma to the annulus and damage to the evolut¿ tav leaflets, selected post-implant dilatation (pid) balloon size should not exceed the limits set forth in the tables.Annulus perimeter derived diameter was 20mm, so the max balloon diameter for a compliant/semi-compliant balloon would be 20mm and 19mm for a non-compliant balloon.Three images show the valve position before the balloon aortic valvuloplasty (bav), during bav with dislodgment, and final valve position post bav.Paravalvular leak (pvl) can be caused by a variety of factors, including valve positioning, patient anatomy, or presence of pre-existing patient conditions.It was reported that the pvl was due to under expansion of the valve, but medtronic could not confirm this with the information available.Potential factors that can influence a dislodged valve include tension applied on the delivery catheter system (dcs) during positioning, calcification levels in the native vessel, compliance of the aorta and native vessels, and a number of others.In this case, the initial valve depth was 3mm on the non-coronary cusp (ncc) and 4mm on the left coronary cusp (lcc), which is within the ifu-recommended target depth range of 1 to 5mm.However, it was reported that a 22mm true (non compliant) balloon was used for the post-implant bav, which when inflated moved aortic and took the valve with it.In addition the usage of a 22mm balloon exceeded the ifu guidance of a maximum balloon size of 19mm.Thus, the cause of the dislodgement was most likely user related.Dislodge events are typically not related to a device malfunction.Per the device instructions for use (ifu), in the event that valve function or sealing is impaired due to excessive calcification or incomplete expansion, a post-implant balloon dilation of the bioprosthesis may improve valve function and sealing.To ensure patient safety, valve size and patient anatomy must be considered when selecting the size of the balloon used for dilatation.¿ the balloon size chosen for dilatation should not exceed the diameter of the native aortic annulus.Refer to the specific balloon catheter manufacturer's labeling for proper instruction on the use of balloon catheter devices.It was reported that calcification contributed to the expansion issues and that use of a 20mm non-medtronic (true) balloon further expanded the valve.The patient calcification, which was verified in the patient summary, may have been a contributing cause.Pericardial effusion is a known effect that can occur after cardiac procedures due to procedural complications.It was reported the aorta was perforated due to the initial valve dislodgment and subsequent attempt to deliver a second valve.In addition, per the evolut ifu, repositioning of a fully deployed valve is not recommended and can result in adverse effects such as aortic root damage, coronary artery damage, myocardial damage, vascular complications, prosthetic valve dysfunction, embolization, stroke, and/or emergent surgery.The snaring and attempts to deliver a second valve were likely contributing causes.Hypotension is a known potential adverse effect per the device ifu.It is an effect that is highly dependent on the patient's pre-procedural condition and can occur despite a normally-functioning device or model implant procedure.The pericardial effusion was a likely contributing cause.Review of the device history record (dhr) (f001712) and frame record (1203933) for this device was performed.Based on the dhr review, all process parameters were within specification as outlined in applicable procedures and specifications.All materials used were as per the requirements of the dhr.All processes were carried out as per relevant procedures and met specification.There is no information to suggest a device quality deficiency that may have caused or contributed to this event.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.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 FX 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: 15845886
• MDR Text Key: 304135302
• Report Number: 2025587-2022-03279
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00763000370688
• UDI-Public: 00763000370688
• 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
• Report Date: 05/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/12/2023
• Device Model Number: EVOLUTFX-23
• Device Catalogue Number: EVOLUTFX-23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/05/2023
• Date Device Manufactured: 12/12/2021
• 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
• Treatment: "SEE H10...."
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Age: 78 YR
• Patient Sex: Female