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

Model Number EVPROPLUS-34US

Device Problems Perivalvular Leak (1457); Material Split, Cut or Torn (4008)

Patient Problems Cusp Tear (2656); Heart Failure/Congestive Heart Failure (4446); Valvular Insufficiency/ Regurgitation (4449); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 08/10/2021

Event Type  Injury  

Manufacturer Narrative

Product analysis: the valve remains implanted therefore no product analysis can be performed.Conclusion: without return of the product, no definitive conclusion can be made regarding the clinical observation.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during the implant of this transcatheter bioprosthetic valve, the valve was implanted at 1/2 depth.Heavy calcification behind the valve was noted via echocardiogram and paravalvular leak (pvl) was observed.A post implant balloon aortic valvuloplasty (bav) was performed with a 26mm balloon after which pvl was moderate.15 days following implant of the valve the patient was admitted to the hospital due to heart failure and pvl was moderate to severe.A bav was performed with a 28mm non-medtronic balloon.After inflation central aortic regurgitation was noted.A second (34mm) valve was implanted without issue.The pvl and central regurgitation improved.The patient also improved hemodynamically.No additional adverse patient effects were reported.

Manufacturer Narrative

Additional information was received reporting that during the balloon aortic valvuloplasty (bav) performed with the 28mm balloon 15 days following the valve implant, 2 inflations were done because the 1st inflation went aortic.An in deflator was used with an inflation time of 3 seconds.Per the physician, the use of a larger balloon likely caused a leaflet tear.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

Additional information was received that the reported paravalvular leak (pvl) prior to the post valve implant bav during the initial procedure was moderate.Following the bav performed fifteen days following the initial implant, the central aortic insufficiency reported was severe.Updated b5 - description of 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.

Manufacturer Narrative

Conclusion: the valve was not returned to medtronic for analysis.Images were not received.Paravalvular leak (pvl) can be caused by a variety of factors, including valve positioning, patient anatomy, or presence of pre-existing patient conditions.A conclusive cause could not be determined from the limited information available.In this case it was reported that a post implant bav was performed using a 26mm non-medtronic balloon, after which the pvl was moderate.A relationship of the reported heart failure to the device or procedure could not be determined with the limited information available.Preliminary assessments of the cause(s) of the leaflet damage that were reported on the valve at implant, suggest that a post valve deployment intervention is possibly among the factors leading to damage of a leaflet and subsequent severe aortic insufficiency (ai).The true balloon is a non-compliant balloon.Per the instructions for use (ifu), a non-compliant balloon (for example, bard true¿* dilatation) should be at least 1 millimeter (mm) smaller than the diameter of the native aortic annulus.The maximum balloon size chosen for dilatation using a non-compliant balloon should not exceed 1 mm more than the transcatheter aortic valve (tav) waist diameter, with an applied inflation pressure of no greater than 2 atmospheres (atm).Overexpansion of the narrowest portion (waist) of the evolut pro+ tav beyond the levels set forth in the ifu, has been demonstrated through bench data to cause damage to the bioprosthetic leaflets.Complaints of damage to the bioprosthetic leaflets during post implant balloon dilatation have been reported in some clinical cases, resulting in moderate to severe aortic insufficiency, which may be detected acutely or during follow-up.It is important to note that the mechanical compliance properties of the selected balloon influence the dilatation dynamics.Balloons should not be inflated beyond 2 atm of applied pressure.Compliant and semi-compliant (softer) balloons will more readily conform to the hourglass profile of the tav at lower pressures but must be inflated at pressures that preserve the hourglass profile of the tav.Conversely, non-compliant (stiffer) balloons will achieve the nominal diameter during inflation irrespective of the underlying annulus or tav resistance and should be downsized.For additional instructions on the use of balloon catheter devices refer to the specific balloon catheter manufacturer's labeling.If larger balloon diameters than those listed in the ifu are required to expand the tav due to clinically important residual aortic regurgitation or stenosis, using ¿bailout¿ intraventricular balloon positioning when performing the post implant dilation (pid) avoids expansion of the narrowest portion (waist) of the tav.This can mitigate the risk of leaflet damage.Dilatation with intraventricular balloon positioning should be performed with caution in the setting of a smaller ventricle cavity, presence of left ventricular outflow tract (lvot) calcification, or wire positioning that interferes with mitral valve function, to avoid any unintended balloon interaction with anatomy.The balloon¿s length and diameter, along with the individual patient anatomy, must be considered.Care should also be taken not to exceed the annular diameters when performing pid with intraventricular balloon positioning.In the event that a bailout pid with intraventricular balloon positioning is performed, the nominal diameter of the balloon should not exceed the annular diameter when using compliant or semi-compliant balloons; the nominal diameter of the balloon should be at least 1 mm smaller than the annular diameter when using non-compliant balloons.Review of the device history report (dhr) for this device found it was built to specification and met all inspection and acceptance criteria.No issues were noted that would have impacted this event.It was also confirmed from the physician that the 28mm balloon most likely caused the leaflet tear.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.

Manufacturer Narrative

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

Corrected: h9.The previous correction number was submitted in error.The number should be 2025587-10-28-2020-001-c.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: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 12398981
• MDR Text Key: 269377930
• Report Number: 2025587-2021-02708
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00763000211158
• UDI-Public: 00763000211158
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/24/2023

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: 03/17/2023
• Device Model Number: EVPROPLUS-34US
• Device Catalogue Number: EVPROPLUS-34US
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/25/2021
• Initial Date FDA Received: 08/31/2021
• Supplement Dates Manufacturer Received: 08/31/2021; 09/13/2021; 10/12/2021; 03/20/2022; 02/23/2023
• Supplement Dates FDA Received: 09/10/2021; 09/21/2021; 10/25/2021; 10/29/2022; 02/24/2023
• Date Device Manufactured: 03/17/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 2025587-10-28-2020-001-C
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 87 YR
• Patient Sex: Male