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

Model Number EVPROPLUS-29US

Device Problems Perivalvular Leak (1457); Device Dislodged or Dislocated (2923); Material Split, Cut or Torn (4008)

Patient Problems Cusp Tear (2656); Valvular Insufficiency/ Regurgitation (4449)

Event Date 12/28/2020

Event Type  Injury  

Manufacturer Narrative

Other relevant device(s) are: product id: evproplus-29us, serial #: (b)(4), ubd: 29-may-2022, udi#: (b)(4).Product id: d-evprop2329us, lot #: 0010400524, ubd: 02-oct-2022, udi#: (b)(4).Product analysis: valve (b)(4) remains implanted, and valve (b)(4) and delivery catheter system (dcs) 0010400524 were discarded by the customer, therefore no product analysis can be performed.Conclusion: without return of the products, 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 29mm transcatheter bioprosthetic valve, in which left subclavian (lcs) access was used due to significant peripheral vascular disease (pvd), the valve was deployed after being recaptured 3 times because the valve was too deep.Moderate paravalvular leak (pvl) was noted on transesophageal echocardiogram (tee).A post-implant balloon aortic valvuloplasty (bav) with a 25 mm non-medtronic balloon was performed but the pvl was unchanged.A post-implant bav with a 26 mm non-medtronic balloon was performed after which one valve leaflet appeared to be torn on tee and the patient developed moderate to severe central aortic insufficiency.Placement of a second 29mm valve with a new delivery catheter system (dcs) was attempted but upon deployment, the first valve dislodged toward the aorta.The second valve appeared to be undersized and was thus recaptured and removed.A 34 mm valve was implanted.No additional adverse patient effects were reported.

Manufacturer Narrative

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.Paravalvular leak (pvl) can be caused by a variety of factors, including valve positioning, patient anatomy, or presence of pre-existing patient conditions, and a conclusive cause could not be determined from the limited information available.However, in this case, the deep implant position of the valve may have played a role in the reported moderate pvl.Based on the available information, preliminary assessments of the cause(s) of the leaflet damage suggest that a post valve deployment intervention is possibly among the factors leading to the damage of the leaflet, as it was stated that the user used a non-compliant balloon.It is suspected that the use of this non-compliant balloon most likely over expanded the waist of the transcatheter valve, thus leading to the reported valve leaflet tear and severe aortic insufficiency that was noted by the user on tee.However, without review of echo/cine/angio files for this case or analyzing a returned valve, and without knowing the actual inflation pressures of the post-implant bav, we cannot conclusively determine the cause for the damage.Dislodgement of the valve by the distal tip is related to operator technique or experience.The device instructions for use, instructs ¿under fluoroscopic guidance, confirm that the catheter tip is coaxial with the inflow portion of the bioprosthesis¿ prior to drawing the delivery catheter system (dcs) tip through the valve.No images from the procedure were received for review.Given the limited information, the root cause of the dislodgement event cannot be confirmed.In this case improper sizing of the patient¿s annulus to fit the size valve may have played a role in this event, as it was stated that a larger 34 millimeter (mm) valve was implanted successfully after the smaller 29 mm valve was withdrawn.Events of this type do not indicate a device malfunction or a failure to meet manufacturing specifications.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 DELIVERED
• 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: 11217748
• MDR Text Key: 228406874
• Report Number: 2025587-2021-00244
• 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
• Remedial Action: Recall
• Type of Report: Initial,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: 04/27/2022
• 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: 12/28/2020
• Initial Date FDA Received: 01/22/2021
• Supplement Dates Manufacturer Received: 01/26/2021; 03/20/2022; 02/23/2023
• Supplement Dates FDA Received: 02/16/2021; 10/29/2022; 02/24/2023
• Date Device Manufactured: 05/13/2020
• 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): Required Intervention
• Patient Age: 92 YR
• Patient Sex: Male