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

Model Number EVOLUTPRO-29

Device Problems Unintended Collision (1429); Perivalvular Leak (1457); Inaccurate Delivery (2339); Device Dislodged or Dislocated (2923)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/26/2018

Event Type  Injury  

Manufacturer Narrative

Other relevant devices are: product id: enveor-l, serial/lot #: unknown, ubd: unknown, udi#: unknown.Product id: enveor-l, serial/lot #: (b)(4), ubd: 30-may-2019, udi#: (b)(4).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 placed too low due to bad positioning.A second transcatheter bioprosthetic valve, was successfully loaded with this delivery catheter system (dcs) and no misload was identified.The dcs was inserted and at two thirds deployment of the valve, the valve was partially deployed.The second valve dislodged the first valve too deep.The first valve was then snared into an acceptable position.The second dcs fully recaptured the second valve and the capsule was fully closed.The dcs with the second valve was removed.The second valve was not implanted at the conclusion of the procedure.It was noted that during the procedure the anatomy was found to be normal.No additional adverse patient effects were reported.

Manufacturer Narrative

Additional information reported that due to the low positioning of the first valve, paravalvular leak (pvl) was identified.Due to the pvl, the second valve was attempted to be placed.The second valve was partially deployed and recaptured.The second valve was repositioned and when crossing the annulus with the second delivery catheter system (dcs), the first valve dislodged deeper towards the ventricle.The dcs caused the dislodgement, not the second valve, as was previously reported.Due to the deep dislodgement, the first valve then caused interference with the mitral valve.The first valve was then snared into an acceptable location.The second dcs and second valve were then removed.No additional adverse patient effects were reported.D.Suspect medical device: updated the valve information.Updated the device information of the first delivery catheter system (dcs) (lot 0009219062): continuation of concomitant medical products: the main component of the system.Other relevant devices are: product id: enveor-l, serial/lot #: (b)(4), ubd: 03-july-2019, udi#: (b)(4).Product id: enveor-l, serial/lot #: (b)(4), ubd: 30-may-2019, udi#: (b)(4), (b)(4).Product analysis: the valve remains implanted and the dcs were discarded by the customer; therefore, no product analysis can be performed.Conclusion: without return of the products, no definitive conclusions could be drawn regarding the clinical observation.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information reported that the paravalvular leak (pvl) following the placement of the valve was moderate to severe.Following the snaring of the valve into an acceptable location, a second valve was not implanted.The outcome of the procedure was reported to be a perfect result.No additional adverse patient effects were reported.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.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 data: after further review, correction number 2025587-05-28-2021-001-r was determined to be applicable to product id: enveor-l, lot #: 0009165244, ubd: 30-may-2019, udi#: (b)(4) which was included as a system reported product in this event.The i nformation was added to h10 to align with the system-reported product.H7.Recall h9.Correction number: 2025587-05-28-2021-001-r.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, and should be considered redacted information.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 TRANSCATHETER AORTIC 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: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 8100631
• MDR Text Key: 128246248
• Report Number: 2025587-2018-03169
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P130021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/07/2019
• Device Model Number: EVOLUTPRO-29
• Device Catalogue Number: EVOLUTPRO-29
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2023
• Date Device Manufactured: 05/24/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 2025587-05-28-2021-001-R
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male