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

Model Number D-EVPROP23-29

Device Problem Difficult or Delayed Activation (2577)

Patient Problems Hemorrhage/Bleeding (1888); Cardiac Tamponade (2226)

Event Date 11/02/2022

Event Type  Injury  

Event Description

Medtronic received information that during implant of this transcatheter bioprosthetic valve using this delivery catheter system (dcs), one deployment attempt was made.It was reported that it was difficult to release the paddle of the valve during the final step of the deployment.The paddle of the valve was reported to have been stuck within the capsule of the dcs, despite rotating the whole deployment knob.The implanting physician therefore had to push and rotate the dcs in order to deploy the valve.The final implant depth of the valve after release was noted to be 3/4 millimeter (mm).Of note, the valve was loaded properly with no misload noted.Cardiac tamponade occurred.A sternotomy was performed in order to stop the bleeding, which was successful.The patient recovered and was discharged.No additional adverse patient effects were reported.

Manufacturer Narrative

Concomitant medical products: other relevant device(s) are: product id: evproplus-26, serial/lot #: (b)(4), ubd: 12-may-2023, udi#: (b)(4).Product analysis: no product was returned.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.

Manufacturer Narrative

Updated data: h6 - method code, results code and conclusion code h10 - conclusion: it was reported that there was difficulty releasing the valve paddles (tabs) from the delivery catheter system (dcs).Per the device training materials, the user should release the tension in system just before final release to reduce potential for valve movement and the user should slightly push on delivery system while tuning the deployment knob very slowly to allow the paddles to detach one at a time.Additionally, per the training material, if paddle fails to immediately detach do not torque (turn) the delivery system handle as this will not translate to the distal tip.Often a hung paddle will resolve itself after a few heart cycles, but if it doesn¿t the operator can either pull slightly on the guidewire or gently push the delivery system forward to release the paddle.Cardiac tamponade occurred.A sternotomy was performed in order to stop the bleeding, which was successful.Cardiovascular injuries, such as cardiac tamponade, are known potential adverse patient effects per the evolut system instructions for use (ifu), and may be impacted by many factors including the patient's pre-procedural condition and procedural factors, as well as factors related to the device.Bleeding was also reported.Vascular access related complications are also a known potential adverse patient effect per the evolut system instructions for use (ifu), and are typically related to patient factors (anatomy, comorbidities, etc.), and/or procedural effects (sheath used, user technique, puncture cut location, etc.).There was no information to suggest a device malfunction or a failure to meet manufacturing specifications was related to these events.A medical safety assessment was carried out for this complaint.Upon review of the information provided, this event is assessed as likely device related to the valve deployment difficulties.The primary harm/adverse event cardiac tissue damage leading to tamponade requiring a sternotomy to repair was likely related to the repositioning required during valve deployment.A dhr review was also conducted for this event.Based on the device history record (dhr) review performed on the dcs, there were no correlations/issues identified regarding manufacturing.The device was manufactured per approved and released manufacturing processes and the device met all applicable manufacturing specifications prior to release for distribution.The dhr review did not show any findings related to 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 DCS
• 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: 15835579
• MDR Text Key: 304036362
• Report Number: 2025587-2022-03256
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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
• Type of Report: Initial,Followup
• Report Date: 02/16/2023

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/22/2023
• Device Model Number: D-EVPROP23-29
• Device Catalogue Number: D-EVPROP23-29
• Device Lot Number: 0011277803
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/09/2022
• Initial Date FDA Received: 11/21/2022
• Supplement Dates Manufacturer Received: 02/16/2023
• Supplement Dates FDA Received: 02/16/2023
• Date Device Manufactured: 06/22/2022
• 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
• Treatment: "SEE H10....".
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Sex: Female