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

Model Number D-EVPROP23-29

Device Problems Fracture (1260); Patient Device Interaction Problem (4001)

Patient Problem Cardiovascular Insufficiency (4445)

Event Date 12/01/2021

Event Type  Injury  

Manufacturer Narrative

This report is being submitted as part of a retrospective review and remediation for capa 564121 per (b)(4).Product analysis: upon receipt at medtronic¿s quality laboratory, the handle of the delivery catheter system (dcs) was intact.The device was returned with the end cap separated.The deployment knob did not retract and advance the capsule.The trigger did not advance or retract the capsule.The tip-retrieval mechanism appeared intact.The end cap was reattached by the analysis technician.Once the end cap was reattached, the deployment knob and the trigger could retract and advance the capsule.The device was received with the capsule fully closed.Delamination was observed over the nitinol reinforcing frame along the mid-section to the proximal end of the caps.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

Medtronic received information that during the implant of this transcatheter bioprosthetic valve, a ventricular suicide was noted.It was attempted to release the valve quickly however the end cap separated.The delivery catheter system (dcs) was pushed back together and was rotated until the valve was released.There was no time to recapture and remove the system as cardiopulmonary resuscitation (cpr) was required.It was reported that the valve was not misloaded.No adverse patient effects were reported.

• 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: 18788709
• MDR Text Key: 336338821
• Report Number: 2025587-2024-01166
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P130021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/10/2022
• Device Model Number: D-EVPROP23-29
• Device Catalogue Number: D-EVPROP23-29
• Device Lot Number: 0010715202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2021
• Date Device Manufactured: 06/10/2021
• 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
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Sex: Male