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

Model Number D-EVPROP34

Device Problem Break (1069)

Patient Problem Obstruction/Occlusion (2422)

Event Date 01/25/2023

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

Medtronic received information that during implant of this transcatheter bioprosthetic valve, while removing the large sheath and beginning to access the delivery catheter system (dcs) using the inline sheath, the capsule did not advance.The team stopped and screened the patient.Visualization showed the capsule but the nosecone was not visible.The team withdrew the system from the artery and the nose cone was missing.The patient was rescreened which revealed the nosecone stuck inside the patient.Pressure was applied to the left femoral artery as a sheath could not be advanced for hemostasis due to the nosecone obstruction.The guidewire appeared kinked/steep bend.A radial access site was used to add a supporting guidewire to deliver a 10 millimeter (mm) antegrade balloon to restrict blood flow and maintain hemostasis.Vascular surgery was called as the patient remained stable.The patient was placed under general anesthesia as the surgeon operated to remove the nosecone.The nose cone was retrieved safely.The surgeon concluded that the original puncture was high and went through the inguinal ligament.As a result, the dcs could not advance through the ligament and the nosecone became trapped, snapping off and detaching from the system.The surgeon performed a vascular cutdown and a new dcs was advanced.A new valve was deployed uneventfully.No additional adverse patient effects were reported.

Manufacturer Narrative

Updated data: b5 - event description h6 - method and conclusion codes h10 - 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.Images were provided for review.Images showed the delivery catheter system (dcs) outside of the body with a missing nose cone as reported.An image showed a fluoroscopic image of the nosecone tip free from the delivery system over the working wire stuck in the inguinal fold as reported.Tip detachment can occur if the inner member shaft becomes damaged and breaks.Historically, inner member shaft damage and a subsequent break is caused by manipulation (twisting and/or bending) of the dcs by the user or is related to excessive forces applied on the system during advancement or positioning, or it may occur if the capsule is not fully closed prior to removal of the dcs.In this case, the surgeon concluded that the original puncture was high and went through the inguinal ligament.As a result, the dcs could not advance through the ligament and the nosecone became trapped, snapping off and detaching from the system.This event was reviewed by research and development, and it was noted that the delivery catheter system appeared to have been subjected to excessive forces during advancement due to an incorrect puncture site leading to the delivery system being subjected to forces when attempting to pass through the inguinal ligament leading to the nosecone becoming trapped and subsequently detaching from the system.The delivery system has not been designed to penetrate through this type of anatomical structure and therefore is not compatible with this type of use.There is no information to suggest a device malfunction or a failure to meet manufacturing specifications.A medical safety assessment was performed and based on the information provided, the primary event of obstruction was due to the separated nosecone.It was reported that the nosecone was incorrectly positioned in the inguinal fold and therefore obstructed advancement of the sheath.All adverse events and severities noted in this event are documented in the risk management files and within the instructions for use.No further safety assessment required, and no further action is needed as this complaint did not identify any unexpected serious adverse events.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

Additional information was received that when withdrawing the delivery catheter system (dcs), the capsule was closed until it was aligned with the catheter tip.There was a procedure delay reported as a result of the nose cone separation due to the surgical intervention.

Manufacturer Narrative

Product analysis: upon receipt at medtronic¿s quality laboratory, the handle of the subject delivery catheter system (dcs) was intact.The nose cone was received separated from the inner member.Part of the lining of the inner member shaft remained within the nosecone.The detachment site on the inner member had 5 parts of the inner member shaft threading protruding from the lining.On retraction of the capsule via the rotation of the deployment knob, the valve deployed with an infold.The deployment knob retracted and advanced the capsule.The trigger moved to fully advanced and retracted positions and locked in place when released.The tip-retrieval mechanism was intact.The device was returned with the end cap/screw gear snap fit connected.There was a dent to the capsule tip.Conclusion: the investigation is in-progress.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.

• 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: 16258902
• MDR Text Key: 308308760
• Report Number: 2025587-2023-00328
• 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,Followup,Followup
• Report Date: 04/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2023
• Device Model Number: D-EVPROP34
• Device Catalogue Number: D-EVPROP34
• Device Lot Number: 0011481812
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2022
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 105 KG