MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION ENVEO PRO DELIVERY SYSTEM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV

Model Number ENVPRO-16

Device Problem Difficult to Advance (2920)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/16/2023

Event Type  Injury  

Manufacturer Narrative

Citation: tsuda et al.Double-snare technique to facilitate second transcatheter self-expandable valve delivery inside an embolized valve.Images in cardiovascular intervention.2024, vol 39, p97¿98.Doi.Org/10.1007/s12928-023-00960-9.Earliest date of publication used for date of event.No unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported.Without return of the product no definitive conclusion can be made regarding the clinical observations.Select patient information cannot be included in regulatory report due to regional privacy regulations.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.

Event Description

Literature was reviewed regarding a patient with exercise dyspnea and severe aortic stenosis who underwent transcatheter aortic valve replacement with implant of a medtronic 26-mm evolut pro+ bioprosthetic valve.Following deployment from the delivery catheter system, the valve embolized and migrated into the ascending aorta.As the patient was hemodynamically stable a second evolut pro+ valve was attempted.However, while advancing the second valve there was difficulty in passing the first valve on greater curvature of the ascending aorta despite stabilizing the first valve with a snare catheter.With use of a second catheter to allow for controlled traction on the second valve, it was advanced thru and past the first valve.The second valve was successfully implanted in an optimal position without any complication.No further information was provided pertaining to medtronic products.

• Brand Name: ENVEO PRO DELIVERY SYSTEM
• 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: 18717722
• MDR Text Key: 335522200
• Report Number: 2025587-2024-00934
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P130021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/15/2024

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 Model Number: ENVPRO-16
• Device Catalogue Number: ENVPRO-16
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/24/2024
• Initial Date FDA Received: 02/15/2024
• 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): Life Threatening; Required Intervention; Hospitalization