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

Model Number ENVPRO-14

Device Problems Failure to Advance (2524); Patient Device Interaction Problem (4001)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 12/08/2021

Event Type  Injury  

Manufacturer Narrative

This report is being submitted as part of a retrospective review and remediation for capa 564121 per (b)(4).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, in a patient with a heavily calcified and extremely horizontal aorta, a pre-implant balloon aortic valvuloplasty (bav) was performed with an 18mm non-medtronic balloon.The delivery catheter system (dcs) was inserted into the patient, tracked over a non-medtronic wire, and was advanced through the patient.Near the intended implant position, the nosecone of the dcs would not advance across the native valve; it could not be positioned in the valve opening to allow the dcs to cross into the ventricle.It was noted the dcs would prolapse into the non-coronary sinus.The dcs was withdrawn from the patient.The wire was replaced with a different non-medtronic wire.The implant team was advised to switch to a new valve and dcs; however, the same dcs and valve were flushed and reinserted into the patient.The patient¿s pressures decreased, medication was administered, and the patient¿s pressures recovered.The patient remained in stable condition.The team re-advanced the dcs in a second attempt to cross the valve, but the dcs still could not cross the valve.The dcs was withdrawn from the patient.A second pre-implant bav was performed with a larger 22mm non-medtronic balloon.A new dcs and new valve were inserted into the patient, tracked over a non-medtronic wire, and advanced through the patient.At the native valve, the dcs still would not cross the valve.The implant team discussed further options to successfully cross the valve, but the ultimate decision was to abort the case.The second dcs was withdrawn from the patient.No valve was implanted.No adverse patient effects were reported.

• 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: 18789880
• MDR Text Key: 336349932
• Report Number: 2025587-2024-01175
• 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?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: ENVPRO-14
• Device Catalogue Number: ENVPRO-14
• Device Lot Number: 0010826602
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2021
• Date Device Manufactured: 08/31/2021
• 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): Life Threatening
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 81 KG