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

Model Number ENVPRO-14

Device Problems Unintended Collision (1429); Device Dislodged or Dislocated (2923)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 12/06/2021

Event Type  Injury  

Event Description

Medtronic received information that during the implant of this transcatheter bioprosthetic valve, in a patient with severe aortic valve calcification, a pre-implant balloon aortic valvuloplasty (bav) was performed with a 22mm non-medtronic balloon.Upon assessment of the initial valve deployment, the valve frame did not expand as expected; the valve was recaptured.A second bav was performed with the same balloon.A second deployment was attempted; however, the valve frame remained under expanded.The patient¿s blood pressure was low and the valve was fully released.As the delivery catheter system was withdrawn, the valve was dislodged.A snare was used to move the valve into the ascending aorta where it remained.Subsequently, a non-medtronic valve was successfully implanted.No additional adverse patient effects were reported.

Manufacturer Narrative

Other relevant device(s) are: product id: e volutr-29, serial/lot #: (b)(4), ubd: 29-jul-2022, udi#: (b)(4).Product analysis: the valve remains implanted and the delivery catheter system (dcs) was discarded by the customer; therefore, no product analysis can be performed.  conclusion: without return of the products, no definitive conclusions could be drawn regarding the clinical observation.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Conclusion: the reported event indicates that upon assessment of the initial valve deployment, the valve frame did not expand as expected, and was recaptured.Recapturing is a feature of the evolut system that allows for additional attempts at accurately positioning the valve.Various factors can affect valve positioning including patient anatomy or physician technique.There is no information to suggest a device quality deficiency that may have caused or contributed to this event, but the cause of the positioning difficulty could not be conclusively determined with the available evidence.Positioning difficulties do not typically indicate a device malfunction or a failure to meet manufacturing specifications.A second balloon aortic valvuloplasty (bav) was performed with the same balloon.A second deployment was attempted; however, the valve frame remained under expanded.The patient¿s blood pressure was low and the valve was fully released.Hypotension is a known potential adverse effect per device instructions for use (ifu).It is an effect that is highly dependent on the patient's pre-procedural condition and can occur despite a normally-functioning device or model implant procedure, and a conclusive cause could not be determined from the limited information available.As the delivery catheter system was withdrawn, the valve was dislodged.Dislodgement of the valve by the distal tip is related to operator technique or experience; the enveo pro instructions for use, instructs ¿under fluoroscopic guidance, confirm that the catheter tip is coaxial with the inflow portion of the bioprosthesis¿ prior to drawing the dcs tip through the valve.No images from the procedure were received for review; given the limited information, the root cause of the dislodgement event cannot be confirmed.Events of this type do not indicate a device malfunction or a failure to meet manufacturing specifications.A snare was used to move the valve into the ascending aorta where it remained.Subsequently, a non-medtronic valve was successfully implanted.No additional adverse patient effects were reported.Updated results and conclusion codes in 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: 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: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 13169982
• MDR Text Key: 283260070
• Report Number: 2025587-2022-00022
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 02/18/2022

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 Expiration Date: 10/01/2023
• Device Model Number: ENVPRO-14
• Device Catalogue Number: ENVPRO-14
• Device Lot Number: 0010877476
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/09/2021
• Initial Date FDA Received: 01/05/2022
• Supplement Dates Manufacturer Received: 02/03/2022
• Supplement Dates FDA Received: 02/18/2022
• Date Device Manufactured: 10/01/2021
• 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
• Treatment: "SEE H10...."
• Patient Outcome(s): Required Intervention; Required Intervention; Life Threatening; Life Threatening
• Patient Age: 95 YR
• Patient Sex: Female