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

Model Number EVOLUTPRO-29

Device Problems Fluid/Blood Leak (1250); Patient Device Interaction Problem (4001)

Patient Problems Atrial Fibrillation (1729); Stroke/CVA (1770); Non specific EKG/ECG Changes (1817); Paresis (1998); Visual Impairment (2138); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 11/07/2018

Event Type  Injury  

Event Description

Medtronic received information that after the implant of this transcatheter bioprosthetic valve, aortography indicated trace unknown aortic regurgitation (ar).No treatment was required for the ar.The same day electrocardiogram (ecg) identified first degree atrio -ventricular block (avb) prolongation.An electrophysiological study was conducted and noted the atrio-ventricular (av) interval was further prolonged.A new left bundle branch block (lbbb) was observed.The new lbbb had a pr interval prolongation of 202 milliseco nds (ms).An unspecified treatment was reported for the lbbb.On the same day, paroxysmal atrial fibrillation was identified and treated with medication.Also, a stent was placed in the right coronary artery as a planned procedure.One day after the valve implant procedure, diplopia with light hemiparesis occurred.A cerebral vascular injury was noted.Computed tomography (ct) confirmed a subacute cerebral vascular infarction (cvi).Medication was prescribed.It was reported the medtronic device did not cause or contribute to the cvi; however, per the physician, the cvi was related to the valve implant procedure.The event required prolongation of hospitalization.The first degree avb and lbbb were noted as resolved.The cvi resolved with sequelae approximately eight months after onset.No additional adverse patient effects were reported.

Manufacturer Narrative

Select patient information cannot be included in the regulatory report due to regional privacy regulations.Continuation of d10: product id {envpro-16}; product lot/serial number (b)(6); product type: {delivery catheter system (dcs)}; implant date {na}; explant date {na} product id {l-envpro-16}; product lot/serial number (b)(6); product type: {compression loading system (cls)}; implant date {na}; explant date {na} product id {abbott proglide}; product type: {vascular closure device}; implant date {na}; explant date {na}.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.

Manufacturer Narrative

Added annex e codes.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.

Manufacturer Narrative

Updated/corrected data: h6 medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: EVOLUT PRO TRANSCATHETER AORTIC VALVE
• 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: 18799739
• MDR Text Key: 336473983
• Report Number: 2025587-2024-01243
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: SI
• PMA/PMN Number: P130021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/07/2024

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 Expiration Date: 09/13/2019
• Device Model Number: EVOLUTPRO-29
• Device Catalogue Number: EVOLUTPRO-29
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/28/2024
• Initial Date FDA Received: 02/28/2024
• Supplement Dates Manufacturer Received: 02/28/2024; 05/07/2024
• Supplement Dates FDA Received: 02/28/2024; 05/07/2024
• Date Device Manufactured: 10/02/2018
• 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
• Patient Age: 87 YR
• Patient Sex: Male
• Patient Weight: 55 KG