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

Model Number MDT-TRANS VALVE

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

Patient Problems Atrial Fibrillation (1729); Atrial Flutter (1730); Cardiac Arrest (1762); Stroke/CVA (1770); Non specific EKG/ECG Changes (1817); Hemorrhage/Bleeding (1888); Myocardial Infarction (1969); Transient Ischemic Attack (2109); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 11/13/2023

Event Type  Injury  

Event Description

Literature was reviewed regarding the relationship between fluoroscopy time and outcomes after transcatheter aortic valve replacement (tavr).Medtronic (corevalve, engager, evolut r, evolut pro, and evolut pro+) and non-medtronic (various) transcatheter valve types were used in the study.The authors observed a total of 102 deaths within one year of tavr.No evidence was presented to suggest that a medtronic valve or its function contributed to any of the deaths.Other adverse outcomes consisted of bleeding, transfusions, vascular complications (minor or major), access site related vascular complications, residual aortic regurgitation (at least moderate), permanent pacemaker implantation, external cardiac massage/cardiac arrest, new atrial fibrillation/flutter, myocardial infarction, stroke/transient ischemic attack, extended hospital stay, prolonged fluoroscopy time, acute kidney injury (with or without continuous venovenous hemofiltration), and chronic hemodialysis.No additional adverse outcomes were noted.

Manufacturer Narrative

Continuation of d10: this is a system report.The section d information is for the primary device, which was in use with the following: medtronic transcatheter delivery system, product id: mdt-trans dcs, lot number(s): unknown.Citation: cafaro a, spione f, burattini o, et al.Fluoroscopy time as a new predictor of short-term outcomes after transcatheter aortic valve replacement.J cardiovasc dev dis.2023;10(11):459.Published 2023 nov 13.Doi:10.3390/jcdd10110459 earliest date of publication used for date of event.Fda approved medtronic products referenced: corevalve (product code npt, pma# p130021), evolut r (product code npt, pma# p130021), evolut pro (product code npt, pma# p130021), and evolut pro+ (product code npt, pma# p130021).Earliest approved product used for product code and pma#.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.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 received from the corresponding author indicated that none of the adverse events or deaths observed in the study were exclusively linked to a medtronic device.No further information was provided.

Manufacturer Narrative

Updated information: b5.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: MEDTRONIC TRANSCATHETER 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: 18822328
• MDR Text Key: 336736104
• Report Number: 2025587-2024-01319
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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,Followup
• Report Date: 03/18/2024

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: MDT-TRANS VALVE
• Device Catalogue Number: MDT-TRANS VALVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/20/2024
• Initial Date FDA Received: 03/01/2024
• Supplement Dates Manufacturer Received: 03/17/2024
• Supplement Dates FDA Received: 03/18/2024
• 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
• Treatment: "SEE H11...."
• Patient Outcome(s): Required Intervention; Life Threatening; Hospitalization
• Patient Age: 81 YR
• Patient Sex: Female