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

Model Number MDT-TRANS VALVE

Device Problems Inadequacy of Device Shape and/or Size (1583); Migration (4003)

Patient Problems Stroke/CVA (1770); Non specific EKG/ECG Changes (1817); Cardiovascular Insufficiency (4445); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 11/19/2022

Event Type  Injury  

Manufacturer Narrative

Citation: nuis et al.Balloon expandable vs.Self-expanding transcatheter valve for degenerated bioprosthesis: design and rationale of the baseline trial.Am heart j.2023 feb;256:139-147.Doi: 10.1016/j.Ahj.2022.11.013.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.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 via literature regarding balloon expandable vs.Self-expanding transcatheter valve as valve-in-valve implants for degenerated bioprostheses.  data collection from 50 centers was initiated in november 2021, however the results were not yet available.  multiple manufacturer¿s devices were implanted in the study population; an unspecified number of patients were implanted with a medtronic evolut pro+ bioprosthetic valve.  no unique device identifier numbers were provided.In a meta-analysis review of 10 previously published studies, 30-day and 1-year mortalities occurred.  no further details were provided on the deaths.  there was no statement of causal or contributory relationship between medtronic product and the deaths.Additionally, these adverseevents were observed: valve migration requiring second valve implant, coronary occlusion, stroke, arrhythmia requiring permanent pacemaker implant, mean gradient > 20 mmhg, severe patient-prosthesis mismatch (ppm), and moderate to severe aortic regurgitation (ar).  based on the available information medtronic product may have been associated with the adverse events.No additional adverse patient effects or product performance issues were reported.

• 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: 16244576
• MDR Text Key: 308145900
• Report Number: 2025587-2023-00313
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: P130021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/25/2023

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: 01/17/2023
• Initial Date FDA Received: 01/25/2023
• 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): Required Intervention; Life Threatening