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

Model Number CRS

Device Problems Reflux within Device (1522); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); Non specific EKG/ECG Changes (1817); Hemorrhage/Bleeding (1888); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 10/25/2018

Event Type  Injury  

Manufacturer Narrative

Citation: yamashita y.; et al.Comparison of cardiac energetics after transcatheter and surgical aortic valve replacements.Interact cardiovasc thorac surg.2019 apr 1;28(4):587-593.Doi: 10.1093/icvts/ivy292 pmid: (b)(4).Advance access publication 25 october 2018 earliest date of publication used for date of event.Medtronic products referenced: corevalve (pma# p130021, product code: npt); mosaic (pma# p990064, product code: dye).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

Medtronic received information via literature comparing levels of cardiac and hemodynamic improvement between patients who underwent surgical versus transcatheter aortic valve replacement (savr vs.Tavr).All data were collected from a single japanese medical center between january 2012 and september 2016.The study population included 117 patients who were predominantly female with a mean age of 81 years.Multiple manufacturer¿s devices were implanted in the study population.Among all patients, nine underwent tavr using medtronic corevalve bioprosthetic valves and one patient was surgically implanted with a medtronic mosaic bioprosthetic valve (unique device identifier numbers not provided).Among all tavr patients, adverse events included: atrioventricular block requiring permanent pacemaker implantation (ppmi) and significant aortic regurgitation.Among all savr patients, adverse events included: permanent pacemaker implantation (ppmi); bleeding requiring surgical re-exploration and cerebral infarction.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: COREVALVE 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: 14995031
• MDR Text Key: 295765079
• Report Number: 2025587-2022-01910
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 07/12/2022

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: Lay User/Patient
• Device Model Number: CRS
• Device Catalogue Number: CRS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/21/2022
• Initial Date FDA Received: 07/12/2022
• 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
• Patient Age: 81 YR
• Patient Sex: Female