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

Model Number CRS

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problems Hemolysis (1886); Valvular Insufficiency/ Regurgitation (4449); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/15/2020

Event Type  Injury  

Manufacturer Narrative

This report is being submitted as part of a retrospective review and remediation for capa 564121 per d00916038.Citation: sirakova et al.Intravascular haemolysis after transcatheter aortic valve implantation with self-expandable prosthesis: incidence, severity, and impact on long-term mortality.Eur heart j suppl.2020 jul;22(suppl f):f44-f50.Doi: 10.1093/eurheartj/suaa098.Epub 2020 jul 15.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 intravascular hemolysis after transcatheter aortic valve replacement (tavr) with self-expandable prostheses.All data were collected from a single center between april 2009 and january 2014.The study population included 94 patients (predominantly male, mean age 80 years).All patients were implanted with a medtronic corevalve bioprosthetic valve (unique device identifier numbers not provided).Among all patients, 8 deaths occurred within one year and 67 deaths occurred within the 6-year long-term follow-up period.Of note, two of the eight early deaths were described as periprocedural complications.No further details were provided on these deaths.Based on the available information medtronic product may have been associated with these two deaths.Among all patients, adverse events included: hemolysis, severe paravalvular leak (no central aortic regurgitation was observed), and severe patient-prosthesis mismatch (ppm).There was no statement of intervention to treat these observations.No additional adverse patient effects or product performance issues were reported.April 9, 2022 / hartzp1: additional information received from the physician/author stated that: 1) none of the observed complications were directly related to corevalve device dysfunction, and 2) that patient information would not be provided due to privacy laws.No further details were provided.

• 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: 18893939
• MDR Text Key: 337539362
• Report Number: 2025587-2024-01593
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: EZ
• 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
• Report Date: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CRS
• Device Catalogue Number: CRS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2022
• 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
• Patient Age: 80 YR
• Patient Sex: Male