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

Model Number CRS

Device Problems Perivalvular Leak (1457); Patient Device Interaction Problem (4001); Central Regurgitation (4068)

Patient Problems Valvular Insufficiency/ Regurgitation (4449); Aortic Valve Insufficiency/ Regurgitation (4450); Insufficient Information (4580)

Event Date 07/25/2011

Event Type  Injury  

Manufacturer Narrative

Citation: schultz et al.Correlates on msct of paravalvular aortic regurgitation after transcatheter aortic valve implantation using the medtronic corevalve prosthesis.Catheter cardiovasc interv.2011 sep 1;78(3):446-55.Doi: 10.1002/ccd.22993.Epub 2011 jul 25.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 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Literature was reviewed regarding paravalvular leak after transcatheter aortic valve replacement (tavr).The study population included 56 patients with a mean age of 80 years who were predominantly male.  all patients were implanted with a medtronic corevalve bioprosthetic valve.  among the study population one death occurred; the patient had severe kiphoscoliosis with an unusual anatomy, and died one week post-tavr implant.  no further details were provided on this death.  among all patients adverse events included: severe aortic regurgitation, severe paravalvular leak, and valve malposition.  no further information was provided pertaining to medtronic products.

• 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: 18992018
• MDR Text Key: 338806738
• Report Number: 2025587-2024-01954
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/27/2024

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: CRS
• Device Catalogue Number: CRS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/20/2024
• Initial Date FDA Received: 03/28/2024
• 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
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male