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

Model Number MCS-P3-29-AOA

Device Problems Perivalvular Leak (1457); Patient Device Interaction Problem (4001); Material Split, Cut or Torn (4008); Central Regurgitation (4068)

Patient Problems Stroke/CVA (1770); Thromboembolism (2654); Cusp Tear (2656); Speech Disorder (4415); Heart Failure/Congestive Heart Failure (4446); Valvular Insufficiency/ Regurgitation (4449); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 07/19/2019

Event Type  Injury  

Manufacturer Narrative

Medtronic has requested additional information pertaining to this reportable event.If additional reportable information is received, a supplemental report will be submitted.Select patient information cannot be included in regulatory report due to regional privacy regulations.Product analysis: the device remains implanted, therefore no product analysis can be performed.Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.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.

Event Description

Medtronic received information that approximately five years and two months following the implant of this transcatheter bioprosthetic valve, an echocardiogram showed trace central aortic regurgitation (ar).Approximately nine years and five months post-implant, an echocardiogram showed moderate central ar.Stable gradients were reported.Nine years and six months post-implant a non-medtronic valve was implanted valve-in-valve due to severe central ar.While in recovery following the procedure, the patient experienced symptoms of a left middle cerebral artery (mca) stroke.Intervention to remove the blood clot was performed.No additional adverse patient effects were reported.

Event Description

Medtronic received information that approximately five years and two months following the implant of this transcatheter bioprosthetic valve, an echocardiogram showed trace central aortic regurgitation (ar).Approximately nine years and five months post-implant, an echocardiogram showed moderate central ar.Stable gradients were reported.Nine years and six months post-implant a non-medtronic valve was implanted valve-in-valve due to severe central ar.While in recovery following the procedure, the patient experienced symptoms of a left middle cerebral artery (mca) stroke.Intervention to remove the blood clot was performed.No additional adverse patient effects were reported.Additional information was received that the stroke was confirmed with computed tomography (ct) imaging.Aphasia was noted with permanent impairment of slurred speech.Per the physician, the stroke was attributed to the valve replacement procedure and was caused by embolization of clot that occurred during the procedure.A thrombectomy was performed to remove the clot.It was reported that trace paravalvular leak (pvl) was present since the initial valve implant procedure until the recent admission with congestive heart failure (chf) and severe ar which was suspected to be due to a torn leaflet.

Manufacturer Narrative

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.

Manufacturer Narrative

Updated data: b5.Third paragraph added 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 that approximately five years and two months following the implant of this transcatheter bioprosthetic valve, an echocardiogram showed trace central aortic regurgitation (ar).Approximately nine years and five months post-implant, an echocardiogram showed moderate central ar.Stable gradients were reported.Nine years and six months post-implant a non-medtronic valve was implanted valve-in-valve due to severe central ar.While in recovery following the procedure, the patient experienced symptoms of a left middle cerebral artery stroke.Intervention to remove the blood clot was performed.No additional adverse patient effects were reported.Additional information was received that the stroke was confirmed with computed tomography imaging.Aphasia was noted with permanent impairment of slurred speech.Per the physician, the stroke was attributed to the valve replacement procedure and was caused by embolization of clot that occurred during the procedure.A thrombectomy was performed to remove the clot.It was reported that trace paravalvular leak was present since the initial valve implant procedure until the recent admission with congestive heart failure and severe ar which was suspected to be due to a torn leaflet.Additional information was received that there was no visible clot on the valve.

• 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: 18088052
• MDR Text Key: 327588328
• Report Number: 2025587-2023-04606
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P130021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/06/2016
• Device Model Number: MCS-P3-29-AOA
• Device Catalogue Number: MCS-P3-29-AOA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2023
• Date Device Manufactured: 02/19/2014
• 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; Hospitalization