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 Calcified (1077); Perivalvular Leak (1457); Central Regurgitation (4068)

Patient Problems Aortic Valve Stenosis (1717); Stroke/CVA (1770); Endocarditis (1834); Visual Impairment (2138); Dysphasia (2195); Numbness (2415); Confusion/ Disorientation (2553); Thrombosis/Thrombus (4440); Valvular Insufficiency/ Regurgitation (4449); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 05/22/2021

Event Type  Injury  

Manufacturer Narrative

This report is being submitted as part of a retrospective review and remediation per (b)(4).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 six years, nine months, one day following the implant of this transcatheter bioprosthetic valve ((b)(6)), the patient presented with a cerebral vascular accident (cva).Symptoms included confusion, left wrist, and perioral numbness.Examination showed stable vitals and the symptoms resolved upon admission.Neuro assessment showed no neuro motor or sensory deficit, and no dysarthria.A head computed tomography (ct) and chest x-ray were negative.The brain magnetic resonance imaging (mri) showed subacute infarction and subarachnoid blood.Transthoracic echocardiogram (tte) showed increased transvalvular aortic valve (av) velocity and mild to moderate transvalvular insufficiency.Abnormal av with rocking motion was noted.Tee identified mobile mass that was consistent with prosthetic aortic valve thrombus or vegetation.It was reported that the cva was likely due to the aortic valve vegetation.Blood cultures were negative; however, intravenous therapy (iv) antibiotics were administered, and endocarditis was noted.The cva was reported to be related to the valve and was noted to be resolved one day following onset.Eight days following presenting a tee showed severely thickened valve leaflets with moderate av stenosis, mobile strands on the valve, thickening of interventricular fibrosa and mild paravalvular leak (pvl).Six years, ten months, and twenty-six days following the implant of this valve, the patient again presented with a cva, with symptoms that included double vision and slurred speech.National institutes of health stroke scale (nihss) was a one upon presenting.The symptoms resolved within twenty-four hours.A head ct shows no acute process or evidence of ischemia.Mri shows a new right midbrain and cerebellar hemisphere infarct.A new embolic event was diagnosed.Tee showed moderate stenosis with mild to moderate ai and a 11 millimeter (mm) mobile structure.Av vegetation was not able to be ruled out.Blood cultures were negative, and iv medication was administered.A haemophilus species (hacek) organism was the presumed cause as the cultures were negative.The second cva was reported to be resolved approximately two weeks after onset.No additional adverse patient effects were reported.Additional information was reported that the mri showed minimal subacute hemorrhage.No additional adverse patient effects were reported.Additional information was reported that the seven-year follow-up echocardiogram showed leaflet calcification with decreased mobility and increased gradient.No treatment was provided.No additional adverse patient effects were reported.

Manufacturer Narrative

Previous report(s) in this series should have contained the following narrative text: "this report is being submitted as part of a retrospective review and remediation for capa 564121 per (b)(4)." 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.

• 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: 18913286
• MDR Text Key: 337771667
• Report Number: 2025587-2024-01691
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/03/2024

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 Expiration Date: 05/27/2015
• 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
• Initial Date Manufacturer Received: 09/01/2021
• Initial Date FDA Received: 03/15/2024
• Supplement Dates Manufacturer Received: 03/28/2024
• Supplement Dates FDA Received: 04/03/2024
• Date Device Manufactured: 06/04/2014
• 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): Life Threatening; Required Intervention; Disability
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 73 KG