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

Model Number CRS

Device Problem Incomplete Coaptation (2507)

Patient Problems Calcium Deposits/Calcification (1758); Tachycardia (2095); Thrombosis/Thrombus (4440); Heart Failure/Congestive Heart Failure (4446)

Event Date 09/16/2020

Event Type  Injury  

Manufacturer Narrative

Citation: aktuerk et al.Leaflet thrombosis after valve-in-valve transcatheter aortic valve implantation: a case series.Eur heart j case rep.2020 sep 16;4(4):1-6.Doi: 10.1093/ehjcr/ytaa221.Ecollection 2020 aug.Earliest date of publish used for event date.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.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information via literature regarding leaflet thrombosis after valve-in-valve transcatheter aortic valve implantation (viv-tavi).Three cases were reported with confirmed leaflet thrombosis between (b)(6) 2018.All three patients had failed non-medtronic valves who underwent viv-tavi with a medtronic corevalve or evolut r bioprosthetic valve.No serial numbers were provided.Patient 2: a (b)(6)-year-old male patient with marfan syndrome was implanted with a 26-mm corevalve inside a non-medtronic surgical valve.Approximately three years later the patient presented with dyspnea, tachycardia at 98 bpm, and recurrent acute heart failure.Transthoracic echocardiography revealed severe biventricular dysfunction, thickened transcatheter valve leaflets, and peak/mean transvalvular gradients of 116/66 mmhg.Multidetector computerized tomography angiography suggested the transcatheter valve with reduced leaflet motion, moderate-sized thrombus, and degeneration with calcification.The patient was commenced on continuous intravenous heparin with no decrease in transvalvular gradients.The patient underwent emergency surgery to explant the transcatheter valve and replace it with a non-medtronic surgical valve.At excision the transcatheter valve was noted as degenerated with calcification and thrombosis.Eight days post-procedure the patient died as a result of an embolic stroke following decannulation of extra-corporeal mechanical support.No additional adverse patient effects or product performance issues were reported for this patient.

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.

• Brand Name: COREVALVE TRANSCATHETER AORTIC VALVE
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 11213005
• MDR Text Key: 228169001
• Report Number: 2025587-2021-00235
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• PMA/PMN Number: P130021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 01/21/2021

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
• Initial Date Manufacturer Received: 12/23/2020
• Initial Date FDA Received: 01/22/2021
• Supplement Dates Manufacturer Received: 12/23/2020
• Supplement Dates FDA Received: 01/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 25 YR