MAUDE Adverse Event Report: MEDTRONIC MEXICO S. DE R.L. DE CV COREVALVE TRANSCATHETER AORTIC VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV

Model Number	MCS-P3-29-AOA-US
Medical Device Problem Codes	Perivalvular Leak (1457); Patient Device Interaction Problem (4001); Intravalvular regurgitation (4068)
Health Effect - Clinical Codes	Thrombosis/Thrombus (4440); Heart Failure/Congestive Heart Failure (4446); Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	01/22/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 or Problem Description
It was reported that 11 years following the implant of a transcatheter aortic valve, central regurgitation of unknown severity was identified.Subsequently, the patient was hospitalized and experienced symptoms of heart failure.
Event or Problem Description
Additional information was received which indicated that both central regurgitation and paravalvular leak were present.Additionally, it was noted that a "pouch" was visible on fluoroscopy.A thrombus was confirmed in the "pouch" area.A non-medtronic valve was implanted valve-in-valve (viv) as treatment of the failed valve.The thrombus was no longer present after the viv.
Additional Manufacturer Narrative
Updated data: b5.H6.Additional codes.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 or Problem Description
It was reported that 11 years following the implant of a transcatheter aortic valve, central regurgitation of unknown severity was identified.Subsequently, the patient was hospitalized and experienced symptoms of heart failure.Additional information was received which indicated that both central regurgitation and paravalvular leak were present.Additionally, it was noted that a "pouch" was visible on fluoroscopy.A thrombus was confirmed in the "pouch" area.A non-medtronic valve was implanted valve-in-valve (viv) as treatment of the failed valve.The thrombus was no longer present after the viv.Additional information was received that the severity of the both the central regurgitation and pvl combined was moderate.The "pouch" appeared to be due to the frame of the transcatheter valve rubbing against the aorta, and the thrombus was located in the pouched area.
Additional Manufacturer Narrative
Updated data: b5.Corrected data: h6.Additional codes.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
• Common Device Name: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
• Manufacturer (Section D): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer (Section G): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 24189249
• Report Number: 9617601-2026-00636
• Device Sequence Number: 13224377
• Product Code: NPT
• UDI-Device Identifier: 00643169448544
• UDI-Public: (01)00643169448544(17)161116
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P130021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/23/2026

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/16/2016
• Device Model Number: MCS-P3-29-AOA-US
• Device Catalogue Number: MCS-P3-29-AOA-US
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2026
• Supplement Date Received by Manufacturer: 01/27/2026; 03/14/2026
• Initial Report FDA Received Date: 01/27/2026
• Supplement Report FDA Received Date: 02/23/2026; 03/23/2026
• Date Device Manufactured: 11/27/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 80 KG