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

Model Number	MCS-P3-31-AOA-US
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Bradycardia (1751); Non specific EKG/ECG Changes (1817); Low Blood Pressure/ Hypotension (1914); Ventricular Fibrillation (2130)
Date of Event	07/19/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Continuation of d10: product id: dcs-c4-18fr; product lot/serial number (b)(6); product type: delivery catheter system; implant date: na; explant date: na product id: cls-3000-18fr; product lot/serial number (b)(6); product type: compression loading system; implant date: na; explant date na 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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Medtronic received information that during the implant of this transcatheter bioprosthetic valve, ventricular fibrillation was reported and cardioversion was performed once.Following the valve implant procedure, left bundle branch block (lbbb) and sinus bradycardia were noted.A temporary pacing wire was placed and medication was adjusted.Hypotension was reported due to volume depletion and pressors were prescribed.No further adverse patient effects were reported.Additional information was reported that no treatment was provided for the lbbb.Per the physician, the lbbb was related to the valve and valve implant procedure.Approximately six months following onset, the lbbb resolved, without sequelae.Additional information was reported that a permanent pacemaker was implanted three days following the implant of the valve for bradycardia.Bradycardia resolved with no sequelae one day following the implant of the permanent pacemaker.Per the physician, the bradycardia event was related to the valve and the valve implant procedure.

• 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: 22915018
• Report Number: 9617601-2025-01210
• Device Sequence Number: 9055169
• Product Code: NPT
• UDI-Device Identifier: 00643169448551
• UDI-Public: (01)00643169448551(17)180126
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P130021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/28/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/26/2018
• Device Model Number: MCS-P3-31-AOA-US
• Device Catalogue Number: MCS-P3-31-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: 08/01/2025
• Initial Report FDA Received Date: 08/28/2025
• Date Device Manufactured: 02/10/2016
• 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: Life Threatening; Required Intervention
• Patient Age: 83 YR
• Patient Sex: Female
• Patient Weight: 76 KG