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

Model Number	MCS-P3-31-AOA-US
Medical Device Problem Code	Device Stenosis (4066)
Health Effect - Clinical Codes	Aortic Valve Stenosis (1717); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2024
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
Medtronic received information that 7 years 12 months following the implant of this transcatheter bioprosthetic valve, severe valvular stenosis was observed.Subsequently the valve was explanted and a 25 millimeter (mm) non-medtronic surgical valve (intuity) was implanted to relieve the stenosis.No additional adverse patient effects were reported.
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
Additional information was received that the valve was explanted approximately eight years post valve implant.
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.
Additional Manufacturer Narrative
Product analysis: upon receipt at medtronic¿s quality laboratory, the device was received inside a jar fully submerged in clear solution.Visual inspection shows evidence of damage on the frame.Host tissue was observed on the frame and skirt.As received, all leaflets appeared to be in a closed position with leaflet misalignment noted between leaflets 2-3 and leaflet 1.Leaflets 1 and 2 were immobile.Limited leaflet mobility was noted on leaflet 3.Restricted leaflet movement appear to be associated with the extensive calcification observed on all leaflets.Extensive calcification nodules were found on the inflow and outflow of leaflet 1.Tissue deterioration due to visible calcification was observed on the superior coaptive junction of commissure 1-2.Extensive calcification was found on the belly, margin of attachment and free margin of leaflet 2.Leaflet deterioration, resulting in a hole, was noted on the margin of attachment of leaflet 2.Calcification nodules were found on the inflow and outflow of leaflet 3.Leaflet deterioration was noted on the outflow margin of attachment of leaflet 3, one area resulting in a small hole adjacent to commissure 3-1.Additional leaflet deterioration was found on the inferior coaptive area between leaflets 3 and 2.Tissue deterioration found on all leaflets appear to be associated with visible calcification.Commissure 3-1 was slightly stiff with surrounding tissue visibly textured.A layer of off-white pannus fully encapsulated commissure 1-2, leaflet deterioration noted adjacent to the commissure.Commissure 2-3 was notably stiff, possibly associated with visible calcification on the commissure.Thick, glistening off-white pannus adhered to the inflow crowns of the valve, extending into the inner lumen.Remnants of glistening pannus remained attached to the outer aspect of the valve and outflow frame.An unknown amount of pannus may have been removed during explant.Broken sutures were noted on the valve skirt below the inferior coaptive areas of commissure 2-3 and commissure 3-1.A bent strut was noted on the outflow frame, adjacent to commissure 1-2.Three frame struts were damaged (cut); one paddle near commissure 2-3 and two struts near commissure 3-1.The ends appeared jagged with an angled, pointy appearance.It is possible the damages were associated with the explant procedure.Radiography revealed calcification on all leaflets, commissural areas and outer wall.Radiography confirmed the observed frame damages (cuts); no other frame damages were shown.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 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: 19077050
• Report Number: 2025587-2024-02193
• Device Sequence Number: 17649840
• Product Code: NPT
• UDI-Device Identifier: 00643169448551
• UDI-Public: 00643169448551
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P130021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/29/2024

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?: Yes
• 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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2024
• Supplement Date Received by Manufacturer: 04/18/2024; 08/26/2024; 08/29/2024
• Initial Report FDA Received Date: 04/10/2024
• Supplement Report FDA Received Date: 04/26/2024; 08/28/2024; 08/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male