MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION COREVALVE 26MM AORTIC VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number MCS-P3-26-AOA

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Congestive Heart Failure (1783); Regurgitation (2259)

Event Date 02/19/2012

Event Type  Death  

Manufacturer Narrative

Subsequently the clinical study site reported that the patient death was probably related to the device replacement procedure, and that valve replacement was performed due to a thrombus on the device¿s left coronary cusp.A supplemental report will be filed when the analysis/investigation is completed.(b)(4).

Event Description

Medtronic received information that approximately eleven months after the implant of this transcatheter bioprosthetic heart valve the patient exhibited acute chest pain, and moderate aortic regurgitation (ar) was observed via cardiac catheterization.A transesophageal echocardiogram (tee) 16 days later also documented moderate ar.An x-ray showed no acute pathology and an electrocardiogram (ecg) showed no changes.The chest pain was treated medically.There was no treatment or intervention for the ar, which was reported as continuing, and the device remained implanted.Approximately two months after the onset of the chest pain and ar, the patient presented with increasing congestive heart failure symptoms and was found to have significant prosthetic aortic insufficiency.This device was subsequently surgically explanted and another manufacturer¿s prosthetic valve was implanted.It was reported that the patient subsequently passed away five days after the reoperation due to right-sided heart failure (severe hypokinesis).Left ventricular function was normal, as observed via tee.The patient was initially treated intravenously with medications for the depressed rv function prior to the patient¿s family electing for the administration of only palliative care after there were no signs of hemodynamic improvement.No autopsy was performed.

Manufacturer Narrative

The product has been returned and analysis is in progress.Upon completion of analysis and investigation, a supplemental report will be submitted.(b)(4).

Manufacturer Narrative

Product analysis: upon receipt at medtronic's quality laboratory, the valve appears slightly distorted; oval shaped.All leaflets were stiff due to host tissue on the outflow.All leaflets appear intact.All commissures appear intact however host tissue overgrowth made it difficult to determine the exact condition.Glistening off white pannus lines the inflow, extending into and covering the inner lumen to the inflow margin of attachment and all inferior coaptive areas.Pannus remained attached to the outflow frame, along the outflow margin of attachment, to the tops of all commissures, extending partially along the free margins, showing possible restricted leaflet movement.Brown thrombotic appearing host tissue filled and stiffened all leaflets on the outflow.Radiography showed no stent fractures but a tiny remnant of mineralization along the outside of the skirt.Conclusion: post-implant occurrence of aortic regurgitation after an extended time period can be caused by a variety of factors, including changes to patient anatomy or pre-existing medical conditions, and the root cause could not be determined from the information provided.A number of factors can affect the creation of thrombus, including medications, peri-procedural injury, and pre-existing patient conditions, and its presence and rate of formation is largely dependent on patient condition.Both aortic regurgitation and thrombus are listed as known potential adverse effect in the ifu.Although a conclusive cause of the pannus and thrombus could not be determined, these are known failure modes for bioprosthetic heart valves, and are most likely a patient related condition.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: COREVALVE 26MM 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
• Manufacturer (Section G): MEDTRONIC STRUCTURAL HEART; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: mike gaffney ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635265629
• MDR Report Key: 3759335
• MDR Text Key: 11751414
• Report Number: 2025587-2014-00221
• 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,health professional,stu
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/28/2014

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
• Device Operator: Health Professional
• Device Expiration Date: 10/24/2013
• Device Model Number: MCS-P3-26-AOA
• Device Catalogue Number: MCS-P3-26-AOA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/28/2014
• Initial Date FDA Received: 04/18/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; 04/28/2014
• Supplement Dates FDA Received: 04/28/2014; 05/21/2014; 09/14/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/14/2012
• 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): Death; Required Intervention
• Patient Age: 00065 YR