MAUDE Adverse Event Report: HEART VALVES SANTA ANA DIVISION COREVALVE 31MM AORTIC VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number MCS-P3-31-AOA

Device Problems Physical Resistance (2578); Device Operates Differently Than Expected (2913); Positioning Problem (3009)

Patient Problems Death (1802); Hemorrhage/Bleeding (1888)

Event Date 08/07/2014

Event Type  Death  

Event Description

Medtronic received information that during implant of this transcatheter bioprosthetic valve, the valve moved into the ventricle while attached to the delivery catheter system (dcs).An attempt was made to reposition the valve, but after it was released from the dcs it moved apically, which resulted in moderate to severe paravalvular leak (pvl).Implant of a second valve was attempted; however, it could not be delivered through the first valve due to a calcified sinotubular junction and ascending aorta, which was constraining the outflow portion of the valve and caused the second valve to get caught in the outflow struts.The second valve was removed, and the patient was placed on femoral-femoral bypass to stabilize their hemodynamics.The first valve was then snared and pulled up into its intended position.Post-dilation was performed, reducing the leak to a trace level.Closure of the access sites was initiated; however, the patient was not able to be taken off bypass successfully.The family directed that treatment be stopped and the patient expired.It was reported that the patient had poor left ventricular function and did not tolerate the procedure/pvl well.The official cause of death is unknown.An autopsy was not performed and the device was not explanted.

Manufacturer Narrative

The product remains implanted and therefore has not been returned to medtronic.A supplemental report will be filed when the investigation is completed.(b)(4).

Manufacturer Narrative

The device history record for valve was reviewed and showed that this device met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.The event description does not indicate a potential manufacturing issue.Numerous factors can affect dislodgement, such as complex patient anatomy, inadequate valve deployment, or incomplete detachment of valve from delivery catheter system (dcs).However, it is unclear whether the physician pulled on the dcs inadvertently or with intent to reposition, and the root cause of the dislodgement could not be concluded from the limited information available.Paravalvular leak can be caused by a variety of factors, including valve positioning, patient anatomy, or presence of pre-existing patient conditions.In this case the most likely cause for the pvl was due to positioning and a conclusive cause could not be determined from the limited information available, however, based on the implanting difficulties with the second valve it appears that there may have been patient anatomy issues that prevented valve placement.

Manufacturer Narrative

Corrected information: no eval explain code.

• Brand Name: COREVALVE 31MM AORTIC VALVE
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): HEART VALVES SANTA ANA 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: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 4045095
• MDR Text Key: 4803776
• Report Number: 2025587-2014-00611
• 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: Health Professional,Company Representative,company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/16/2014

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/26/2015
• Device Model Number: MCS-P3-31-AOA
• Device Catalogue Number: MCS-P3-31-AOA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/16/2014
• Initial Date FDA Received: 08/28/2014
• Supplement Dates Manufacturer Received: Not provided; 12/16/2014
• Supplement Dates FDA Received: 12/27/2014; 09/15/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/03/2014
• 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
• Treatment: (B)(4)
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 00084 YR