MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION COREVALVE 29MM AORTIC VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number MCS-P3-29-AOA-US

Device Problems Difficult To Position (1467); Premature Activation (1484); Unintended Movement (3026)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/06/2015

Event Type  Injury  

Event Description

Medtronic received information that during its positioning, this transcatheter bioprosthetic valve was deployed too high and moved from its targeted position.As the valve was being withdrawn, the tension created by the patient¿s ascending aortic arch against the delivery catheter system (dcs) opened the dcs capsule far enough for the valve¿s frame loops to release from the dcs tabs.The valve was deployed in the ascending aorta.A second valve was then successfully implanted.The physician reported that the malposition of the first valve was the result of the deployment attempt being initiated too high in the annulus.No adverse patient effects were reported.

Manufacturer Narrative

The valve remains implanted and therefore has not been returned to medtronic.There was no allegation against the dcs, which was discarded after the procedure.(b)(4).

Manufacturer Narrative

Conclusion: the reported clinical observation does not indicate a potential manufacturing issue.Potential factors that can influence a valve dislodgement include tension applied on the delivery catheter system (dcs) during positioning, calcification levels and compliance of the native anatomy, and a number of others.It should be noted that dislodgement complaints are typically not related to a device malfunction.This event does not allege a device malfunction occurred.In this case, during the implant of this transcatheter bioprosthetic valve, the valve was deployed too high and dislodged when at two-thirds deployment.Per the physician, deployment of the first valve had been initiated too high in the annulus.However, a conclusive root cause of the dislodgement could not be established from the information available.Per corevalve instructions for use (ifu), ¿once deployment is initiated, retrieval of the bioprosthesis from the patient (e.G., use of the catheter) is not recommended.Retrieval of a partially deployed valve using the catheter may cause mechanical failure of the delivery catheter system, aortic root damage, coronary artery damage, myocardial damage, vascular complications, prosthetic valve dysfunction (including device malposition), embolization, stroke, and/or emergent surgery.¿.

Manufacturer Narrative

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

• Brand Name: COREVALVE 29MM 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: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 4468423
• MDR Text Key: 17578211
• Report Number: 2025587-2015-00103
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 08/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/09/2016
• 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?: No
• Date Manufacturer Received: 08/07/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/22/2014
• 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
• Patient Outcome(s): Required Intervention