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

Model Number MCS-P3-3143

Device Problems Perivalvular Leak (1457); Device Operates Differently Than Expected (2913)

Patient Problems Congestive Heart Failure (1783); Low Cardiac Output (2501)

Event Date 02/03/2014

Event Type  Injury  

Event Description

Medtronic received information that after the implant of an initial transcatheter bioprosthetic heart valve, the patient experienced a paravalvular leak (pvl) that varied between moderate and severe with a diminished ejection fraction.The patient had subsequently had a cardiac resynchronization defibrillator implanted to help with the ejection fraction, and at 17 months this device had been implanted valve-in-valve to address the pvl.One year after the valve-in-valve procedure, the pvl had again increased to a severe level, and an attempt was made to resolve the pvl with another manufacturer¿s plug.The condition remained ongoing, and one month later, another manufacturer¿s closure device was used to repair the pvl.The echocardiogram following that procedure showed a mild pvl and trace central regurgitation.No subsequent adverse patient effects were reported.

Manufacturer Narrative

The valves remain implanted.A supplemental report will be filed when the investigation is completed.(b)(4).

Manufacturer Narrative

Conclusion: the device history record was reviewed and showed that this product met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.The reported clinical observations do not indicate a potential manufacturing issue.Conduction disturbances are known potential adverse effects per corevalve instructions for use (ifu), and can be resolved with the implant of a permanent pacemaker with the risk-benefit ratio in favor of the percutaneous aortic valve (pav).In this case a cardiac resynchronization therapy defibrillator was implanted to improve ejection fraction.Post-implant occurrence of paravalvular leak (pvl) 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.

Manufacturer Narrative

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

• Brand Name: COREVALVE
• 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: 4192575
• MDR Text Key: 5162846
• Report Number: 2025587-2014-00782
• 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
• Report Date: 03/26/2015

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: 10/09/2013
• Device Model Number: MCS-P3-3143
• Device Catalogue Number: MCS-P3-3143
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/26/2015
• Initial Date FDA Received: 10/22/2014
• Supplement Dates Manufacturer Received: Not provided; 03/26/2015
• Supplement Dates FDA Received: 04/15/2015; 09/15/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/13/2012
• 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
• Treatment: MCS-P3-943, (B)(4)
• Patient Outcome(s): Required Intervention
• Patient Age: 00083 YR