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

Model Number MCS-P3-29-AOA

Device Problems Incomplete Coaptation (2507); Device Operates Differently Than Expected (2913)

Patient Problem Regurgitation (2259)

Event Date 07/24/2014

Event Type  Injury  

Event Description

Medtronic received information that severe central regurgitation was noted following the initial implant of this transcatheter bioprosthetic valve.Post-implant dilatation performed with a 26 millimeter balloon did not improve the regurgitation.A second transcatheter bioprosthetic valve of the same model and size was implanted valve-in-valve, resulting in a mild paravalvular leak.No additional intervention or treatment was performed.No adverse patient effects were reported.It was questioned whether the valve may have had one or more defective or malfunctioning leaflets that caused or contributed to the central regurgitation.

Manufacturer Narrative

The product remains implanted and therefore has not been returned to medtronic.It was reported that visual images from the procedure would be submitted for analysis.A supplemental report will be filed when the investigation is completed.(b)(4).

Manufacturer Narrative

To date, procedural images have not been provided for analysis/review.The device history record was reviewed and showed that this valve met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.A conclusive cause for the report of severe regurgitation could not be determined from the limited information available.The reported information does not indicate a potential manufacturing issue.The mild paravalvular leak that was the outcome of the valve-in-valve implant is generally deemed an acceptable residual condition.Paravalvular leak can be caused by a variety of factors, including valve positioning, patient anatomy, or the presence of pre-existing patient conditions.

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: 4054953
• MDR Text Key: 4865275
• Report Number: 2025587-2014-00627
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P130021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/03/2014

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: 06/07/2015
• Device Model Number: MCS-P3-29-AOA
• Device Catalogue Number: MCS-P3-29-AOA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/03/2014
• Initial Date FDA Received: 09/03/2014
• Supplement Dates Manufacturer Received: Not provided; 11/03/2014
• Supplement Dates FDA Received: 11/05/2014; 09/15/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/28/2013
• 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-P3-29-AOA, B100111
• Patient Outcome(s): Required Intervention
• Patient Age: 00090 YR