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

Model Number MCS-P3-3143

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Death (1802)

Event Date 07/07/2014

Event Type  Injury  

Event Description

Medtronic received information that this was the first of three transcatheter bioprosthetic valves implanted in a patient.One week after the implant of this device, two additional valves of the same size were implanted, according to a note written on a patient/implanted device registration card returned by a family member.The family member also reported the patient died ten days following the second procedure, and alleged that the death was due to a cardiologist¿s error in implanting this valve and poor blood flow following implant of the valve.It was not reported why the additional valves were implanted or if there was an allegation or evidence of those valves malfunctioning.

Manufacturer Narrative

Additional information is being sought.It is not known if the devices remain implanted.Separate reports have been filed on the other two valves.A search of medtronic¿s database shows no previous reports and no returned devices at the time of this report.A supplemental report will be filed if additional information is received or when the investigation is completed.(b)(4).

Manufacturer Narrative

Additional information was received that this valve was implanted low, resulting in moderate/severe aortic insufficiency.Seven days post-operative two additional valves ((b)(4)) were implanted; the first valve was implanted too high, so a second valve was implanted in the optimal position.Additional information is being sought.A supplemental report will be filed if additional information is received or when the investigation is completed.(b)(4).

Manufacturer Narrative

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.Inaccurate delivery is often influenced by patient anatomy and user technique, but a root cause of the low implant depth for this device could not be determined from the available information.The cause of death was not received, an autopsy was not performed, and the device was not returned for analysis; the allegation of the patient¿s family could not be confirmed or refuted based on the available information.

Manufacturer Narrative

No eval explain code.A good faith effort will be made to obtain the applicable information relevant to the report.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: 4129358
• MDR Text Key: 4797091
• Report Number: 2025587-2014-00710
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• PMA/PMN Number: P130021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,foreign,other
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/08/2015

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: 07/16/2014
• Device Model Number: MCS-P3-3143
• Device Catalogue Number: MCS-P3-3143
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/08/2015
• Initial Date FDA Received: 09/30/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; 01/08/2015
• Supplement Dates FDA Received: 10/02/2014; 02/02/2015; 09/15/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/14/2013
• 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
• Patient Outcome(s): Death; Hospitalization; Required Intervention
• Patient Age: 00091 YR
• Patient Weight: 64