MAUDE Adverse Event Report: MEDTRONIC ATS MEDICAL AORTIC AP; HEART-VALVE, MECHANICAL

Model Number 505DA18

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Calcium Deposits/Calcification (1758); No Consequences Or Impact To Patient (2199)

Event Date 02/05/2014

Event Type  Injury  

Event Description

Medtronic received information that during the implant of this mechanical valve, the physician did not feel the valve was seated as expected due to a heavily calcified ring and irregular patient anatomy.After the valve was sutured down the physician chose to remove the device and replace it with another valve.There were no patient complications or alleged malfunction of the device.

Manufacturer Narrative

The valve was discarded by the explanting facility.The investigation is in progress.Upon completion of investigation, a supplemental report will be submitted.(b)(4).

Manufacturer Narrative

It was reported that the physician did not feel the valve was seated as expected due to a heavily calcified ring and irregular patient anatomy, and there were no patient complications.A device history record review was not conducted as the information received does not suggest a potential manufacturing issue.The available evidence indicates a patient anatomy issues resulted in the clinical observation.

Manufacturer Narrative

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

• Brand Name: AORTIC AP
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): MEDTRONIC ATS MEDICAL; 3905 annapolis lane north; minneapolis MN 55447
• 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: 3654130
• MDR Text Key: 4286876
• Report Number: 2134151-2014-00006
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P990046
• 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: 05/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/13/2015
• Device Model Number: 505DA18
• Device Catalogue Number: 505DA18
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/06/2014
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Age: 00071 YR