MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION AORTIC AP; HEART-VALVE, MECHANICAL

Model Number 505DA18

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Obstruction/Occlusion (2422)

Event Date 04/28/2018

Event Type  Injury  

Manufacturer Narrative

Product analysis: upon receipt at medtronic's quality laboratory, visual examination revealed the valve did not have any evidence of impingement.Using a blue actuator to test leaflet movement, the leaflets moved without difficulty and both were intact with no evidence of damage.Both inflow and outflow valve hinge mechanisms were intact.The inflow and outflow orifices were intact with no evidence of damage.The valve was rinsed under tap water and it was verified that the carbon subassembly rotated in the sewing ring.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that following the implant of this mechanical valve, it was noted that the valve had occluded the coronary artery.The valve was explanted and replaced with a non-medtronic valve.No additional adverse patient effects were reported.

• Brand Name: AORTIC AP
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e. deere ave; santa ana CA 92705 5720
• Manufacturer (Section G): MEDTRONIC HEART VALVES DIVISION; 1851 e. deere ave; santa ana CA 92705 5720
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 7540746
• MDR Text Key: 109138542
• Report Number: 2025587-2018-01284
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P990046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/30/2021
• Device Model Number: 505DA18
• Device Catalogue Number: 505DA18
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/02/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/30/2016
• 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: 42 YR
• Patient Weight: 50