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

Model Number 505D

Device Problem Escape (2931)

Patient Problem Aortic Regurgitation (1716)

Event Date 05/16/2018

Event Type  Injury  

Manufacturer Narrative

Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that 6 days post implant of this 22mm mechanical aortic valve, a transesophageal echocardiogram (tee) showed severe aortic regurgitation.Additionally, fluoroscopy and aortogram showed the same along with motion of a single leaflet visualized only, the other leaflet was not freely moving.As a result, the valve was explanted and replaced with another mechanical valve.The mechanical mitral valve also exhibited moderate regurgitation with no plans for intervention.No additional adverse patient effects were reported. .

• Brand Name: AORTIC AP
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): MEDTRONIC HEART VALVE DIVISION; 3800 annapolis lane; minneapolis MN 55447
• Manufacturer (Section G): MEDTRONIC HEART VALVE DIVISION; 3800 annapolis lane; minneapolis MN 55447
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 7573686
• MDR Text Key: 110228187
• Report Number: 3008592544-2018-00019
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• PMA/PMN Number: P990046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/25/2022
• Device Model Number: 505D
• Device Catalogue Number: 505DA22
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/16/2018
• Date Device Manufactured: 09/25/2017
• 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: 39 YR
• Patient Weight: 80