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

Model Number 501DA16

Device Problem Insufficient Information (3190)

Patient Problems Aortic Valve Stenosis (1717); Thrombosis (2100)

Event Date 12/30/2014

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 from the patient that 9 years and 3 months post implant of this mechanical valve, the valve was explanted and replaced with a non-medtronic valve due to aortic stenosis.The patient reported that the valve was causing "clotting".No additional adverse patient effects were reported.The operative report indicated the patient had a permanent pacemaker implanted.It is unknown when or why the permanent pacemaker was implanted.

• Brand Name: AORTIC AP
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 3800 annapolis lane; minneapolis MN 55447
• Manufacturer (Section G): MEDTRONIC HEART VALVES DIVISION; 3800 annapolis lane; minneapolis MN 55447
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 8445015
• MDR Text Key: 139597242
• Report Number: 3008592544-2019-00013
• 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: company representative,consum
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 501DA16
• Device Catalogue Number: 501DA16
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/22/2019
• 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: 65 YR