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

Model Number 505DA22

Device Problem Incomplete Coaptation (2507)

Patient Problems Endocarditis (1834); Occlusion (1984)

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 an unknown duration post implant of this aortic mechanical valve, the patient developed endocarditis and underwent bentall operation.Then, an unknown duration post procedure, the patient underwent operation again due to occlusion of the coronary ostium.At that time, leaflet motion blocked for unknown reasons.The surgeon rotated the valve and then the leaflet issue was resolved.No additional adverse patient effects were reported. .

Manufacturer Narrative

Medtronic received additional information that this mechanical valve was implanted during the bentall operation.Therefore, the endocarditis infection occurred prior to implant of this mechanical valve and is not related to the device.No additional adverse patient effects were reported.  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 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: 7780247
• MDR Text Key: 116994201
• Report Number: 3008592544-2018-00028
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P990046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 505DA22
• Device Catalogue Number: 505DA22
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/01/2018
• 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