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

Model Number 505DA20

Device Problem Insufficient Information (3190)

Patient Problem Occlusion (1984)

Event Date 07/29/2019

Event Type  Injury  

Manufacturer Narrative

Product analysis: no product was returned.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 immediately following implant of this 20mm aortic mechanical valve, the valve was explanted and replaced with an 18 mm mechanical valve.It was reported that post implant there was a coronary occlusion due to the valve cuff.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: 8941561
• MDR Text Key: 155871287
• Report Number: 3008592544-2019-00038
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 505DA20
• Device Catalogue Number: 505DA20
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/19/2019
• Initial Date FDA Received: 08/28/2019
• Date Device Manufactured: 03/13/2018
• 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