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

Model Number 505DA18

Device Problem Insufficient Information (3190)

Patient Problem Occlusion (1984)

Event Date 04/15/2019

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 18 mm aortic mechanical valve, the valve was explanted and replaced with a 16 mm mechanical valve (manufacturer unknown).It was reported that post implant there was a coronary occlusion identified when retrograde cardioplegia was infused to check the status of the coronary circulation.The surgeon reported that the cause of the occlusion was the influence of a non-medtronic mitral mechanical valve and small sinus of valsalva (sov).The surgeon also reported that the patient had a rigid non-coronary cusp (ncc) which prevented extension of the aortic annulus.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: 8596098
• MDR Text Key: 144584779
• Report Number: 3008592544-2019-00019
• 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: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/09/2019

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 Expiration Date: 05/30/2024
• Device Model Number: 505DA18
• Device Catalogue Number: 505DA18
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/19/2019
• Initial Date FDA Received: 05/09/2019
• Date Device Manufactured: 05/30/2017
• 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: 78 YR