MAUDE Adverse Event Report: MEDTRONIC HEART VALVE DIVISION OPEN PIVOT AP360 HEART VALVE; HEART-VALVE, MECHANICAL

Model Number 505DM18

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Corneal Pannus (1447)

Event Date 01/22/2018

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 approximately one month post implant of this 18mm mechanical valve, the valve was explanted and replaced with a 16mm mechanical valve due to pannus formation.The surgeon suggested the pannus was caused by the patient's inability to take warfarin due to their age and was unable to measure the activated coagulation time for the patient.The surgeon indicated there was no problem with the mechanical valve.No additional adverse patient effects were reported. .

• Brand Name: OPEN PIVOT AP360 HEART VALVE
• 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: 7777911
• MDR Text Key: 116929762
• Report Number: 3008592544-2018-00026
• 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: Other
• Type of Report: Initial
• Report Date: 08/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 505DM18
• Device Catalogue Number: 505DM18
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/22/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 1 YR