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

Model Number 500FA19

Device Problems Gradient Increase (1270); Insufficient Information (3190)

Patient Problems Aneurysm (1708); Aortic Valve Stenosis (1717); No Information (3190)

Event Date 10/19/2018

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 16 years and 10 months post implant of this aortic mechanical valve, the valve was explanted and replaced with a bioprosthetic tissue valve.The reason for explant is unknown.No additional adverse patient effects were reported. .

Manufacturer Narrative

Medtronic received additional information that the valve was replaced due to stenosis and increased gradients.The patient also had an aneurysm on the proximal arch of the ascending aorta that was repaired during this case.The valve was replaced with a non-medtronic valve.No additional adverse patient effects were reported.  if information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: AORTIC FLEX
• 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: 8101530
• MDR Text Key: 128265445
• Report Number: 3008592544-2018-00053
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/15/2003
• Device Model Number: 500FA19
• Device Catalogue Number: 500FA19
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/27/2018
• Date Device Manufactured: 06/15/2000
• 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: 73 YR
• Patient Weight: 91