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

Model Number 500FA19

Device Problems Unintended System Motion (1430); Structural Problem (2506); Unintended Movement (3026)

Patient Problems Host-Tissue Reaction (1297); Corneal Pannus (1447); Failure of Implant (1924)

Event Date 06/19/2018

Event Type  Injury  

Manufacturer Narrative

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 20 years post implant of this 19mm mechanical valve, the valve was explanted and replaced with a non-medtronic 23mm mechanical valve.The valve was explanted due to improper leaflet motion caused by subvalvular pannus formation.No additional adverse patient effects were reported. .

Manufacturer Narrative

Product analysis: upon receipt at medtronic¿s quality laboratory, visual inspection revealed the valve was returned with both leaflets intact and in the closed position with no evidence of damage.Both inflow and outflow valve hinge mechanisms were intact.The inflow and outflow orifices were intact with no evidence of damage.Tan glistening pannus was covering the sewing ring on the inflow and outflow extending slightly over the inflow and outflow orifice.An unknown amount of pannus appears to have been removed on the inflow and outflow during explant.Radiologic evaluation revealed no calcification on the leaflets.Conclusion: reduced performance of the valve is attributed to host tissue overgrowth.This finding is generally considered a patient -related condition.Additional information was received that this mechanical valve was replaced after 20 years and 3 months.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Added expiration date.Added device manufacture date.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 VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 7683114
• MDR Text Key: 113821732
• Report Number: 2025587-2018-01743
• 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,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/03/2002
• Device Model Number: 500FA19
• Device Catalogue Number: 500FA19
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/03/1997
• 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: 45 YR
• Patient Weight: 42