MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION RING ANNULOPLSTY TRICUSP CONTOUR 3D 26MM; RING, ANNULOPLASTY

Model Number 690R

Device Problem Material Deformation (2976)

Patient Problem Endocarditis (1834)

Event Date 07/09/2016

Event Type  Injury  

Manufacturer Narrative

This medwatch is being submitted to report the explant of the tricuspid ring, which was inadvertently submitted as a supplemental medwatch report 2025587-2016-01225.This medwatch is submitted as a correction to state that endocarditis was a suspected factor for the replacement of the tricuspid ring (serial number (b)(4)).The device has not been received for analysis.Without the receipt of the product, no definitive conclusion can be made regarding the clinical observation.Conclusion: at this time, there is no confirmation of infection.However, if confirmed, infection that occurs more than 12 months after the procedure are called late endocarditis and are largely community-acquired versus a result of the manufacturing process of the device.

Event Description

Medtronic received information that four years, three months post-implant of this tricuspid ring, upon opening of the right atrium, it was noticed that the patient had a thickening and fixed septal leaflet of the tricuspid valve, and what appeared to be a vegetation on the ring.The ring was detached on a portion of the septal leaflet due to what appeared to be vegetation.The septal and posterior leaflets had detached from the annulus.No culture results have been received.No other adverse patient effects were reported.

Manufacturer Narrative

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

• Brand Name: RING ANNULOPLSTY TRICUSP CONTOUR 3D 26MM
• Type of Device: RING, ANNULOPLASTY
• 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: 6015376
• MDR Text Key: 56910223
• Report Number: 2025587-2016-01599
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101212
• 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
• Report Date: 09/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/09/2016
• Device Model Number: 690R
• Device Catalogue Number: 690R26
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/20/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/26/2011
• 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: 30 YR
• Patient Weight: 54