MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION MOSAIC MITRAL BIOPROSTHETIC HEART VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number 310C

Device Problems Structural Problem (2506); Torn Material (3024)

Patient Problem Mitral Regurgitation (1964)

Event Date 02/03/2016

Event Type  Injury  

Manufacturer Narrative

Without the return of the product, no definitive conclusion can be made regarding the clinical observation.(b)(4).

Event Description

Medtronic received information that eleven months following implant of this bioprosthetic mitral valve, this valve was explanted and replaced due to moderate regurgitation resulting from a leaflet tear.No adverse patient effects were reported.

Manufacturer Narrative

Product analysis: upon receipt at medtronic¿s quality laboratory, the returned product specimen was visually examined.All leaflets appeared intact and were found to be slightly stiff but flexible.The flat appearance on the top of the non-coronary commissure and bias cloth showed possible signs of pannus overgrowth which leaves the non-coronary cusp in the open position possibly resulting with restricted leaflet movement.A portion of the free margin of the non-coronary cusp appeared to fold back on itself, resting against the inner outflow rail.There was no evidence of a tear or damage on the leaflets.All commissures appeared to be intact.Remnants of pannus remained attached to the sewing ring on the inflow and outflow with traces on all stent posts.An unknown amount of pannus appears to have been removed on the inflow and outflow during explant.Radiography testing showed no evidence of mineralization in the valve and/or host tissue.Conclusion: the device history record was reviewed and showed that this product met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.Based on the received information and the returned product analysis, the root cause to the reported regurgitation can be most likely attributed to the leaflet not coapting properly, secondary to the observed pannus overgrowth.Pannus overgrowth is associated with surgical valve replacement due to patient interaction and/or healing response with the surgical valve.

Manufacturer Narrative

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

• Brand Name: MOSAIC MITRAL BIOPROSTHETIC HEART VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC STRUCTURAL HEART; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 5457471
• MDR Text Key: 38962618
• Report Number: 2025587-2016-00229
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P990064
• 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: 07/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/12/2018
• Device Model Number: 310C
• Device Catalogue Number: 310C31
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/23/2013
• 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 Weight: 80