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

Model Number 305

Device Problems Gradient Increase (1270); Structural Problem (2506); Material Distortion (2977)

Patient Problems Corneal Pannus (1447); Aortic Regurgitation (1716); Aortic Valve Stenosis (1717); Calcium Deposits/Calcification (1758); Cusp Tear (2656)

Event Date 09/28/2017

Event Type  Injury  

Manufacturer Narrative

The product has been returned and analysis is in progress.Upon completion of analysis, a supplemental report will be submitted.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that 11 years post implant of this aortic bioprosthetic valve, echocardiogram showed stenosis, regurgitation, elevated gradients and a leaflet tear.The valve was explanted and replaced with a non-medtronic valve.No additional adverse patient effects were reported.

Manufacturer Narrative

Product analysis: upon receipt at medtronic¿s quality laboratory, visual inspection showed the valve was slightly distorted; oval shaped.The sewing ring appeared to have been cut and/or removed during explant exposing the stent.All leaflets were in the closed position however, due to calcification, the free margins and part of the leaflet lunula had deteriorated, creating a gap at the point of coaptation.All leaflets were stiff but slightly flexible except where visible calcification and pannus extended on the inflow and outflow.Tissue deterioration due to visible calcification was observed on all leaflets and on all commissures.There was no evidence of commissure dehiscence.Pannus on the inflow extended from the sewing ring to the base stitching encroaching 1 to 6mm onto the left and non-coronary cusps and into all inferior coaptive areas.Thick pannus was observed across the middle of the right cusp (inflow).The observed pannus contributed to the reduced inflow orifice area.Extrinsic calcification was noted on the existing cusps.An unknown amount of pannus appeared to have been removed during explant.Radiography revealed calcification in all leaflets and commissures.Reduced performance of the valve is attributed to host tissue overgrowth.This finding is generally considered a patient-related condition.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Added serial number.Added expiration date.Added unique identifier (udi).Added device manufacture date.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MOSAIC AORTIC BIOPROSTHETIC HEART VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): MEDTRONIC HEART VALVE DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVE 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: 7006303
• MDR Text Key: 91232042
• Report Number: 2025587-2017-02044
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 11/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/26/2011
• Device Model Number: 305
• Device Catalogue Number: 305-29
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2006
• 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: 57 YR