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

Model Number 305U

Device Problem Gradient Increase (1270)

Patient Problems Corneal Pannus (1447); Aortic Valve Stenosis (1717); Dyspnea (1816); Fever (1858); Heart Failure (2206)

Event Date 06/29/2015

Event Type  Injury  

Event Description

Medtronic received information that 6 months post implant of this aortic bioprosthetic valve, it was explanted due to stenosis and a high mean gradient of 90mmhg.Prior to replacement surgery, fever, dyspnea, and heart failure due to high gradients were reported.Post-operation, the surgeon noted granulation and thickened tissue.No other adverse patient effects were reported.

Manufacturer Narrative

Product analysis: upon receipt at medtronic's quality laboratory, visual inspection of the valve indicated it was distorted (oval-shaped).All leaflets were slightly stiff but flexible, except where host tissue extended on the inflow and outflow.A small tear on the tunica of the left cusp along the inflow margin of attachment was determined to be associated with the removal of host tissue during explant.All commissures were intact.Remnants of glistening off-white pannus extended 1 to 2 mm onto the tunica of the right and non-coronary cusps, showing a possible reduced inflow orifice area.Traces of pannus remained attached to the sewing ring on the outflow.A remnant of pannus was observed on top of the right non-coronary stent post.Analysis determined that an unknown amount of pannus had been removed on the inflow and outflow during explant.Tan thrombotic-appearing host tissue filled and stiffened all cusps on the outflow.Radiography showed no evidence of mineralization in the valve and/or host tissue.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.The investigation is ongoing.A supplemental report will be filed upon completion of the investigation.(b)(4).

Manufacturer Narrative

Conclusion: based on the received information and the returned product analysis, the stenosis and high gradient are most likely caused by the pannus and valve distortion.Pannus overgrowth on the inflow extending several millimeters out onto the leaflets would have impaired the leaflet mobility.The impairment of leaflet mobility may have led to the thrombus formation on the outflow of the valve, causing the stenosis.Pannus overgrowth has been an inherent risk of surgical valve replacement.Exactly when and how the distortion occurred cannot be determined; however, per procedure each mosaic valve is inspected for distortion and this valve passed the inspection prior to release for distribution.Distortion of the annular ring can restrict the leaflets from fully opening and/or cause misalignment of leaflets during valve closure.

• Brand Name: MOSAIC AORTIC 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: 4918866
• MDR Text Key: 6012613
• Report Number: 2025587-2015-00749
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2019
• Device Model Number: 305U
• Device Catalogue Number: 305U223
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2014
• 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: 00061 YR