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

Model Number 305C225

Device Problem Gradient Increase (1270)

Patient Problems Chest Pain (1776); Memory Loss/Impairment (1958); Dizziness (2194); Lethargy (2560)

Event Date 09/01/2014

Event Type  Injury  

Event Description

Medtronic received information that 27 months post implant of this bioprosthetic valve, the valve was explanted due to a high gradient (measurement at rest 57mmhg; at peak 97mmhg).The patient reported lethargy, shortness of breath, intermittent chest pain, dizziness, and short-term memory loss.At explant, no clear etiology of valvular disease could be identified.The valve was replaced with a mechanical valve.No adverse patient effects were reported; post-operative echocardiogram indicated normal left ventricular systolic function.

Manufacturer Narrative

The product has been returned and analysis is in progress.Upon completion of analysis, a supplemental report will be submitted.(b)(4).

Manufacturer Narrative

Upon receipt at medtronic¿s quality laboratory, a leaflet remnant was received with the valve for analysis.Explant damage was observed on the valve.The valve showed a brown discoloration, which may be associated with an unknown solution the valve was placed in following explant and/or desiccation due to the receipt condition.The leaflets appeared cut or torn.The valve was distorted in an oval shape.All leaflets appeared to have been excised for histopathology samples during explant.All existing leaflets were slightly stiff but flexible, except where visible host tissue extended on the outflow.Tears that appeared to have occurred during explant were observed on the inflow and outflow of all leaflets.The condition of the commissures could be determined due to explant damage.Remnants of brown thrombotic-appearing host tissue were observed on the outflow of the existing leaflets.Dark brown discoloration in the aortic wall adjacent to all leaflets was suggestive of prior hemorrhage or blood accumulation.Traces of pannus lined the se wing ring on the outflow and top of the left right stent post.Radiography showed no evidence of mineralization in the valve leaflets or commissures.Radiography showed trace mineralization on the outer edge of the sewing ring adjacent to the right non-coronary stent post.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 high gradient could have resulted in the thrombus on the cusp outflow that caused the immobile leaflet.High gradients due to immobile leaflets caused by thrombus are a known failure mode and are addressed in the current device risk management file.

Manufacturer Narrative

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 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: 4163831
• MDR Text Key: 4869363
• Report Number: 2025587-2014-00751
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P990064
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/02/2017
• Device Model Number: 305C225
• Device Catalogue Number: 305C225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/23/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2012
• 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: 00064 YR