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

Model Number 305

Device Problem Calcified (1077)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/31/2014

Event Type  Injury  

Manufacturer Narrative

Product analysis: upon receipt at medtronic¿s quality laboratory, the non-coronary and left cusps were stiff due to host tissue on the outflow.The right cusp was slightly stiff but flexible.Tears on the tunica of all leaflets appeared to be due to the removal of host tissue during explant.All commissures were intact.Traces of pannus remained attached along the sewing ring on the inflow.A large remnant of glistening off white pannus remained attached to the sewing ring on the outflow adjacent to the left right stent post.Tan thrombotic appearing host tissue filled and stiffened the non-coronary and left cusps on the outflow.Traces of tan thrombotic appearing host tissue lined the right cusp on the outflow.Radiography showed no evidence of mineralization in the valve and/or host tissue.

Manufacturer Narrative

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.The transesophageal echocardiogram (tee) reports provided for medtronic over-read were limited in quantity and quality, with poor visualization of the bioprosthesis.A summary result of the echo over-read states that the bioprosthesis leaflets were not well visualized, but as shown they were normal, with no calcification evident on the available images.There was no aortic regurgitation.Based on the product analysis and echocardiogram over-read, the reported calcification and the reason for the explant cannot be confirmed.The observed thrombus that filled the cusps on the outflow could cause the immobile leaflets and compromised forward flow.Based on received communication, the patient does not have any past medical history of having blood disorders.A conclusive cause of the thrombus cannot be determined.Medtronic will continue to monitor field performance for similar events should they occur.

Event Description

Medtronic received information that calcification of this bioprosthetic aortic valve was observed six months after its implant.Subsequently, the valve was explanted and replaced with another manufacturer¿s device.No subsequent adverse patient effects were reported.

Manufacturer Narrative

It was reported that the device and a cine copy of the procedure will be returned for analysis.A supplemental report will be filed when the analysis/investigation is completed.(b)(4).

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: 4318610
• MDR Text Key: 12889965
• Report Number: 2025587-2014-01002
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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,Followup
• Report Date: 02/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/21/2018
• Device Model Number: 305
• Device Catalogue Number: 305U221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2013
• 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 Age: 00065 YR