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

Model Number 305U223

Device Problem Gradient Increase (1270)

Patient Problems Chest Pain (1776); Dyspnea (1816); Thrombus (2101)

Event Date 03/11/2015

Event Type  Injury  

Event Description

Medtronic received information via a patient advocate who reported approximately seventeen months post implant of this bioprosthetic valve, the valve was explanted after an echocardiogram indicated moderately severe prosthetic aortic dysfunction and increased gradient measurements of 25-30 mmhg.It was also reported that the patient had been admitted to the hospital several times since the implant due to shortness of breath and chest pain that had been unsuccessfully treated with medications.It was determined a surgical intervention was necessary as the physician suspected severe aortic stenosis based on echocardiogram.However, during the surgical intervention, the physician found laminated thrombi in 2 of the 3 sinuses and no aortic stenosis.The surgeon decided to replace the valve since the valve was exposed.A larger non-medtronic valve was successfully implanted.Per the physician, there were no performance or product quality issues of the valve.The valve was discarded after hospital analysis.No further adverse patient effects were reported.

Manufacturer Narrative

Product analysis: the product remains was discarded by the customer, therefore no product analysis can be performed.Conclusion: without return of the product, no definitive conclusions could be drawn regarding the clinical observation.Should additional information become available, a supplemental report will be submitted.(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: 4765156
• MDR Text Key: 17932690
• Report Number: 2025587-2015-00541
• 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: Other,Health Professional,Company Representative,company representati
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2018
• Device Model Number: 305U223
• Device Catalogue Number: 305U223
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/16/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/04/2013
• 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): Hospitalization; Required Intervention
• Patient Age: 00076 YR