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

Model Number 305U225

Device Problem Structural Problem (2506)

Patient Problem Thrombus (2101)

Event Date 11/18/2014

Event Type  Injury  

Event Description

Medtronic received information that this bioprosthetic aortic heart valve was explanted three years after its implant due to a large thrombus below the valve.The valve was replaced with another bioprosthetic valve.Prior to the explant, it was suspected that the patient had mitral valve endocarditis and an abscess, and cultures were collected; however, upon device explant there was no vegetation or abscess found.A chest computed tomography angiography confirmed there was no abscess present.No endocarditis was present.No subsequent adverse patient effects were reported.

Manufacturer Narrative

The explanted device was sent to the facility¿s pathology department.It was not known if the device would be submitted to medtronic for analysis.(b)(4).

Manufacturer Narrative

Conclusion: the product has not been returned for analysis.Without the return of the valve, a root cause for the clinical observation cannot be determined.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.

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): HEART VALVES SANTA ANA; 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: 4385121
• MDR Text Key: 5365058
• Report Number: 2025587-2015-00033
• 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,company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/26/2016
• Device Model Number: 305U225
• Device Catalogue Number: 305U225
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/22/2011
• 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