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

Model Number 305019

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Aortic Insufficiency (1715)

Event Date 10/16/2014

Event Type  Injury  

Manufacturer Narrative

Subsequently additional information was received correcting the initial report from the procedure.Following implant of another manufacturer's mitral ring, the patient's native aortic valve retracted (not an unidentified medtronic bioprosthetic valve as orginally reported).Due the effect on the patient's native valve, the native valve was excised and a medtronic bioprosthetic tissue valve was implanted to successfully resolve the patient's condition with no adverse patient effects.(b)(4).

Event Description

Medtronic received information that an unidentified medtronic bioprosthetic aortic heart valve had been explanted due to aortic insu fficiency that was the result of the implant of another manufacturer¿s mitral repair ring.Following the implant of the mitral ring, the aortic valve began to retract.Both the ring and the valve were explanted and replaced.There were no issues with the valve, other than its performance being affected by the mitral ring implant.

Manufacturer Narrative

(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: 4242494
• MDR Text Key: 12577495
• Report Number: 2025587-2014-00875
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 305019
• Device Catalogue Number: 305019
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/21/2014
• Was Device Evaluated by Manufacturer?: No
• 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