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

Model Number 305C25

Device Problems Torn Material (3024); Insufficient Information (3190)

Patient Problems Aortic Insufficiency (1715); Calcium Deposits/Calcification (1758); Prolapse (2475); No Information (3190)

Event Date 11/07/2013

Event Type  Injury  

Manufacturer Narrative

Without the return of the product, no definitive conclusion can be made regarding the clinical observation.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that 8 years 6 days post implant of this aortic bioprosthetic valve, the device was replaced due to unknown reasons.No additional adverse patient effects were reported. .

Manufacturer Narrative

Medtronic received additional information that 8 years 6 days post implant of this aortic bioprosthetic valve, the device was replaced a transesophageal echocardiogram (tee) was performed which demonstrated severe aortic prosthetic valve malfunction.It appeared that one of the leaflets prolapsed into the ventricle with resultant severe aortic insufficiency.The intraoperative findings revealed a significant amount of adhesion from the previous surgery.The ascending aorta and root were aneurysmally enlarged.Visualization of the valve revealed calcification of the leaflets with the tear of the leaflet at the non-coronary side and prolapsed into the ventricle.It was obvious there was calcium debrided off the undersurface of the anterior mitral leaflet at the time of the first surgery.The character of the ascending aorta was aneurysmal and the wall attenuated.The previously implanted valve was excised and the annulus was debrided of the additional pledget material and sized to fit a 25 mm prosthesis.The 25 mm aortic bioprosthetic valve was implanted and the patient was weaned off of cardiopulmonary bypass.The heart was then inspected with a transesophageal echocardiogram (tee) and satisfactory function was noted.No additional adverse patient effects were reported. if information is provided in the future, a supplemental report will be issued.

• Brand Name: MOSAIC
• 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 HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 6814695
• MDR Text Key: 83433811
• Report Number: 2025587-2017-01461
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00721902694752
• UDI-Public: 00721902694752
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/29/2010
• Device Model Number: 305C25
• Device Catalogue Number: 305C25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/28/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/29/2005
• 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: 74 YR
• Patient Weight: 94