MAUDE Adverse Event Report: MEDTRONIC, INC. MOSAIC ULTRA; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number 305

Device Problem Break (1069)

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

Event Date 07/09/2018

Event Type  malfunction  

Event Description

While suturing a valve into position, a suture broke when tied, which then caused concerns that it may or may not cause it to function properly, thus this one was removed and a new valve was placed into position.The valve was then sized for a 23 mm medtronic mosaic ultra aortic tissue valve.The sutures were placed.The valve was then seated and the sutures were tied.One of the valve sutures broke at this point and it was not possible to place extra sutures.The valve had to be removed and all pledgets taken out.It was decided to enlarge the aortic root because the 23 mm aortic valve was very tight.The aortotomy incision was carried down toward the commissure between the left coronary and the noncoronary cusp.The commissure was divided, and the incision carried down toward the anterior leaflet of the mitral valve.A 34 mm hemashield patch was obtained and a patch was cut from the graft to be used for the enlargement.The aortic root was then enlarged using 4-0 prolene suture and then a 5-0 prolene suture as a second layer.A new 23 mm medtronic mosaic ultra valve was obtained because i was not sure whether the old valve was damaged during the removal.The valve sutures were placed.The valve was then seated and the sutures were tied.The patient was then rewarmed.The aortotomy incision was then closed using the hemashield patch and 4-0 prolene running sutures followed by 5-0 prolene running sutures.Before the complete closure of the aortotomy as much of the air was evacuated from the left heart as possible and once the aortotomy incision was closed, the crossclamp was then removed while aspirating the air out of the ascending aorta.

• Brand Name: MOSAIC ULTRA
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): MEDTRONIC, INC.; 1851 east deere ave.; santa ana CA 92705
• MDR Report Key: 9738874
• MDR Text Key: 180398038
• Report Number: 9738874
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/15/2020,01/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 305
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/15/2020
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 24090 DA
• Patient Weight: 76