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

Model Number 305U223

Device Problems Material Separation (1562); Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190); No Code Available (3191)

Event Date 07/09/2018

Event Type  Injury  

Manufacturer Narrative

Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that immediately after implant of this 23mm aortic bioprosthetic valve, the valve was explanted and replaced with a valve of the same size and model.The reason for explant is unknown.No additional adverse patient effects were reported. .

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Medtronic received additional information from a user facility medwatch that while suturing the valve into position, a suture broke when tied, which caused concern that the valve may not function properly, thus it was explanted.The valve was sized for a 23mm valve and following the removal of the vale, the surgeon decided to enlarge the aortic root because the 23mm valve was tight.The aortic root was enlarged and a new 23mm valve of the same model was implanted.No additional adverse patient effects were reported.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 VALVE DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 7762309
• MDR Text Key: 116408563
• Report Number: 2025587-2018-02047
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00643169595019
• UDI-Public: 00643169595019
• Combination Product (y/n): N
• PMA/PMN Number: P990064
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 03/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/19/2022
• Device Model Number: 305U223
• Device Catalogue Number: 305U223
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/16/2018
• Initial Date FDA Received: 08/08/2018
• Supplement Dates Manufacturer Received: 08/08/2018; 02/25/2020
• Supplement Dates FDA Received: 10/02/2018; 03/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Weight: 76