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

Model Number 310C29

Device Problem Insufficient Information (3190)

Patient Problem Non specific EKG/ECG Changes (1817)

Event Date 07/23/2019

Event Type  Injury  

Manufacturer Narrative

Other relevant device(s) are: product id: 6 90r26, serial/lot #: (b)(4), ubd: 04-may-2024, udi#: (b)(4), pma# k101212.Product analysis: the products remain implanted; therefore, no product was returned.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 5 days post implant of this 29mm bioprosthetic mitral valve and this 26mm tricuspid annuloplasty ring, a permanent pacemaker was implanted in the patient.The reason for the permanent pacemaker implant was reported as incomplete atrio-ventricular (av) block.No additional adverse patient effects were reported.

Manufacturer Narrative

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

• Brand Name: MOSAIC MITRAL 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
• MDR Report Key: 8855817
• MDR Text Key: 153115404
• Report Number: 2025587-2019-02462
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00643169594852
• UDI-Public: 00643169594852
• 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
• Report Date: 08/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 310C29
• Device Catalogue Number: 310C29
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Weight: 88