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

Model Number 310C33

Device Problems Off-Label Use (1494); Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 09/19/2019

Event Type  Death  

Manufacturer Narrative

Product analysis: 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 one day post implant of this mitral bioprosthetic valve implanted in the tricuspid position, the patient died.The cause of death was not received.There was no evidence to suggest that the valve or its function contributed to the patient¿s death.It is unknown whether an autopsy was performed.

Manufacturer Narrative

Medtronic received additional information that the reason for the patient death was reported to be several unrelated underlying conditions.The physician confirmed that valve or the procedure were not a factor in the patients death.No autopsy was performed.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: 9236067
• MDR Text Key: 163701539
• Report Number: 2025587-2019-03264
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00643169594876
• UDI-Public: 00643169594876
• 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: 01/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/13/2023
• Device Model Number: 310C33
• Device Catalogue Number: 310C33
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 80 YR
• Patient Weight: 79