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

Model Number 310C25

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Rupture (2208); Blood Loss (2597)

Event Date 05/27/2020

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 this patient underwent surgery to replace a previously implanted mitral valve bioprosthesis which had developed paravalvular leak (pvl).During the procedure, an unknown manufacturer's mitral valve was implanted and found to be competent.The patient was weaned off of cardiopulmonary bypass (cpb) and, upon inspection prior to chest closure, bleeding was observed from the posterior side of the heart.The patient was put back on cpb.It was observed that there was atrio-ventricular (av) disruption with blood emanating from the av groove.The previously placed mitral valve was then removed, this 25mm medtronic bioprosthetic valve was placed, and a pericardial patch was used to reconstruct the posterior annulus.Upon attempted weaning from cpb a second time, the right ventricle was not functioning normally.It was reported that this was possibly due to an injured right coronary artery.An additional repair attempt was made with a vein graft and an intra aortic balloon pump was placed.After the multiple repair attempts, it was reported the heart was extremely compromised and the patient passed away during the procedure.There was no evidence to suggest that the medtronic valve or its function contributed to the patient¿s death.It is unknown whether an autopsy was performed.

• 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
• 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: 10319873
• MDR Text Key: 200220170
• Report Number: 2025587-2020-02336
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00643169594838
• UDI-Public: 00643169594838
• 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
• Report Date: 07/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 310C25
• Device Catalogue Number: 310C25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/24/2020
• Date Device Manufactured: 01/15/2020
• 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): Death
• Patient Age: 77 YR