MAUDE Adverse Event Report: SORIN GROUP CANADA INC. MITROFLOW AORTIC PERICARDIAL HEART VALVE; TISSUE, HEART VALVE

Model Number LXA

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

Patient Problems Death (1802); Endocarditis (1834); Unspecified Infection (1930); Sepsis (2067)

Event Date 03/30/2014

Event Type  Death  

Event Description

The mfr was notified on 3 february 2014 that "physician called with report of endocarditis case.Pt is now in hosp and septic.Prior to this hospitalization, the pt had previous echo that showed small vegetations on the valve and was treated with 6 weeks of antibiotics and cultures were rechecked.Today, the pt is in the hosp again for a possible root abscess and is being treated with antibiotics.Due to his age, they do not want to reoperate and remove the valve at this time." on (b)(6) 2014, the hosp updated sorin that the pt died over the weekend of (b)(6) 2014.The surgeon indicated that he saw the autopsy.The valve was well incorporated, no svd but lots of vegetations on the underside of the leaflet.No cultures are back at this time.

Manufacturer Narrative

The device history record review did not indicate any mfg or material anomalies.A more thorough investigation could not be performed because the device will not be returned to the mfr and very limited info was provided on the pt's clinical states.Based on the available info, no further investigation can be performed.No conclusion can be drawn at this time as the device will not be returned to the mfr.

• Brand Name: MITROFLOW AORTIC PERICARDIAL HEART VALVE
• Type of Device: TISSUE, HEART VALVE
• Manufacturer (Section D): SORIN GROUP CANADA INC.; burnaby ; CA
• Manufacturer (Section G): SORIN GROUP CANADA INC.; 5005 north fraser way; burnaby 0000 V5J ; CA 0000V5J 5
• Manufacturer Contact: francesca crovato ; 5005 north fraser way; burnaby V5J 5-M1 ; CA V5J 5M1 ; 4125696
• MDR Report Key: 4283660
• MDR Text Key: 5225628
• Report Number: 3004478276-2014-00023
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P060038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/23/2014

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: Other
• Device Expiration Date: 01/31/2016
• Device Model Number: LXA
• Device Catalogue Number: LXA23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2011
• 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: 92 YR