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

Model Number 12A

Device Problem Insufficient Information (3190)

Patient Problem Failure of Implant (1924)

Event Date 10/04/2013

Event Type  Other  

Event Description

The mfr was notified on (b)(6) 2013 that mitroflow valve (lxa size 21) was explanted after 4.6 years via hospital (b)(4).The surgeon believes the failure has both product and pt factors involved.On (b)(6) 2014, the hospital provided to the mfr clinical history info.

Manufacturer Narrative

Method: the results of the device history record review confirmed the device met all material, dimensional, and performance requirements at the time of mfr and release.

• Brand Name: MITROFLOW AORTIC PERICARDIAL HEART VALVE
• Type of Device: TISSUE, HEART VALVE
• Manufacturer (Section D): SORIN GROUP CANADA INC.; burnaby, british columbia ; CA
• Manufacturer (Section G): SORIN GROUP CANADA INC., MITROFLOW DIV; 5005 north fraser way; burnaby, bc V5J 5M1; CA V5J 5M1
• Manufacturer Contact: francesca crovato ; 5005 north fraser way; burnaby, bc V5J 5-M1 ; CA V5J 5M1 ; 4125696
• MDR Report Key: 4575499
• MDR Text Key: 5549948
• Report Number: 3004478276-2014-00029
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 12/31/2013
• Device Model Number: 12A
• Device Catalogue Number: 12A21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Device Manufactured: 01/01/2009
• 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): Required Intervention
• Patient Age: 80 YR