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

Model Number LXA

Device Problems Gradient Increase (1270); Material Integrity Problem (2978)

Patient Problems Death (1802); Failure of Implant (1924)

Event Date 01/14/2014

Event Type  Other  

Event Description

The mfr was notified on (b)(4) 2014 with a email from the hosp that of a mitroflow valve (lxa size 19) that was explanted after 1 year and 7 months due a reported high gradient secondary to an early structural valve deterioration in a young pt.On (b)(6) 2014, on the journal "circulation: the following article was published "accelerated degeneration of a bovine pericardial bioprosthetic aortic valve in children and young adults".On the list of pts that received a mitroflow valve and experimented the mitroflow explant, the mfr identified that the pt died after the explantation of the mitroflow valve.No details of the cause of death were provided.

Manufacturer Narrative

Device eval by mfr: sorin received the explanted valve, the investigation is still ongoing.Eval, 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.Results = no definitive results at this time.No conclusion can be drawn at this time as the histological analysis is still ongoing.Corrected date: the following boxes were modified for correction.

• Brand Name: MITROFLOW AORTIC PERICARDIAL HEART VALVE
• Type of Device: TISSUE, HEART VALVE
• Manufacturer (Section D): SORIN GROUP CANADA INC.; burnaby, bc ; CA
• Manufacturer (Section G): SORIN GROUP CANADA INC.; 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: 4575501
• MDR Text Key: 5560547
• Report Number: 3004478276-2014-00006
• 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: Foreign,Literature,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/14/2014

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: 02/28/2017
• Device Model Number: LXA
• Device Catalogue Number: LXA19
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/05/2014
• 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?: No
• Date Device Manufactured: 03/01/2012
• 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; Required Intervention
• Patient Age: 22 YR
• Patient Weight: 35