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

Model Number LXA

Device Problems Material Too Rigid or Stiff (1544); Material Rupture (1546); Incomplete Coaptation (2507); Insufficient Information (3190)

Patient Problem Aortic Insufficiency (1715)

Event Date 09/28/2015

Event Type  Injury  

Manufacturer Narrative

Device not returned to manufacturer yet.

Event Description

The manufacturer was notified on (b)(6) 2015 that a mitroflow valve will be explanted on (b)(6) 2015 after approximately 2.6 years.No further information provided.

Manufacturer Narrative

The complete manufacturing and material records for the subject valve were pulled and reviewed by quality control livanova (b)(4) corp.The results confirmed that this valve satisfied all material, visual, and performance standards required for a mitroflow aortic pericardial heart valve at the time of manufacture and release.Leaflets calcification, detected with visual, x-ray and histological analyses, caused stiffening and led to progressive valve stenosis.Pannus tissue overgrowth into the inflow lumen also contributed to valve stenosis.Aortic insufficiency likely resulted from leaflets tears and inadequate leaflet coaptation caused by calcification of the leaflets.There was no evidence of endocarditis in the returned valve.As reported in the scientific literature, structural dysfunction is the major cause of failure of bioprosthetic heart valves and the principal underlying pathologic process is cuspal calcification.Calcification can also cause stenosis due to cuspal stiffening.Calcific deposits are usually localized to cuspal tissue (intrinsic calcification).It is possible that the patient¿s clinical history and risk factors may have contributed to the structural valve deterioration observed in this mitroflow valve.However, little clinical history was provided.Corrected data: outcomes attributed to adverse event, corrected data: initial mdr inadvertently omitted to check the box that required intervention to prevent a permanent impairment/damage was necessary.Device availability, corrected data: the initial mdr failed to report that the device was received on 10/15/2015, which was prior to the initial submission of the mdr.

• Brand Name: MITROFLOW AORTIC PERICARDIAL HEART VALVE
• Type of Device: TISSUE HEART VALVE
• Manufacturer (Section D): SORIN GROUP CANADA INC.; 5005 north fraser way; burnaby, bc V5J 5 M1; CA V5J 5M1
• Manufacturer (Section G): SORIN GROUP CANADA INC.; 5005 north fraser way; burnaby,
• Manufacturer Contact: francesca crovato ; 5005 north fraser way; burnaby, bc ; 4125696
• MDR Report Key: 5156271
• MDR Text Key: 28493625
• Report Number: 3004478276-2015-00050
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P060038/S002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Nurse
• Type of Report: Followup
• Report Date: 02/09/2017

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: Physician
• Device Expiration Date: 03/31/2015
• Device Model Number: LXA
• Device Catalogue Number: LXA19
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/16/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2010
• 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: 74 YR