MAUDE Adverse Event Report: LIVANOVA CANADA CORP. MITROFLOW AORTIC PERICARDIAL HEART VALVE - MODEL DL; TISSUE HEART VALVE

Model Number DLA

Device Problems Calcified (1077); Material Too Rigid or Stiff (1544)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

It was reported that the patient's valve was explanted in 2016 after being implanted for less than 5 years.The device was returned and a gross examination was performed.

Manufacturer Narrative

Histological exam was sent to livanova on feb 17, 2017: histological analyses were performed on samples taken from leaflets b and c.In leaflets b and c, alizarin red s stain showed the presence of intrinsic calcifications.Pericardial folds were detected on leaflets b and c.In leaflets b and c, hematoxylin and eosin stain showed that the collagen bundles were disrupted and homogenated.The pericardium of leaflet a was slightly thicker than normal.Red blood cells were visible on leaflets b and c.Pericardial delaminations were detected on leaflets b and c.An amorphous tissue was visible inside fibrin deposits that were present on the mediastinic surface of leaflet c.In leaflets b and c, gram stain showed some gram + bacteria.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.

Manufacturer Narrative

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).Histological analysis identified gram positive bacteria on the pericardium but not inside the pericardium.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.

• Brand Name: MITROFLOW AORTIC PERICARDIAL HEART VALVE - MODEL DL
• Type of Device: TISSUE HEART VALVE
• Manufacturer (Section D): LIVANOVA CANADA CORP.; 5005 north fraser way; burnaby, bc
• Manufacturer (Section G): LIVANOVA CANADA CORP.; 5005 north fraser way; burnaby, bc
• Manufacturer Contact: francesca crovato ; 5005 north fraser way; burnaby, bc ; 4125650
• MDR Report Key: 6268751
• MDR Text Key: 65453059
• Report Number: 3004478276-2016-00191
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000160
• UDI-Public: (01)00896208000160(240)DLA21(17)170531
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2017
• Device Model Number: DLA
• Device Catalogue Number: DLA21
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/19/2012
• 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): Required Intervention
• Patient Age: 81 YR