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

Model Number 12A

Device Problems Gradient Increase (1270); Material Too Rigid or Stiff (1544); Incomplete Coaptation (2507)

Patient Problems Aortic Valve Stenosis (1717); Calcium Deposits/Calcification (1758)

Event Date 02/09/2017

Event Type  Injury  

Event Description

It was reported that the patient had a re-operation for valve replacement due to leaflet immobility.After 2 years of implantation, on echocardiography, incomplete leaflet closing was confirmed for the patient¿s implanted mitroflow aortic valve size 19.Severe calcification was observed on the non-coronary cusp and right coronary cusp.A new valve, magna ease size 19 was implanted and re-operation was complete without problems.There was no dialysis history on this patient.There were no other factors considered that could possibly promote calcification, including medications.The patient¿s mean pressure gradient post-initial implant was 13.6 mmhg.In (b)(6) 2016 the mean gradient was 47.3 mmhg and by (b)(6) 2017 was at 58 mmhg.The patient's device was returned for analysis.

Manufacturer Narrative

The complete manufacturing and material records for the mitroflow bioprosthetic pericardial heart valve, model 12a19-, s/n (b)(4), were pulled and reviewed by quality control at livanova (b)(4).The results confirmed that this valve satisfied all material, visual, and performance standards required for a (model 12) mitroflow aortic pericardial heart valve at the time of manufacture and release.This mitroflow valve was explanted after 2 years and 2 months due to a reported prosthetic calcifications.Leaflet calcification, detected with visual, x-ray and histological analyses, caused stiffening and led to progressive valve stenosis.Pannus tissue overgrowth also contributed to stenosis.There was no evidence of endocarditis in the returned valve.Function test video was reviewed to qualitatively evaluate each valve in 4 phases: closed, opening, open and closing.Each function test video consists of approximately 5 open/close cycles.Criteria that were evaluated during the review are listed in the table below.Video was viewed at real time and frame by frame.All valves performed as expected and met all function test quality control criteria that can be observed during video playback.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.

• Brand Name: MITROFLOW AORTIC PERICARDIAL HEART VALVE
• 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 fraser north way; burnaby, bc
• Manufacturer Contact: francesca crovato ; 5005 fraser north way; burnaby, bc
• MDR Report Key: 6396746
• MDR Text Key: 69644805
• Report Number: 3004478276-2017-00018
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/18/2017

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: 05/30/2019
• Device Model Number: 12A
• Device Catalogue Number: 12A19
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/09/2017
• Initial Date FDA Received: 03/10/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2014
• 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: 67 YR
• Patient Weight: 44