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

Model Number DLA

Device Problems Gradient Increase (1270); Material Too Rigid or Stiff (1544); Incomplete Coaptation (2507); Material Deformation (2976)

Patient Problems Aortic Insufficiency (1715); Aortic Valve Stenosis (1717)

Event Date 11/15/2016

Event Type  Injury  

Event Description

The manufacturer was notified on (b)(6) 2016 about the explant of mitroflow valve (dla), size 21 implanted in (b)(6) 2013 due to prosthetic degeneration.The echocardiographic monitoring of follow-up showed no problems until 2015.In (b)(6) 2016, evidence of moderate stenosis with gradient max 45 mmhg.After a few months re-appearance of symptoms for which echocardiographic control showed increase of peak gradient of 75 mmhg and mean gradient of 50 mmhg.Tte showed trans-prosthetic mean gradient of 38 mmhg and peak gradient of 60mmhg with valve cusps thickened.Without mitral insufficiency.Pap 30 mmhg.Good fiunzione vs.Ivs.Patient's medications: cardioaspirin.Bisoprolol 3.75.Amlodipine.Lasix cp 1 + 1 \ / 2 cp.Zyloric 150.Insulin humalog 6 + 6 + 6 u.Lantus 11 u.Cardiac risk factors: cardiovascular risk factors: family history of cvd.Smoke, mild hypercholesterolemia, hypertension, nid diabetes until the intervention and id from 2013.Past history: cholecystectomy.Saphenous varicose dx.Hyperuricemia.Low back pain.Anemia with positive sof, with gastro and colonoscopy in 2013 (erosive gastritis).(b)(6).

Manufacturer Narrative

Conclusion: this mitroflow valve was explanted after 3 years and 9 months due to reported structural valve deterioration.Leaflets calcification, detected with visual, x-ray and histological analyses, caused stiffening and led to progressive 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 conditions and risk factors (hypertension , aortic valve stenosis , diabetes and hypercholesterolemia) may have contributed to the structural valve deterioration observed in this mitroflow valve.

• 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 north fraser way; burnaby,
• Manufacturer Contact: francesca crovato ; 5005 north fraser way; burnaby, bc ; 4125696
• MDR Report Key: 6181979
• MDR Text Key: 62610972
• Report Number: 3004478276-2016-00162
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000160
• UDI-Public: (01)00896208000160(240)DLA21(17)170831
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P060038/S017
• 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
• Report Date: 05/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 08/31/2017
• Device Model Number: DLA
• Device Catalogue Number: DLA21
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/05/2012
• 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: 75 YR
• Patient Weight: 88