MAUDE Adverse Event Report: LIVANOVA CANADA CORP. PERCEVAL SUTURELESS AORTIC HEART VALVE; TISSUE HEART VALVE

Model Number PVS21

Device Problems Positioning Problem (3009); Insufficient Information (3190)

Patient Problem Mitral Regurgitation (1964)

Event Type  Injury  

Manufacturer Narrative

Device disposition presently unknown.

Event Description

The manufacturer received a notification of a device related adverse event recorded in a scientific paper.Ann thorac surg.2018 mar;105(3):e103-e105.Doi: 10.1016/j.Athoracsur.2017.10.001.Mitral regurgitation exacerbation due to sutureless aortic valve replacement.Lee t1, mittnacht ajc2, itagaki s3, stewart a3.(b)(6) event summary: a patient with aortic stenosis was to receive an avr using a perceval pvs21 aortic heart valve.In the abstract it states, ¿however, this implantation resulted in the exacerbation of mitral regurgitation.The sutureless valve required explantation, and a traditional sutured valve was subsequently implanted, which returned the mitral regurgitation to baseline.¿ the perceval valve was explanted and replaced with a magna ease (edwards lifesciences, (b)(4)) aortic valve.

Manufacturer Narrative

The manufacturer received further information on may 29, 2018.The operating physician informed the manufacturer that the valve was positioned too low.His assistant didn¿t have proper tension on the guiding sutures.The manufacturer will not be investigating the case any further.No device malfunction was identified and the root cause can be attributed to operational context.Changed fields: date of report, pma/510k and follow-up, what type.

• Brand Name: PERCEVAL SUTURELESS AORTIC HEART VALVE
• Type of Device: TISSUE HEART VALVE
• Manufacturer (Section D): LIVANOVA CANADA CORP.; 5005 north fraser way; burnaby, bc V5J 5 M1; CA V5J 5M1
• MDR Report Key: 7397653
• MDR Text Key: 104407766
• Report Number: 3004478276-2018-00163
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• PMA/PMN Number: P150011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: PVS21
• Device Catalogue Number: ICV1208
• Date Manufacturer Received: 05/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR