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

Model Number PVS27

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Complete Heart Block (2627)

Event Type  Injury  

Manufacturer Narrative

Since the device remains implanted and the serial number is unknown, no investigation is possible at this time.As such, based on the available information, it is not possible to define the root cause of the reported event.Conduction disorders are common in patients with aortic valve diseases.As a result, it is common for patients to receive permanent pacemaker implantation after aortic valve replacement.Risk factors include preexisting conducting disease and preoperative aortic regurgitation.This event is, therefore, a known, inherent risk of the procedure, and it is listed among the potential adverse events in the perceval ifu.The manufacturer has followed up with the paper¿s author to retrieve additional information on this event.If further information will be received, a follow up report will be submitted.Device not explanted.

Event Description

The manufacturer was informed on this event through the publication 'sutureless valve replacement through a right anterior mini-thoracotomy in elderly patients with stenotic bicuspid aortic valve' by durdu et al.This paper reports a single-center experience with the perceval s valve and retrospectively analyses data for 13 patients with a stenotic bicuspid aortic valve (bav).From january 2013 through march 2018, 13 patients with severe aortic stenosis involving bav underwent sutureless aortic valve replacement (su-avr) with the perceval-s.The central message of this paper is that su-avr is a technically feasible and safe procedure in as patients involving bav anatomy with acceptable good surgical outcomes.Among the results presented, it is mentioned that one patient (7.6%) required permanent pacemaker implantation due to a third-degree atrioventricular block.

Manufacturer Narrative

Based on the additional information reported from the field, the event was reportedly attributed to the excessive decalcification performed.There was no allegation of a device malfunction that could have caused or contributed to the reported event.As such the code provided in section h6 has been updated.

Event Description

The manufacturer was informed on this event through the publication 'sutureless valve replacement through a right anterior mini-thoracotomy in elderly patients with stenotic bicuspid aortic valve' by durdu et al.This paper reports a single-center experience with the perceval s valve and retrospectively analyses data for 13 patients with a stenotic bicuspid aortic valve (bav).From january 2013 through march 2018, 13 patients with severe aortic stenosis involving bav underwent sutureless aortic valve replacement (su-avr) with the perceval-s.The central message of this paper is that su-avr is a technically feasible and safe procedure in as patients involving bav anatomy with acceptable good surgical outcomes.Among the results presented, it is mentioned that one patient (7.6%) required permanent pacemaker implantation due to a third-degree atrioventricular block.Per additional information received, pre-operatively the patient was in sinus rhythm and very symptomatic (nhya class iv) due to highly stenotic type 0 bicuspid aortic valve.The native valve was excised and complete decalcification was performed.The perceval pvs27 was safely implanted.On postoperative day 9, the patient experienced a third-degree av block and a permanent pacemaker was implanted.In the follow-up, the patient is reportedly still very well with a dramatic improvement of the cardiac functions, despite the pace rhythm.Based on the assessment received from the field, the main reason for the pacemaker implant was attributed to the need to perform a complete decalcification of the severe stenotic bicuspid aortic valve.

• Brand Name: PERCEVAL SUTURELESS AORTIC HEART VALVE
• Type of Device: TISSUE HEART VALVES
• Manufacturer (Section D): LIVANOVA CANADA CORP; 5005 north fraser way; burnaby, british columbia
• MDR Report Key: 9448677
• MDR Text Key: 170325351
• Report Number: 3004478276-2019-00330
• 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: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 01/15/2020

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: Health Professional
• Device Model Number: PVS27
• Device Catalogue Number: ICV1211
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/12/2019
• Initial Date FDA Received: 12/10/2019
• Supplement Dates Manufacturer Received: 12/19/2019
• Supplement Dates FDA Received: 01/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR