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

Model Number PVS23

Device Problems Perivalvular Leak (1457); Inadequacy of Device Shape and/or Size (1583); Device Dislodged or Dislocated (2923)

Patient Problem Aortic Regurgitation (1716)

Event Date 10/13/2017

Event Type  Injury  

Manufacturer Narrative

This event is being reported in a conservative manner, given that clinical assessment deemed the event to be procedure-related and not device-related.Device available but not yet received.

Event Description

A perceval pvs 23/m was implanted via mini-sternotomy in an obese female patient with difficult exposition.The pre-operative echo measurement of the annulus was 23.4 mm, and the stj was 22.5 mm.After normal decalcification, the surgeon was in doubt about whether to implant a perceval size large or medium, because the medium obturator passed through the annulus with force.The surgeon decided to implant the medium valve.After deploying the perceval and verifying the position, the surgeon ballooned for 30s at 4 atm, then checked the position again.The aorta was then closed, and the cross-clamp was removed.The echo on full bypass with the heart empty looked good.When lowering the ecc to 1 l/min, they saw a small paravalvular leakage which they didn't want to accept.Therefore, they converted to full sternotomy and went back on full bypass.During conversion the heart "blew up", with a high pressure in the left ventricle and low pressure in the aorta.Since the surgeon used a trans-annular vent, there was no left vent in place to empty the heart.Therefore the surgeon placed a left vent in the pulmonary vein, gently "lifting up" the heart.The left vent couldn't fully empty the heart, but when the surgeon clamped the aorta again the left vent was able to empty the heart.When the surgeon opened the aorta again while on full bypass, he identified the perceval upside down on the ventricular side of the aortic annulus.The perceval was removed and replaced with a perimount magna ease 21 mm.The patient didn¿t have any consequences and was released from the hospital within the usual timeframe.60 minute of cross-clamp time were added as a result of the event.Per clinical assessment, the build-up of pressure in the lv and subsequent displacement of the valve was procedure-related and not related to the valve.

Manufacturer Narrative

The device was received for analysis on (b)(6) 2017.The returned prosthesis was observed to be in generally good condition.Visual inspection was performed according to the procedure (b)(4) (revision at the time of manufacture and release).No anomalies or non-conformities were observed.

Manufacturer Narrative

Based on the investigations performed, the event cannot be described by any factor intrinsic to the involved device.According to the event details provided, the patient's annulus was measured to be 23.4 mm.According to the perceval ifu, the pvs23 is indicated for used in patient annulus diameters ranging from 21-23 mm.As such, the perceval valve was undersized, and the event can reasonably be attributed to this mis-sizing.This is consistent with the physician's report that the valve may have been undersized due to poor visibility.

Event Description

A perceval pvs 23/m was implanted via mini-sternotomy in an obese female patient with difficult exposition.The pre-operative echo measurement of the annulus was 23.4 mm, and the stj was 22.5mm.After normal decalcification, the surgeon was in doubt about whether to implant a perceval size large or medium, because the medium obturator passed through the annulus with force.The surgeon decided to implant the medium valve.After deploying the perceval and verifying the position, the surgeon ballooned for 30s at 4 atm, then checked the position again.The aorta was then closed, and the cross-clamp was removed.The echo on full bypass with the heart empty looked good.When lowering the ecc to 1l/min, they saw a small paravalvular leakage which they didn't want to accept.Therefore, they converted to full sternotomy and went back on full bypass.During conversion the heart "blew up", with a high pressure in the left ventricle and low pressure in the aorta.Since the surgeon used a trans-annular vent, there was no left vent in place to empty the heart.Therefore the surgeon placed a left vent in the pulmonary vein, gently "lifting up" the heart.The left vent couldn't fully empty the heart, but when the surgeon clamped the aorta again the left vent was able to empty the heart.When the surgeon opened the aorta again while on full bypass, he identified the perceval upside down on the ventricular side of the aortic annulus.The perceval was removed and replaced with a perimount magna ease 21mm.The patient didn¿t have any consequences and was released from the hospital within the usual timeframe.60 minute of cross-clamp time were added as a result of the event.It was reported that the event may have been attributable to mis-sizing, due to bad visibility through mini-sternotomy in an obese patient; however, the root cause of the event was ultimately unknown.It was also reported that the heart was not manipulated after implantation, and that the surgeon checked the positioning of the perceval after partial deployment of the valve.The build-up of pressure in the left ventricle was believed to be attributable to the displacement of the perceval into the outflow tract.

• 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 V5J5M 1; CA V5J5M1
• Manufacturer (Section G): LIVANOVA CANADA CORP.; 5005 north fraser way; burnaby, bc
• Manufacturer Contact: francesca crovato ; 5005 north fraser way; burnaby, bc
• MDR Report Key: 7010078
• MDR Text Key: 91361812
• Report Number: 3004478276-2017-00184
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000429
• UDI-Public: (01)00896208000429(240)ICV1209(17)210316
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: P150011
• 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: 01/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 03/16/2021
• Device Model Number: PVS23
• Device Catalogue Number: ICV1209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2017
• 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: 73 YR
• Patient Weight: 86