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

Model Number PVS23

Device Problems Collapse (1099); Malposition of Device (2616); Difficult to Open or Close (2921)

Patient Problems Aortic Insufficiency (1715); No Known Impact Or Consequence To Patient (2692)

Event Date 09/11/2019

Event Type  Injury  

Manufacturer Narrative

The device pvs 23 (sn (b)(4)) and the accessories dual collpaser s/m ((b)(4)) and dual holder (sn unknown) were returned to the manufacturer and were received on 01 oct 2019.The returned valve was received in generally good conditions, with the pericardium slightly darkened.The returned accessories were received deeply blood stained and the holder capote was damaged.

Event Description

On (b)(6) 2019, a male patient received a pvs23 in aortic position.During the same procedure, two other concomitant procedures were performed: a mitral valve repair ultimately converted to a mitral valve replacement and a tricuspid valve repair.Off cross-clamp and on echo it was noticed a severe central leak on the perceval valve.The aorta was then cross-clamped again and, after the aortotomy, it was noticed a papillary/chordal hindrance of perceval which was kinking the side of the perceval causing one of the leaflets to become immobile.The perceval was consequently explanted, the tissue causing the hinderance was excised and a new size m perceval was implanted.Once off cross-clamp, the valve looked good but a ventricular tear was noticed.The patient was put on bypass again to fix the tear.After that, the patient was weaned from bypass with good vitals and good valve functionality.

Manufacturer Narrative

The visual inspection performed on the returned prosthesis confirmed the absence of pre-existing defect.No anomalies were observed on the returned accessories.The dimensional verification confirmed that the returned pvs 23/m valve meets the specifications.Based on the performed analysis, the reported event cannot be explained by any factor intrinsic to the involved device.As reported in the case history, the malpositioning can be reasonably attributed to the user/procedure (i.E.Difficulties encountered with the guiding sutures).It should be noted that the perceval ifu indicates that an explanted perceval valve must not be re-implanted, because its integrity is no longer ensured.As such, both the re-implantion of the device and implanting the device without the use of the guiding sutures are off-label uses of the device.

Event Description

On (b)(6) 2019, a perceval pvs23 was intended to be used in an aortic valve replacement (avr) procedure.During the same surgery, two other concomitant procedures were performed: a mitral valve repair ultimately converted to a mitral valve replacement (performed with a competitor¿s valve, before the avr) and a tricuspid valve repair (using a competitor¿s ring, not confirmed if before or after the avr).After the deployment of the pvs23, malposition of the device was noticed, which was attributed to difficulties encountered with the guiding sutures.Therefore, the pvs23 was explanted and re-collapsed.The pvs23 was re-implanted without the use of the guiding sutures this time.Off cross-clamp and on echo it was noticed a severe central leak on this perceval valve.The aorta was cross-clamped again and, after artotomy, it was noticed a papillary/chordal hindrance of perceval which was kinking the side of the perceval causing one of the leaflets to become immobile.The impingement was noticed at the side of the leaflet, in correspondence of the inflow level of the valve; as reported, the hindrance was caused by the patient¿s anatomy and no issue with the device was detected.The pvs23 was consequently explanted, the tissue causing the hinderance was excised and a new size m perceval was implanted, without the use of guiding sutures.Once off cross-clamp, the valve looked good but a ventricular tear was noticed (reportedly not related to neither of the two perceval valves).The patient was put on bypass again to fix the tear.After that, the patient was weaned from bypass with good vitals and good valve functionality.

• 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: 9164338
• MDR Text Key: 161828690
• Report Number: 1718850-2019-01101
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000429
• UDI-Public: (01)00896208000429(240)ICV1209(17)220605
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 09/11/2019,11/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/05/2022
• Device Model Number: PVS23
• Device Catalogue Number: ICV1209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/11/2019
• Device Age: 3 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/11/2019
• Date Manufacturer Received: 09/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR