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

Model Number PVS23

Device Problems Gradient Increase (1270); Perivalvular Leak (1457); Improper or Incorrect Procedure or Method (2017)

Patient Problems Aortic Regurgitation (1716); Death (1802)

Event Date 04/26/2017

Event Type  Injury  

Manufacturer Narrative

Due to limited information received to date the manufacturer is reporting in a conservative manner.Patient death occurred post operative after explant of pvs 23m.Not yet returned to manufacturer.

Event Description

On (b)(6) 2017 pvs 23m was implanted.Intra-operative echo displayed paravalvular leak on the non cusp and leaflet fluttering on the right cusp leaflet, with a mean gradient of 40mmhg.The patient was put back on crossclamp and the aortotomy re-opened.The physician's initial inspection showed a good position of the valve.Cold slush applied to root and valve removed using shodded hemostats and z maneuver.The annulus was inspected for further calcium, and a small chunk of calcium was removed in one area.The physician resized for the same size valve and then noted ridge of calcium in root and elected to implant an edwards 21 magna.The manufacturer has been notified that patient death occurred post operative.

Manufacturer Narrative

Updated information for follow up 1: date of patient death.Additional x clamp and cpb time.

Event Description

An additional 85 minutes of cpb time and 35 minutes x-clamp was added to the procedure due to the event.

Manufacturer Narrative

A review of the steady flow test prior to release for the perceval sutureless aortic heart valve model (b)(4) was performed.The review confirmed the absence of any coaptation anomalies, and the valve met all acceptance criteria of the steady flow test inspection, the principal device functionality test, at the time of release.

Manufacturer Narrative

Confirmation was received that the device is not available for analysis.As such, no device investigation can be performed and the root cause of this event cannot be determined.Based on the steady flow test review performed previously, no evidence of device deficiency was identified.Furthermore, according to the event narrative provided, a "chunk" of residual calcium was identified following explant of the perceval valve, and subsequently removed.Ultimately, an edwards valve was implanted because a ridge of calcium was still present in the annulus.According to the perceval ifu "eccentric/bulky protruding intraluminal calcifications must be removed" prior to implant of the perceval valve.It is therefore possible that this event arose from inadequate decalcification of the annulus and failure to follow the instructions in the ifu.Device not available for return.

• Brand Name: PERCEVAL SUTURLESS AORTIC HEART VALVE
• Type of Device: TISSUE HEART VALVES
• Manufacturer (Section D): LIVANOVA CANADA CORP; 5005 north fraser way; burnaby, bc
• 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: 6595431
• MDR Text Key: 76091367
• Report Number: 3004478276-2017-00097
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000429
• UDI-Public: (01)00896208000429(240)ICV1209(17)190602
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P15001
• 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,Followup
• Report Date: 01/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 06/02/2019
• Device Model Number: PVS23
• Device Catalogue Number: ICV1209
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention