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

Model Number PVS27

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Information (3190)

Event Date 04/05/2018

Event Type  Injury  

Manufacturer Narrative

Device was discarded.

Event Description

An avr was performed concomitantly with a 2xcabg procedure.Sizing was reportedly done properly, and the patient was indicated for a perceval pvs27.When weaning from bypass, an intra aortic balloon pump (iabp) was implanted to assist the patient.When the iabp is turned on, the perceval migrated into the left ventricle.The surgeon reopened the aorta, redeployed the perceval valve, and closed the aorta.When the iabp was turned on again, the perceval valve again migrated into the lv.The perceval was taken out and a trifecta size 27 was implanted.The valve was subsequently discarded.The patient is outcome was good.

Manufacturer Narrative

The manufacturing and material records for the perceval heart valve, model #icv1211 , s/n # (b)(4), as they pertain to the reported event, were retrieved and reviewed by quality engineering at livanova canada corp.The results confirmed that this valve satisfied all material, visual, and performance standards required for a (model #icv1211) perceval heart valve at the time of manufacture and release.Based on the information received there is no clear indication of the root cause of the valve migration.Because the trifecta was a size 27, the same as the perceval valve, and was implanted supra-annularly mis-sizing is not an expected root cause.No deformation or kinking of the device was observed.In addition follow-up confirmed no difficulties with the holder and release of the valve were observed.Because the device is not available for further evaluation the root cause of the reported event cannot be determined at this time.If the manufacturer receives further information pertaining to the event the case will be re-opened for analysis.This mdr has been already submitted july 6, 2018 and resubmitted due to missing 3rd acknowledgment.

Event Description

On (b)(6) 2018 an avr was performed concomitantly with a 2xcabg procedure.Sizing was reportedly done properly, and the patient was indicated for a perceval pvs27.When weaning from bypass, an intra aortic balloon pump (iabp) was implanted to assist the patient.A pressure of 100 mmhg was used.When the iabp was turned on, the perceval migrated into the left ventricle.The surgeon reopened the aorta, redeployed the perceval valve, and closed the aorta.When the iabp was turned on again, the perceval valve again migrated into the lv.The perceval was taken out and a trifecta size 27 was implanted supra-annularly.The valve was subsequently discarded.The patient is outcome was good.

• 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: 7497020
• MDR Text Key: 107694456
• Report Number: 3004478276-2018-00185
• 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: 07/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 02/10/2021
• Device Model Number: PVS27
• Device Catalogue Number: ICV1211
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention