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

Model Number PVS23

Device Problems Material Invagination (1336); Insufficient Information (3190); Activation Failure (3270)

Patient Problem Aortic Valve Stenosis (1717)

Event Date 12/12/2018

Event Type  Injury  

Manufacturer Narrative

Device disposition not presently known.

Event Description

A perceval pvs23 was implanted on (b)(6) 2018.On (b)(6) 2018, the valve was reportedly explanted due to stenosis of the device.No other information was provided.

Event Description

A perceval pvs23 was implanted on (b)(6) 2018.On (b)(6) 2018, the valve was reportedly explanted due to stenosis of the device.It was reported that the valve was deformed and an attempt was made to balloon-dilate the device on december 20, 2018; however, the valve did not regain its original shape.A thoracotomy was therefore performed to remove the device and a medtronic biological valve was implanted.The re-operation went well and the patient returned to the ward, although post-operative electrocardiogram revealed third degree av block and a permanent pacemaker was implanted on (b)(6) 2018.

Manufacturer Narrative

The manufacturing and material records for the perceval heart valve, model #icv1209 , s/n # (b)(6), 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 #icv1209) perceval heart valve at the time of manufacture and release.The manufacturer has followed up for the return of the device; however, the device has not been received to date.As such, the device cannot be investigated and the root cause of the event cannot be established.Based on the document review performed, no manufacturing deficiencies were identified.If the device is received in the future, appropriate investigative action will be taken.

Manufacturer Narrative

The manufacturer was informed that the event date was updated.The remainder of the information previously submitted remains unchanged.

• 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
• MDR Report Key: 8257839
• MDR Text Key: 133387595
• Report Number: 3004478276-2019-00115
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000429
• UDI-Public: (01)00896208000429(240)ICV1209(17)191017
• 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,Followup
• Report Date: 08/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/17/2019
• Device Model Number: PVS23
• Device Catalogue Number: ICV1209
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention