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

Model Number PVS23

Device Problems Collapse (1099); Perivalvular Leak (1457); Inadequacy of Device Shape and/or Size (1583); Insufficient Information (3190)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 12/02/2019

Event Type  Injury  

Manufacturer Narrative

Device location not presently known.

Event Description

On (b)(6) 2019, a patient received a perceval pvs23 in aortic position.The device was explanted intraoperatively and replaced with a magna ease size 21.No other information on the reason for the explant is presently available.

Event Description

On (b)(6) 2019, a patient received a perceval pvs23 in aortic position.The device was explanted intraoperatively and replaced with a magna ease size 21.Per additional information received, the perceval valve was initially oversized.When weaning from bypass, a perivalvular leak was noted and a stent folding was identified.The surgeon explanted the device and decided to continue the procedure with a sewed valve.No perceived issue with the explanted pvs23 was reported.A good outcome for the patient is reported, who was discharged home and doing well.

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.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.Since the device was discarded, no further investigation is possible at this time.Based on the available information, the root cause of the reported event can be reasonably traced to an initial oversizing of the perceval valve as also confirmed from the information reported from the field, which is in line with livanova clinical experience.Should additional information be provided on this event, a follow-up report will be submitted.

• 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: 9528761
• MDR Text Key: 177995136
• Report Number: 3004478276-2019-00344
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000429
• UDI-Public: (01)00896208000429(240)ICV1209(17)201018
• 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: 01/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/18/2020
• Device Model Number: PVS23
• Device Catalogue Number: ICV1209
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention