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

Model Number PVS23

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem No Information (3190)

Event Date 11/24/2017

Event Type  Injury  

Manufacturer Narrative

The manufacturer is presently attempting to follow-up to determine more information regarding the details of this event.Once additional information has been received, appropriate investigative actions will be taken.The manufacturer has received notification that the device is available for return, however the device has not been received for analysis.Device not yet returned to manufacturer.

Event Description

The manufacturer was notified about an incident that while deploying a percival valve size medium, the valve did not deploy correctly and as a result was removed.A new percival valve was implanted.The valve deployed correctly and the operation finished.

Manufacturer Narrative

Updated fields: corrected hospital information.

Event Description

The manufacturer was notified about an incident that while deploying a perceval valve size medium, the valve did not deploy correctly (one of the leaflets reportedly looked folded) and as a result was removed.The nurse apparently had some difficulty collapsing the valve prior to implant.A new perceval valve of the same size was then implanted.The valve deployed correctly and the operation finished.The added cross-clamp time resulting from the event was 10-15 minutes.The patient remained stable throughout the delay in procedure, and recovered normally.

Manufacturer Narrative

The manufacturing and material records for the perceval heart valve, model #icv1209 , s/n # (b)(4), as they pertain to the reported event, were retrieved and reviewed by quality engineering at livanova (b)(4) 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.Visual inspection of the returned valve was performed in accordance with internal procedure (850-08ip200 - current revision at the time of manufacture and release).The inspection confirmed the absence of any elements of non-conformity.The geometry of the inflow ring was observed to be slightly deformed (not perfectly circular); however, this can reasonably be attributed to the explant procedure.A collapsing and deployment simulation was then performed with the returned device, using a demonstration accessory kit.No anomalies were encountered during the positioning, collapsing or deployment phases.In particular, no folding of the valve leaflets was observed.Based on the investigations performed, the reported issue cannot be explained by any factor intrinsic to the involved device.Given that a perceval valve of the same size was ultimately implanted, mis-sizing and patient anatomy can also be excluded as possible contributing causes of this event.By exclusion of other possible causes, the reported event can reasonably be attributed to malpositioning, and it is concluded that the operational context contributed to the event.

• Brand Name: PERCEVAL SUTURELESS AORTIC HEART VALVE
• Type of Device: TISSUE HEART VALVES
• Manufacturer (Section D): LIVANOVA CANADA CORP.; 5005 north fraser way; burnaby, bc V5J5M 1; CA V5J5M1
• MDR Report Key: 7329148
• MDR Text Key: 102070425
• Report Number: 3004478276-2018-00150
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000429
• UDI-Public: (01)00896208000429(240)ICV1209(17)210504
• 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: 06/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/04/2021
• Device Model Number: PVS23
• Device Catalogue Number: ICV1209
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention