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

Model Number PVS23

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Cardiac Arrest (1762)

Event Date 06/05/2020

Event Type  Injury  

Event Description

On (b)(6) 2020 a patient received a perceval pvs23 sutureless aortic heart valve as part of an avr.Tto post operatively showed a good implant.During the icu period the patient had cardiac arrest.A resuscitation procedure was performed with thoracic massage.A coronarography was performed showing a massive leak.The valve had migrated.The patient was then re-operated, the valve explanted and replaced by a stented valve on (b)(6) 2020.

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 was notified that no further information regarding the event is available.Because the device was not available for return and no further information is available no further investigations can be performed.As no information is available the root cause of the reported cardiac arrest cannot be determined at this time.As indicated in the initial report the valve was dislodged after cpr was performed on the patient.The instructions for use (ifu) for a perceval s valve states; after perceval s implantation, manipulation of the heart and/or of the ascending aorta, if required, should be done gently; should an atrial retractor be placed, take care not to compress the ascending aorta.These maneuvers may lead to unknown effects on the implanted valve, including displacement and folding.Patients with implanted perceval s valve may experience valve deformation when emergency cardiovascular procedures, such as cardiopulmonary resuscitation (cpr), are administered post implant.In such cases, an echocardiographic exam post-procedure is recommended, in order to verify the preserved position and function of the valve.This indicates that it is clearly outlined in the ifu that a known inherent risk of cpr is displacement of the valve.Based on the above analysis, and supporting information from the instructions for use, the adverse event cannot be attributed to factors intrinsic to the device in question.The root cause of the dislodgement is a result of the cpr, which is identified as a known inherent risk of procedure in the ifu.

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.

• 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: 10248917
• MDR Text Key: 198327910
• Report Number: 1718850-2020-01104
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000429
• UDI-Public: (01)00896208000429(240)ICV1209(17)230414
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup,Followup
• Report Date: 06/09/2020,10/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2023
• Device Model Number: PVS23
• Device Catalogue Number: ICV1209
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/15/2020
• Device Age: 13 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/09/2020
• Date Manufacturer Received: 06/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention