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

Model Number PVS27

Device Problem Unintended Movement (3026)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/16/2020

Event Type  Injury  

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.Since the device disposition after the procedure is reportedly unknown and, ultimately, was not returned to the manufacturer, no further device investigation is possible at this time.Based on the information available, it is not possible to establish a definitive root cause for the reported event.Considering the information reported identifying no device malfunctions but "device rocking" identified at the tee post-implant, possible factors that may have contributed to the event include a device undersizing, device malpositioning or patient's related factors (i.E.Bulky calcium) which prevented a proper anchoring of the valve at the annulus level.Ultimately, since no details on the procedure was provided and no further investigation on the device was possible, the root cause remains unknown at this time.

Event Description

The manufacturer received information on this event through the patient tracking department.Based on the information reported in the patient registration form, on (b)(6) 2020, a patient was intended to receive a perceval pvsxl in aortic position.The device was reportedly explanted intraoperatively.Additional information received from the hospital confirmed that the valve was explanted due to valve rocking on post-implant tee.The perceval xl valve was replaced by a 27 mm st.Jude trifecta tissue valve.No device malfunctions were identified, and the patient had an excellent outcome after the procedure.The device disposition after the explant is unknown.During the same procedure, the following concomitant procedures were performed: bi-atrial cox-4 maze, and laa clip.The patient underwent aortic valve replacement due to severe aortic stenosis.

• Brand Name: PERCEVAL SUTURELESS AORTIC HEART VALVE
• Type of Device: TISSUE HEART VALVE
• Manufacturer (Section D): LIVANOVA CANADA CORP.; 5005 north fraser way; burnaby, british columbia V5J5M 1; CA V5J5M1
• Manufacturer (Section G): LIVANOVA CANADA CORP; 5005 north fraser way; burnaby, bc V5J 5 M1; CA V5J 5M1
• Manufacturer Contact: francesca crovato ; 5005 north fraser way; burnaby, bc V5J 5-M1 ; CA V5J 5M1
• MDR Report Key: 11638167
• MDR Text Key: 247255857
• Report Number: 3004478276-2021-00142
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000443
• UDI-Public: (01)00896208000443(240)ICV1211(17)230327
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/27/2023
• Device Model Number: PVS27
• Device Catalogue Number: ICV1211
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR