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

Model Number	PVS27
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturing and material records for the perceval heart valve, model #icv1211 , s/n # a96362, 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 or Problem 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
• Common Device Name: TISSUE HEART VALVE
• Manufacturer (Section D): LIVANOVA CANADA CORP.; 5005 north fraser way; vancouver, british columbia V5J5M 1; CA V5J5M1
• MDR Report Key: 11638188
• Report Number: 1718850-2021-01054
• Device Sequence Number: 11602159
• Product Code: LWR
• UDI-Device Identifier: 00896208000443
• UDI-Public: (01)00896208000443(240)ICV1211(17)230327
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/08/2021
• Report Date (Section F): 03/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/27/2023
• Device Model Number: PVS27
• Device Catalogue Number: ICV1211
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/09/2021
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/09/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR