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

Model Number PVS21

Device Problem Degraded (1153)

Patient Problem No Information (3190)

Event Date 06/15/2020

Event Type  Injury  

Event Description

The manufacturer was informed of an early degeneration of the perceval treated by valve in valve, with corvalve 23.No further information is presently available.

Manufacturer Narrative

Since the device was not explanted and the serial number is unknown, no device investigation is possible at this time.Based on the limited information available, it is not possible to draw a definitive conclusion on the reported event.It should be noted that structural valve deterioration is listed as a possible adverse event in the perceval ifu.The event is, therefore, a known inherent risk of the device.Should further information be provided, the manufacturer will provide an update to this reporting activity.

Event Description

The manufacturer was informed of an early degeneration of the perceval s valve treated by valve in valve, with corvalve 23.The perceval s was implanted in 2014 in mini sternotomy.No further information is presently available.

Event Description

On (b)(6) 2014, a perceval valve pvs21 was implanted in aortic position via mini-sternotomy.The valve degeneration was first observed in (b)(6) 2019.The patient was treated by valve-in-valve in (b)(6) 2020.The manufacturer received additional information from the site identifying the following information.After the initial implantation of the perceval in postoperative, good hemodynamic state, absence of bleeding by redons.Correct compresses count.Electro-entrained rhythm on the electrocardiogram.In 2020 the patient was rehospitalized in cardiology to discuss a valve-in-valve aortic valve replacement in a context of bioprosthesis degeneration.Degeneration of bioprosthesis confirmed via echo with an average gradient of 55 mmhg across the aortic valve, paroxysmal anticoagulated af.Patient has a history of a kidney transplant in 2010 with dialysis since (b)(6) 2014 following graft dysfunction.In 2019 a assessment confirmed prosthesis degradation.There is a definite indication for hip prosthesis in the context of osteoarthritis.The patient requirement is high due to limited physical activity due to hip pain.Preoperative workup with coronary artery control found an atheromatous coronary network without significant lesion.Dampened flow and systolic ascension time increases on all asds in relation to aortic valve shrinkage.Dialysis fistula presence.Tavi procedure with a evolut pro 23mm valve was performed in (b)(6) of 2020.Review on (b)(6) 2020 confirmed good positioning of the evolut valve.Since the device was not explanted and the serial number is unknown, no device investigation is possible at this time.Structural valve deterioration is identified as a major cause of failure of bioprosthetic heart valves.It is possible that the patient¿s clinical history and risk factors (severe hypertension, ischemic heart disease) may have contributed to the structural valve deterioration observed in this perceval s valve.However a definitive root cause cannot be stated at this time.It should be noted that structural valve deterioration is listed as a possible adverse event in the perceval ifu as a known inherent risk of the device.

Manufacturer Narrative

Since the device was not explanted and the serial number is unknown, no device investigation is possible at this time.Based on the information available, it is not possible to draw a definitive conclusion on the reported event.It is possible that the patient¿s clinical history and risk factors may have contributed to the structural valve deterioration observed in this perceval s valve.It should be noted that structural valve deterioration is listed as a possible adverse event in the perceval ifu.The event is, therefore, a known inherent risk of the device.The manufacturer is submitting this as a late report.Due to an internal error the manufacturers sales team received the operational report but the operational report was not received by the customer quality team within the required timeline.Updated sections: b4, b5, d4, d6a, f6, f7.

• 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: 10673837
• MDR Text Key: 211448307
• Report Number: 1718850-2020-01170
• Device Sequence Number: 1
• Product Code: LWR
• 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: 09/16/2020,03/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PVS21
• Device Catalogue Number: ICV1208
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/28/2020
• Event Location: Hospital
• Date Report to Manufacturer: 09/16/2020
• Date Manufacturer Received: 02/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention