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

Model Number PVS25

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Heart Failure (2206)

Event Date 10/31/2018

Event Type  Injury  

Manufacturer Narrative

Device not explanted.

Event Description

The manufacturer was informed about this event through the (b)(6) study registry.On (b)(6) 2018, a (b)(6) years old female patient received a perceval pvs25 to replace the native aortic valve.It is reported that the patient suffered from a heart failure postoperatively due to the device migration.A new surgery was necessary to treat the patient.The device was explanted and re-implanted in the patient.The patient's symptoms disappeared after the device was properly positioned.At discharge from the hospital ((b)(6) 2018), the echo showed that the device was correctly positioned, with traces of aortic regurgitation and a mean gradient of 9mmhg.It is reported that the prolonged hospitalization was mainly due to the patient's request for more follow up and observation and that it was not caused by the adverse event occurred.Finally, it should be noted that this procedure was part of the first clinical trial in (b)(6) for the perceval s valve and that it was the second implant procedure that the surgeon performed.

Manufacturer Narrative

The manufacturing and material records for the perceval heart valve, model #icv1210 , 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 #icv1210) perceval heart valve at the time of manufacture and release.As the device remains implanted in the patient, no further investigation can be performed at this time.Based on the information received from the hospital, the valve appeared to be mispositioned after the implant.It is possible that the initial malpositioning of the perceval valve may have lead to valve migration.

Event Description

The manufacturer was informed about this event through the perfect study registry.On 31 oct 2018, a 73 years old female patient received a perceval pvs25 to replace the native aortic valve.No concomitant procedures were performed.It is reported that the decalcification was performed to make the annulus as much regular as possible.Postoperatively, the patient suffered from heart failure due to device migration.The migration is believed to be attributed to an initial malpositioning of the device.A new surgery was necessary to treat the patient and it was performed on the same day.The device was explanted and re-implanted in the patient.The patient's symptom disappeared after the device was properly positioned.At discharge from the hospital (b)(6) 2018, the echo showed that the device was correctly positioned, with traces of aortic regurgitation and a mean gradient of 9mmhg.It is reported that the prolonged hospitalization was mainly due to the patient's request for more follow up and observation and that it was not caused by the adverse event occurred.It should be noted that this procedure was part of the first clinical trial in china for the perceval s valve and that it was the second implant procedure that the surgeon performed.Additional information received on (b)(6) 2019 confirmed that migration was attributed to the procedure and not to the device.

• Brand Name: PERCEVAL SUTURELESS AORTIC VALVE
• Type of Device: TISSUE HEART VALVES
• Manufacturer (Section D): LIVANOVA CANDA CORP; 5005 north fraser way; burnaby, british columbia
• MDR Report Key: 8287640
• MDR Text Key: 134629374
• Report Number: 3004478276-2019-00117
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000436
• UDI-Public: (01)00896208000436(240)ICV1210(17)191011
• Combination Product (y/n): N
• PMA/PMN Number: P150011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup
• Report Date: 02/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/11/2019
• Device Model Number: PVS25
• Device Catalogue Number: ICV1210
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR