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 Hemorrhage/Bleeding (1888)

Event Date 06/26/2020

Event Type  Injury  

Event Description

On (b)(6) 2020 a patient received a perceval pvs23 as part of an avr.The manufacturer was notified that during the procedure the valve was placed and no leaks or backflow were detected via echo.The patient was de-clamped and weaned.However, the blood pressure decreased to vf after administration of protamine.Pcps was set in a hurry and the physician performed cpr during that time.Svg was collected, ao-rca bypass was performed, and then, once stable, but additional ao-lad was performed due to deterioration of the condition again.At this time, the heart was slightly turned upside down for placement of gauze under the heart.Since the condition was not stable even after two bypasses were performed, a guide wire was raised to the ascending aorta to place the iabp, but at the same time perceval was found in the descending aorta.Since it could not be taken out, a heart-lung machine was newly set and avr was performed with inspiris.Although it was declamped, blood flow to the lower limbs could not be confirmed, so it was determined that perceval rotated in the blood vessel.After the right coronary artery graft was performed a hemorrhage from the right ventricle occurred.The operator grabbed the heart and speculated the device may have dislodged at this time.The extended time of surgery due to this event is 360 minutes.The patient is stable now with a new bioprosthesis.Further information identified no clear device malfunctions occurred.The migrated valve was located at descending aorta so could not be removed without opening the artery.The valve was fixed by a stent graft to keep the up-side-down leaflets fully opened.The manufacturer confirmed the device was not explanted and that the edwards valve was implanted at the aorta with the perceval fixed in the descending aorta.No valve in valve was performed.Further information received identified the patient had a cerebral infarction post operatively, and the patient had been treated in the icu but died of dyspnea due to pneumonia on (b)(6) 2020.Heart failure had improved at the time of death.

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.Based on the information provided in the initial submission and the review of the device history records no device deficiencies were detected during manufacturing and release or during the adverse event.The manufacturer reported this event in a conservative manner due to the migrated perceval valve being left in the patient potentially increasing risk.However, based on the information from the event several procedural factors lead to the bleeding and manipulation of the heart which consequently resulted in the dislodgement of the perceval device.Administration of cpr leading to device migration is identified as a known inherent risk in the perceval instructions for use.The root cause of the event is therefore deemed to be cause cannot be traced to device : adverse event related to procedure.No further investigations will be performed.

• 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: 10544846
• MDR Text Key: 207302826
• Report Number: 1718850-2020-01142
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000429
• UDI-Public: (01)00896208000429(240)ICV1209(17)230228
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 08/18/2020,10/08/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: PVS23
• Device Catalogue Number: ICV1209
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/09/2020
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/18/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/17/2020
• Supplement Dates Manufacturer Received: 06/29/2020
• Supplement Dates FDA Received: 10/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Weight: 55