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

Model Number PVS23

Device Problem Material Too Rigid or Stiff (1544)

Patient Problems Death (1802); Disseminated Intravascular Coagulation (DIC) (1813); Pneumonia (2011); Thrombosis (2100)

Event Date 04/17/2019

Event Type  Death  

Event Description

On (b)(6) 2019, a female patient received a perceval pvs23 in aortic position.At the end of the procedure, a mean gradient of 2mmhg was recorded.Several days later (exact date unknown), the patient became symptomatic; an echo was performed and a mean gradient of 70mmhg was registered.Two leaflets of the device (reportedly "at 6 o'clock and 10 o'clock") were relatively stuck to each other, and it appeared that there was fibrinous material on the leaflets.On (b)(6) 2019, the patient was brought to the operating room, she arrested and received cpr.The pvs23 remained well seated.The patient was consequently put on pump via the groin, the chest was opened, her heart was stopped and the perceval was explanted.A standard sutured valve was ultimately implanted.The patient was able to come off pump easily.Despite she was put on ecmo support, she passed away on the same day due to her major inflammatory response and disseminated intravascular coagulation (dic).Based on the surgeon's assessment, the patient may have developed thrombus on the valve as part of the dic related to her bad pneumonia (pneumonia was not present pre-operatively).It was a quite fulminant dic (intraoperative platelets count was 8, fibrinogen was 34, inr around 5).

Manufacturer Narrative

The manufacturing and material records for the perceval heart valve, model #icv1209, s/n # (b)(4), an its nitinol component, as they pertain to the reported event, were retrieved and reviewed by quality engineering.The results confirmed that this valve satisfied all material, visual, and performance standards required at the time of manufacture and release.Review of the steady flow test pictures demonstrate the acceptable opened and closed leaflet performance of the perceval pvs23 sn# (b)(4).No anomalies are observed during the open/close cycle.The valve, therefore, meets the acceptance criteria of the steady flow test inspection defined in 850-08ip203 rev v, the principal device function test at the time of release.

Manufacturer Narrative

Visual examination of the valve revealed a deformed valve due to large thrombus depositions on the both sides of the valve.X-ray inspection of the device showed no calcification.The histopathological analysis revealed presence of inflammatory cells spread inside the pericardium and inside the thrombus.There was no evidence of endocarditis in the returned valve.Based on the case history reported, the patient may have developed thrombus on the valve as part of the dic (disseminated intravascular coagulation) related to pneumonia.However, based on the limited information available and the returned condition of the device, it is not possible to draw a definitive conclusion about the relationship between the device and the reported event.

Manufacturer Narrative

The device was returned to the manufacturer and it was received on 28 may 2019.The returned package contained two jars.The first jar stored the complained valve, received with blood stains on the pericardium.Traces of pannus can be identified particularly on the inflow ring of the valve and on the stent.On the pericardium was oserved organic deposition whose nature will be determined in the next phases of investigation.Part of the tissue was excised from leaflet 1 and leaflet 2.The inflow side of the valve appeared slighlty deformed.The second jar contained the sternal plates and screws.Further investigation is ongoing.

• 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: 8606168
• MDR Text Key: 144920306
• Report Number: 3004478276-2019-00161
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000429
• UDI-Public: (01)00896208000429(240)ICV1209(17)211218
• Combination Product (y/n): N
• PMA/PMN Number: P150011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/18/2021
• Device Model Number: PVS23
• Device Catalogue Number: ICV1209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention