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

Model Number PVS21

Device Problem Insufficient Information (3190)

Patient Problems No Code Available (3191); Thrombocytopenia (4431)

Event Date 01/08/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).The manufacturer is following up to retrieve additional information on the patient's clinical history and device functionality to further evaluate the relationship between the reported event and the device.Device remains implanted.

Event Description

On (b)(6) 2021, a perceval valve pvs21 was implanted with a midline incision and the avr procedure was completed without any problems such as leaks after declamping.The cross clamp time for this procedure was 79 minutes.The preoperative platelet level was 217,000; immediately after surgery, the platelet count dropped at 76,000; blood transfusion of ffp was done only during surgery.The platelet level on the next day was 56,000; day 2 at 14,000; and day 3 at 11,000.Then, a blood transfusion of 20 units of platelets was needed.On (b)(6) 2021, the platelet level was 22000 and another transfusion of platelet was performed.On (b)(6) 2021, the platelet level was 57000, and the patient's appetite was declining.The pericardial fluid has accumulated so pericardial drainage may be required.The patient has no allergies and is not a dialysis patient.The valve remains implanted, but no further information on the device functionality was provided at this time.

Manufacturer Narrative

Per sales no further information is available.Surgeon has resigned from the site.The manufacturing and material records for the perceval heart valve, model #icv1208 , 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 #icv1208) perceval heart valve at the time of manufacture and release because the device remains implanted and no further information is available no additional investigations are possible at this time.The dhr review confirmed the device met all required standards at the time of manufacture and release.Based on the information the patient platelet count increased after transfusion but there was no indication if the issue was resolved.At this time there is no indication of valve malfunction or relationship to the event, thus the root cause of the reported event is cause not established.

• 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: 11290164
• MDR Text Key: 230730640
• Report Number: 3004478276-2021-00123
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000412
• UDI-Public: (01)00896208000412(240)ICV1208(17)230108
• 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
• Report Date: 04/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/08/2023
• Device Model Number: PVS21
• Device Catalogue Number: ICV1208
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 79 YR