MAUDE Adverse Event Report: CORCYM CANADA CORP (ALSO TRADING AS LIVANOVA CANADA CORP) PERCEVAL SUTURELESS AORTIC HEART VALVE; TISSUE HEART VALVE

Model Number PVS21

Device Problem Insufficient Information (3190)

Patient Problem Thrombocytopenia (4431)

Event Date 11/05/2020

Event Type  Injury  

Event Description

On (b)(6) 2020, the perceval was indwelled with a midline incision in combination with cabg.Preoperative platelets were 191,000.On the 3rd day after the operation, before discharge, it became 14,000 and 20 units of platelets were transfused.After that, it rose to 94,000, but fell again until the 9th day to 33,000.After that, it gradually increased, reaching 70,000 on the 21st day and 73,000 on the 31st day.The manufacturer was informed that the patient had rich bypass (collateral circulation).Since the chest was opened with avr, a cabg was also performed.However, the graft did not provide blood flow and was occluded.The graft occlusion was not associated with the thrombocytopenia based on the information reported.There was no ischemia even if the graft was occluded.The total cross-clamp time was of 92 minutes.

Manufacturer Narrative

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.

Event Description

See intiial report.

Manufacturer Narrative

Because the device remains implanted no additional investigations are possible at this time.The manufacturer attempted to retrieve additional information but none was provided to date.Based on the information available, it is not possible to draw a definitive root cause for the reported event.However, per the document review performed, no manufacturing deficiencies were identified with the perceval valve involved in the event.Thrombocytopenia (tcp) in cardiac surgery is a very well-known phenomenon.The etiology is multi-factorial due to multiple factors including hemodilution, blood loss with volume repletion with platelet-poor fluids, platelet activation, consumption and destruction due to contact with foreign surfaces.Tcp following aortic valve replacement (avr) is also a common phenomenon.Patient factors and prolonged extracorporeal circulation all being recognized predictors of tcp following cardiac surgery.Should further information be received in the future, the manufacturer will update this reporting activity as required.

• Brand Name: PERCEVAL SUTURELESS AORTIC HEART VALVE
• Type of Device: TISSUE HEART VALVE
• Manufacturer (Section D): CORCYM CANADA CORP (ALSO TRADING AS LIVANOVA CANADA CORP); 5005 north fraser way; burnaby V5J 5 M1; CA V5J 5M1
• MDR Report Key: 11389378
• MDR Text Key: 243405788
• Report Number: 1718850-2021-01024
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000412
• UDI-Public: (01)00896208000412(240)ICV1208(17)230123
• 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: 07/28/2021,08/27/2021

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: 01/23/2020
• 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: 07/28/2021
• Device Age: 9 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/28/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/26/2021
• Supplement Dates Manufacturer Received: 03/29/2021; 08/27/2021
• Supplement Dates FDA Received: 04/01/2021; 08/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 79 YR
• Patient Weight: 49