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

Model Number PVS25

Device Problem Malposition of Device (2616)

Patient Problem Insufficient Information (4580)

Event Date 12/13/2021

Event Type  Injury  

Event Description

On (b)(6) 2021, a perceval valve pvs25 was attempted to be implanted.When the device was placed, the device was malpositioned.As such, the device was removed and another valve was implanted during the same day.Cross-clamp time was 47 minutes.

Manufacturer Narrative

The device was returned to the manufacturer for investigation.After decontamination, the valve was visually inspected and it was confirmed that the received valve has no pre-existing defects.The height of each package leaflet was checked and led to compliance.The valve appeared to meet the specifications for a pvs l/25.Furthermore, the manufacturing and material records for the perceval heart valve, model #icv1210, s/n # (b)(6), including the nitinol stent component, as they pertain to the reported event, were retrieved and reviewed by the manufacturer¿s quality engineering.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.Based on the investigation performed, the root cause of the reported event cannot be traced to the device, in agreement with the medical judgement received.The root cause of the reported event can be traced to an use error (device mispositioning).No product malfunctions occurred, as confirmed by the medical judgment received and by the investigations performed.Furthermore, the event did not result in serious injury for the patient, who remained stable during the procedure and had a good outcome after surgery.

Event Description

On (b)(6) 2021, a perceval valve pvs25 was attempted to be implanted.When the device was placed, the device was malpositioned.As such, the device was removed and another valve was implanted during the same day.Cross-clamp time was 47 minutes.Based on additional provided, there was a medical judgement from the surgeon that there was no relation between the device and event.No device malfunction was found.The surgeon noticed malpositioning before the de-clamp, but did not report cause of malpositioning.There was no significant delay added to the procedure as reported.The patient remained stable during the procedure and was discharged from the hospital without any problem.

• Brand Name: PERCEVAL SUTURELESS AORTIC HEART VALVE
• Type of Device: TISSUE HEART VALVE
• Manufacturer (Section D): CORCYM CANADA CORP.; 5005 north fraser way; burnaby, bc
• Manufacturer (Section G): CORCYM CANADA CORP.; 5005 north fraser way; burnaby, bc
• Manufacturer Contact: francesca crovato ; 5005 north fraser way; burnaby, bc
• MDR Report Key: 13201208
• MDR Text Key: 284978683
• Report Number: 3004478276-2022-00111
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000436
• UDI-Public: (01)00896208000436(240)ICV1210(17)231106
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/09/2022

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: 11/06/2023
• Device Model Number: PVS25
• Device Catalogue Number: ICV1210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/13/2021
• Initial Date FDA Received: 01/09/2022
• Supplement Dates Manufacturer Received: 01/12/2022
• Supplement Dates FDA Received: 02/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/06/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 56 KG