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

Model Number PVS23

Device Problem Malposition of Device (2616)

Patient Problem Ventricular Fibrillation (2130)

Event Date 05/23/2022

Event Type  Injury  

Event Description

On (b)(6) 2022, a perceval sutureless aortic heart valve pvs23 was implanted.After de-clamp, ventricular fibrillation occurred.There was no leakage.It was suspected that coronary obstruction occurred due to placement of the device at a position higher than normal.After cross clamp again, the device was explanted and another perceval pvs23 was implanted at the correct position.The surgery was completed without any problem.Patient's impact was that the surgery time was extended by 30 minutes.The patient remained stable throughout the delay in surgery.The patient has recovered.The patient is dialysis patient.As reported by the physician on the valve mispositioning, the sutures may have been pulled too hard during the implantation.

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 the manufacturer¿s quality engineering.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.The device is reportedly available for return.Thus, further investigation will be performed upon receipt.

Manufacturer Narrative

The device was returned to the manufacturer for investigation.The received valve has no pre-existing defects, and resulted within the specifications required at the time of manufacture and release.The height of each leaflet was checked and resulted in conformity.Based on the investigation performed, the reported event cannot be explained by any factor intrinsic to the returned prosthesis.No manufacturing deficiencies were identified during the document review performed, and the returned prosthesis resulted within the specifications.In agreement with the information reported from the physician, the root cause of the reported event can be traced to a use error (i.E.''sutures may have been pulled too hard during implantation'').

• 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: 14748740
• MDR Text Key: 295029468
• Report Number: 3004478276-2022-00158
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000429
• UDI-Public: (01)00896208000429(240)ICV1209(17)241215
• 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: 07/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PVS23
• Device Catalogue Number: ICV1209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2021
• 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: 85 YR
• Patient Sex: Female