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

Model Number PVS21

Device Problem Positioning Failure (1158)

Patient Problem Insufficient Information (4580)

Event Date 10/17/2022

Event Type  Injury  

Event Description

On (b)(6) 2022, a perceval sutureless aortic heart valve pvs21 was attempted to be implanted through mics procedure.Reportedly, stj was quite narrow, and the visual field was poor.Thus, the lcc part of the perceval implanted in slightly higher position.As such, the valve was explanted and another pvs21 was opened and implanted.No further information is available at this time.

Manufacturer Narrative

Was not returned by site.

Manufacturer Narrative

Updated fields: b4, g3, g6, h2, h6.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 the manufacturer¿s quality engineering.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.Based on the information available, stj was quite narrow, the visual field was poor and the lcc part of the perceval implanted in slightly higher position.Furthermore, from the document review performed, no manufacturing deficiencies were identified.As such, the cause of the reported malpositioning event was reasonably attributed to patient anatomy.Should further information be received in the future, a follow up report will be submitted.

Event Description

The manufacturer was informed that on 17 oct 2022, a perceval sutureless aortic heart valve pvs21 was attempted to be implanted through mics procedure.Reportedly, stj was quite narrow, and the visual field was poor.Thus, the lcc part of the perceval implanted in slightly higher position.As such, the valve was explanted and another pvs21 was opened and implanted.Based on the further information received, no malfunction with the device was noted and the device was not considered as a contributary factor to the event.Reportedly, only 15 minutes was added to the procedure as a result of the reported event.There was no impact on the patient and patient was stable through the delay in the procedure.

Manufacturer Narrative

Updated fields: b4, b5, g3, g6, h2.Based on the information available, stj was quite narrow, the visual field was poor and the lcc part of the perceval implanted in slightly higher position.Reportedly, no malfunction with the device was noted and the device was not considered as a contributary factor to the event.Furthermore, from the document review performed, no manufacturing deficiencies were identified.As such, the cause of the reported malpositioning event was reasonably attributed to patient anatomy.Should further information be received in the future, a follow up report will be provided.

• 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: roberta lamberti ; 5005 north fraser way; burnaby, bc
• MDR Report Key: 15794948
• MDR Text Key: 303630304
• Report Number: 3004478276-2022-00208
• Device Sequence Number: 1
• Product Code: LWR
• 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,Followup
• Report Date: 01/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PVS21
• Device Catalogue Number: ICV1208
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2021
• 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 Sex: Female