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

Model Number PVF-M

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Insufficient Information (4580)

Event Date 05/04/2021

Event Type  Injury  

Manufacturer Narrative

The manufacturing and material records for the perceval plus heart valve, model #pvf-m, s/n # (b)(4), 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 #pvf-m) perceval plus heart valve at the time of manufacture and release.Since the device was not returned to the manufacturer at the time of the event, and no further information was received on its disposition, no further investigation is possible at this time.The manufacturer attempted to retrieve additional information on this event, and the device involved.However, no further information has been provided to date, despite the manufacturer's attempts.Based on the available information, it is not possible to establish a definitive root cause for the reported event.However, from the document review performed, no manufacturing deficiencies were identified.Given that the perceval plus valve pvf-m was replaced with a smaller perceval valve pvs21, the most probable root cause based on the available information can be traced to a device mis-sizing (use error).Should any further information be received in the future, the manufacturer will provide an update to this reporting activity.Unknown disposition.

Event Description

The manufacturer was informed on this event through the patient tracking database.Based on the information received from the patient implant form, a perceval plus valve model pvf-m was implanted and explanted on (b)(6) 2021.The valve was replaced with a perceval valve model pvs21.No further information is presently available.No allegation of a device malfunction nor of a serious injury for the patient was received from the hospital regarding this event.

• Brand Name: PERCEVAL PLUS SUTURELESS AORTIC HEART VALVE
• Type of Device: TISSUE HEART VALVE
• Manufacturer (Section D): CORCYM CANADA CORP.; 5005 north fraser way; burnaby, bc V5J 5 M1; CA V5J 5M1
• Manufacturer (Section G): CORCYM CANADA CORP.; 5005 north fraser way; burnaby, bc V5J 5 M1; CA V5J 5M1
• Manufacturer Contact: francesca crovato ; 5005 north fraser way; burnaby, bc V5J 5-M1 ; CA V5J 5M1
• MDR Report Key: 13690926
• MDR Text Key: 286857380
• Report Number: 3004478276-2022-00132
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000801
• UDI-Public: (01)00896208000801(240)PVF-M(17)220515
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P150011/S013
• 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
• Report Date: 03/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/15/2022
• Device Model Number: PVF-M
• Device Catalogue Number: PVF-M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/08/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/15/2020
• 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: 77 YR
• Patient Sex: Female