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

Model Number PVF-XL

Device Problems Difficult to Fold, Unfold or Collapse (1254); Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 08/18/2021

Event Type  Injury  

Manufacturer Narrative

The manufacturing and material records for the perceval plus heart valve, model #pvf-xl , 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-xl) perceval plus heart valve at the time of manufacture and release.Since the device was not returned to the manufacturer at the time of explant, no further investigation is possible at this time.Based on the available information, it is not possible to draw a definitive conclusion to the reported event.However, from the documents review performed, no manufacturing deficiencies were identified.The manufacturer has requested additional information regarding this event, but none has been received to date.Should any further information be received in the future, a follow up report will be provided.Unknown device disposition.

Event Description

The manufacturer was informed of the event through the patient tracking department.Based on the information reported in the patient implant form, a perceval plus valve pvf-xl was implanted and explanted on the same day on (b)(6) 2021.Another perceval plus valve pvf-xl was finally implanted.No allegation of a device malfunction or patient serious injury was received from the site regarding this event.

Manufacturer Narrative

A complete manufacturing and material records review for the nitinol stent component has been performed.Since the device was not returned to the manufacturer, no further investigation is possible at this time.Based on the available information, and given that no inspection on the actual product involved was possible, the root for the reported event of collapsing difficulties cannot be established at this time.However, from the document review performed, no manufacturing deficiencies were identified.Ultimately, since the event added only 10min delay to the procedure, there is no evidence of a serious injury for the patient as a result of the reported event.Should further information related to the case be received in the future, a follow up report will be submitted as applicable.

Event Description

The manufacturer was informed of the event through the patient tracking department.Based on the information reported in the patient implant form, a perceval plus valve pvf-xl was implanted and explanted on the same day on (b)(6) 2021.Another perceval plus valve pvf-xl was finally implanted.No allegation of a device malfunction or patient serious injury was received from the site regarding this event.Per additional information received from the physician, it was clarified that the first valve did not collapse properly.As such, a new disposable kit and valve were used.This added approximately 10 min to the total procedure.The second perceval was collapsed/deployed successfully.No further information were provided on this case.

• 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
• 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: 13023166
• MDR Text Key: 286337160
• Report Number: 3004478276-2021-00289
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000825
• UDI-Public: (01)00896208000825(240)PVF-XL(17)220506
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 02/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/06/2022
• Device Model Number: PVF-XL
• Device Catalogue Number: PVF-XL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2020
• 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: 74 YR