MAUDE Adverse Event Report: CORCYM S.R.L. PERCEVAL SINGLE USE ACCESSORY KIT - DUAL HOLDER; TISSUE HEART VALVES ACCESSORY

Model Number PVS25

Device Problems Difficult to Open or Close (2921); Difficult or Delayed Separation (4044)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/15/2021

Event Type  malfunction  

Manufacturer Narrative

Submitting one report as event related to dual holder, no valve issue reported.Unknown disposition.

Event Description

On (b)(6) 2021 a perceval pvs 25mm was implanted, the valve did not release smoothly and therefore the valve was seated incorrectly when deployed.On inspection of the deployment the valve did not sit well in the annulus and the coaptation of the leaflets looked compromised.The valve was explanted and a new perceval valve was implanted.It was reported that the patient/ user was not affected.

Manufacturer Narrative

Fields updated: b4, d9, g3, g6, h2, h6.Fields corrected: h1 (malfunction event).A complete manufacturing and material records review for the perceval valve model pvs25 and sn:(b)(6) has been performed.The results confirmed that the device satisfied all material, visual and performance standards required at the time of manufacture and release.The lot# of the dual holder involved is reportedly unknown and thus the manufacturing documents for the accessory could not be reviewed.The manufacturer received the dual holder and the perceval valve on 16 nov 2021.Further investigation will be performed and a supplement report will be provided upon completion of the investigation.

Manufacturer Narrative

Corrected data: d1, d2, d4.The device involved in the reported event has been properly updated.The event reports a potential issue with the accessory (i.E.Difficulties in the deployment) as updated in the dedicated sections.Corrected h6 - device problem code.Fields update: b4, g3, g6, h1, h2, h6.The valve and dual holder were returned to the manufacturer.After decontamination, the valve and accessories were visually inspected without identifying pre-existing defects.The dual holder was in general good conditions except the silicon sheath on the tip damaged, and it was freely moving in the close and open position.The height of each leaflet of the valve was checked using the specific tool and led to compliance.In order to attempt to replicate the reported event, a simulation of collapsing and deployment phases was performed, using the returned pvs 25/l with the returned dual holder (after replacement of the silicon sheath).No problems were encountered positioning the valve and during the collapsing phase.During the simulation of the valve deployment in silicon aortic roots #25 and #23 no problems were encountered during the ballooning phase: the sealing at the annulus level is guaranteed; thus, the valve remained fixed within the annulus.Then, inserting some water in the aortic roots from the outflow side, no paravalvular leaks were observed during both the simulations.Considering the static conditions of the test and despite the residual deformation observed at the inflow side level, the water level remained stable under the leaflets free edge.Furthermore, a complete manufacturing and material records review for the accessory has been performed.The results confirmed that the accessory satisfied all material, visual and performance standards required at the time of manufacture and release.Based on the performed analyses, it is possible to exclude the relationship between the reported event and the returned devices quality.The root cause of the deployment difficulty may be related to procedural/use difficulty that led to valve mispositioning.

• Brand Name: PERCEVAL SINGLE USE ACCESSORY KIT - DUAL HOLDER
• Type of Device: TISSUE HEART VALVES ACCESSORY
• Manufacturer (Section D): CORCYM S.R.L.; strada crescentino; saluggia, vercelli
• Manufacturer (Section G): CORCYM S.R.L.; strada crescentino; saluggia, vercelli
• Manufacturer Contact: francesca crovato ; 5005 north fraser way; burnaby, bc
• MDR Report Key: 12471062
• MDR Text Key: 271475458
• Report Number: 3005687633-2021-00154
• 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: 12/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PVS25
• Device Catalogue Number: ICV1348
• Device Lot Number: 2103040192
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/18/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/04/2021
• 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