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

Catalog Number ICV1346

Device Problem Difficult or Delayed Separation (4044)

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

Event Date 09/21/2021

Event Type  Injury  

Event Description

On (b)(6) 2021, a perceval valve pvs23 was attempted to be implanted as part of an aortic valve replacement procedure.It was reported that no problems were encountered during the valve sizing, collapsing and parachuting.The perceval valve was correctly deployed on the annulus but difficulties were encountered during the retraction of the transparent sheet of the dual holder to deploy the stent in the aorta.The plastic sheath appeared locked.The surgeon attempted several times, while maintaining the holder and the guiding suture in place.At this point, the valve moved up to the annulus, thus the valve had to be removed.The procedure was repeated and the second time the same difficulties were identified during the valve deployment (same dual holder was used).The surgeon pulled strongly on the transparent sheet and finally the valve was successfully deployed.The toe shows good results.There was an extension of 30min to the extracorporeal circulation, but the patient remained stable during the delay in the procedure.

Manufacturer Narrative

The returned accessory (dual holder) was received clean and in general good conditions, without problems in the movement to open/close it.After decontamination, a visual inspection, also by means of the stereoscopic microscope, was performed according to the procedure at the time of manufacture and release.The results confirmed the absence of pre-existing defects in the returned dual holder.A blue trace was noted on the white shaft, that was better documented after the removal of the plastic tube.This blue trace can be reasonably correlated to a forced contact between the two subcomponents.After a complete disassembly, the above-mentioned contact area on the blue piston has been inspected in the frontal and internal surface of the cavity.There, it was possible to clearly see plastic residues reasonably due to two different potential origins: frontal contact and sliding contact between the two plastic components with different coloration (blue and white).The focus of the investigation was then moved on the coupling / sliding system between the components blue piston and white shaft and their dimensional clearance.A dimensional verification has been carried out on all subcomponents to verify the compliance with the manufacturing specifications.The dimensional analysis conducted on each subcomponents confirmed their conformity to the specification.As such, this verification did not show out of tolerance as a possible cause of impediment to free sliding movement.Furthermore, the dhr of the dual holder as part of icv1346 lot# 2101250097, was retrieved and reviewed, confirming that the accessory in object satisfied all material and dimensional requirements for a dual holder s/m at the time of manufacture and release.Based on the analyses conducted and the comparison between the evidence collected on the dual holder received, it is clearly evident that it has been subject to manipulation and forcing.The morphology of the traces indicates two different possible locking configurations.The first is due to over-torsion: this type of locking would be the reason for the two parallel strips of white material and geometrically matching to the two edges between the flat and cylindrical surface of the white shaft.The second is due to an axial forcing that led the blue piston to go beyond the stopping point causing the blue trace on the white plastic and at the same time leaving an almost circular imprint on the front portion of the blue piston.Based on investigations performed, it is not possible to reach an exhaustive conclusion or confirm the root cause of the difficulties encountered.However, no manufacturing deficiencies have been identified in the returned device, which resulted in conformity with the specifications required at the time of manufacture and release.Different possible scenarios have been identified that contemplate maneuvers that could have been carried out involuntarily (eg in the case of blocking) or voluntarily with the intention of solving the problem.

• 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: 12668600
• MDR Text Key: 281840159
• Report Number: 3005687633-2021-00164
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 08022057015228
• UDI-Public: (01)08022057015228(240)ICV1346(17)241026(10)2101250097(11)210125
• 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: 12/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ICV1346
• Device Lot Number: 2101250097
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2021
• 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): Other