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

Model Number ICV1242

Device Problem Difficult or Delayed Separation (4044)

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

Event Date 06/10/2021

Event Type  malfunction  

Event Description

On (b)(6) 2021 during the collapsing phase of the perceval valve implanting procedure, the following was encountered as regards to the use of the perceval dual holder s/m accessory: very stiff/jerky movement of handle when releasing the frame (outlet) portion of the valve, i.E.When pulling back the clear sleeve.Additional details from the site confirmed that there was a 20 minutes increase in the cross clamp time, the patient remained stable during the procedure, and with good outcome after ultimately implanting a perceval valve.

Manufacturer Narrative

Fields updated: b4, d9, g3, g6, h1, h2, h6.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.The device was returned to the manufacturer and it was received on 26 jul 2021.Further investigation is ongoing.

Manufacturer Narrative

The device returned to the manufacturer for investigation.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.The dual holder was freely moving in both closed and open position.A damaged area was observed on the silicon sheath covering the white cap of the dual holder.On the dual holder, upon closer visual inspection through the transparent plastic tube, it was possible to notice a blue trace on the white shaft.This finding was better documented after the device disassembly and removal of the plastic tube.The blue traces detected can be reasonably correlated to a forced contact between the two subcomponents.Furthermore, a deformed area was detected in the blue piston.After disassembly, the contact area has been inspected in the frontal and internal surface of the cavity where it is possible to clearly see plastic residues reasonably due to the sliding contact between the two plastic components.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.Based on the analysis performed, 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 the analysis conducted on the returned material, 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 and different possible scenarios have been identified in possible involuntary maneuver that causes the lockage.As such, based on the available information and investigation performed, the most probable root cause of the reported event is attributable to an unintended use error that caused or contributed to the event.

Event Description

On (b)(6) 2021, a perceval valve implant attempt occurred.During the valve deployment with a dual holder s/m, difficulties were detected during the valve delivery in the patient¿s annulus.The blue piston was reportedly stiff and appears to lock when the valve is being deployed.During the first deployment attempt performed by the registrar, when releasing the frame (outlet) portion of the valve (i.E.When pulling back the clear sleeve), a very stiff / jerky movement of handle was noted due to the locking of the blue piston.As a result, the valve failed to be deployed.Thereafter, the surgeon attempted the deployment of the same prosthesis with the same dual holder and experienced the same difficulties.Ultimately, the surgeon managed to deploy the valve successfully in the patient¿s annulus and the procedure was completed uneventfully.As a result of this event, the cross-clamp time was increased by 20min.The patient remained stable during the procedure with a good outcome after surgery.

• Brand Name: DUAL HOLDER S/M - PERCEVAL SINGLE USE ACCESSORY KIT
• Type of Device: TISSUE HEART VALVES ACCESSORY
• Manufacturer (Section D): CORCYM S.R.L.; strada crescentino; saluggia, vercelli
• MDR Report Key: 12140367
• MDR Text Key: 267702163
• Report Number: 3005687633-2021-00144
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• PMA/PMN Number: P150011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 10/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ICV1242
• Device Catalogue Number: ICV1242
• Device Lot Number: 1805090067
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other