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

Model Number TBD

Device Problem Difficult or Delayed Separation (4044)

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

Event Date 01/27/2022

Event Type  Injury  

Event Description

On (b)(6) 2022, a perceval valve implant attempt occurred.As reported, the surgeon made three attempts to deploy the perceval valve without success.Based on the medical judgment received, the valve is not involved in the reported event.The difficulties came from the sliding of the dual holder's sheath which was stuck.When the surgeon achieved to unlock the sheath, the valve was deployed in the wrong position.Ultimately, the surgeon used a new perceval valve (of the same size) and a new accessory kit.This time, it was possible to deploy the valve correctly at the first attempt, but still with sliding difficulties.No collapsing difficulties reportedly occurred.As reported, the patient was not adversely impacted by the event.

Event Description

On (b)(6) 2022, a perceval valve implant attempt occurred.As reported, the surgeon made three attempts to deploy the perceval valve without success.Based on the medical judgment received, the valve is not involved in the reported event.The difficulties came from the sliding of the dual holder's sheath which was stuck.When the surgeon achieved to unlock the sheath, the valve was deployed in the wrong position.Ultimately, the surgeon used a new perceval valve (of the same size) and a new accessory kit.This time, it was possible to deploy the valve correctly at the first attempt, but still with sliding difficulties.No collapsing difficulties reportedly occurred.As reported, the patient was not adversely impacted by the event.Per additional information received, the cross-clamp time added was about 20 min.The surgeon decided to use a new kit with the new perceval, so at the third try.The patient remained stable during the procedure, with no impact and good outcome.

Manufacturer Narrative

An updated summary was provided in b5 following receipt of additional information.

Manufacturer Narrative

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 information available, 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.Despite the device involved in the reported event was made available for investigation, it has not yet returned to the manufacturer after almost 90 days.As such, no further investigation is possible at this time.Should the device be eventually received, the manufacturer will perform further investigation and provide a follow up report as applicable.

Manufacturer Narrative

Fields updated: b4, d9, g3, g6, h1, h2, h6.The device involved in the reported event was returned to the manufacturer on 09 jun 2022.The returned material included the perceval s heart valve prosthesis pvs 23/m and the two accessory kits size s/m.Given that the two accessory kits were not otherwise identified by the customer, they have been labelled as ''a'' and ''b'' for investigative purposes.After decontamination, the valve was visually inspected without observing any macroscopic anomalies and/or pre-existing defects according to the specifications conformity.Considering the results of the visual inspection and given that no complaint was raised by the customer regarding the returned prosthesis, no further investigation is deemed necessary at this time for the prosthesis.After the sanitization and cleaning treatment, the accessories were visually inspected, also by means of stereoscopic microscope.No problems were detected in the open and close movement of the dual holder and dual collapser of the two kits received.On the two dual holders, upon closer visual inspection through the transparent plastic tube, it was possible to notice a blue trace on the white shaft, better documented, after the removal of the plastic tube.The 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, where it is 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 dimensional analysis, conducted on the separate components, confirmed their conformity to the specification.As such, the measurements carried out on all subcomponents did not show out of tolerance as a possible cause of impediment to free sliding movement.Based on the investigation performed, no manufacturing nor dimensional deficiencies were identified.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.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.Should the manufacturer receive additional information on the event, further actions may be taken as applicable.

• Brand Name: PERCEVAL S 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: 13581805
• MDR Text Key: 286752752
• Report Number: 3005687633-2022-00101
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 08022057015228
• UDI-Public: (01)08022057015228(240)ICV1346(17)230131(10)1905020249
• 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,Followup
• Report Date: 07/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: TBD
• Device Catalogue Number: TBD
• Device Lot Number: 1905020249
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2019
• 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