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

Catalog Number	ICV1346
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2021
Type of Reportable Event	Serious Injury
Event or Problem 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.

• Brand Name: PERCEVAL SINGLE USE ACCESSORY KIT - DUAL HOLDER
• Common Device Name: TISSUE HEART VALVES ACCESSORY
• Manufacturer (Section D): CORCYM S.R.L.; strada crescentino; saluggia, vercelli 13040 ; IT 13040
• MDR Report Key: 12668674
• Report Number: 3019892983-2021-01025
• Device Sequence Number: 1231296
• Product Code: LWR
• UDI-Device Identifier: 08022057015228
• UDI-Public: (01)08022057015228(240)ICV1346(17)241026(10)2101250097(11)210125
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/20/2021
• Report Date (Section F): 09/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/26/2024
• Device Catalogue Number: ICV1346
• Device Lot Number: 2101250097
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2021
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/21/2021
• Device Age: 8 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/21/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other