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.

• 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 13040 ; IT 13040
• MDR Report Key: 12668674
• MDR Text Key: 278151498
• Report Number: 3019892983-2021-01025
• 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: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/21/2021,10/20/2021

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
• Distributor Facility Aware Date: 09/21/2021
• Device Age: 8 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/21/2021
• Date Manufacturer Received: 09/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other