MAUDE Adverse Event Report: CORCYM CANADA CORP. PERCEVAL SUTURELESS AORTIC HEART VALVE; TISSUE HEART VALVE

Model Number PVS25

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Insufficient Information (4580)

Event Date 06/25/2021

Event Type  Injury  

Event Description

On (b)(6) 2021, a patient received perceval valve pvs25 as a replacement for another biological valve (details unknown).The procedure was completed with no complications.After the procedure, the valve was displaced and the perceval valve was explanted on (b)(6) 2021.The patient received a crown valve.There was a medical judgement that there was no abnormality identified in the explanted perceval valve.The patient eventually died from other clinical complications after the crown valve implant (submitted with a separate report).No other details are provided at this time.

• Brand Name: PERCEVAL SUTURELESS AORTIC HEART VALVE
• Type of Device: TISSUE HEART VALVE
• Manufacturer (Section D): CORCYM CANADA CORP.; 5005 north fraser way; burnaby, bc V5J 5 M1; CA V5J 5M1
• MDR Report Key: 12279310
• MDR Text Key: 265131294
• Report Number: 1718850-2021-01137
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000436
• UDI-Public: (01)00896208000436(240)ICV1210(17)241217
• Combination Product (y/n): N
• Reporter Country Code: AR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/07/2021,08/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PVS25
• Device Catalogue Number: ICV1210
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/07/2021
• Event Location: Hospital
• Date Report to Manufacturer: 07/07/2021
• Date Manufacturer Received: 07/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR