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

Model Number PVF-L

Device Problem Difficult to Open or Close (2921)

Patient Problem Insufficient Information (4580)

Event Date 08/23/2021

Event Type  Injury  

Event Description

On (b)(6) 2021, a perceval plus valve pvf-l was attempted to be implanted as follows: a size large perceval plus was deployed in the annulus but one commissure tipped up at the non coronary cusp after ballooning.The valve was removed and could not be recollapsed properly again using same accessory kit.It was decided to open a new perceval plus large which was collapsed with no problems using existing collapser and holder.Again the valve was tipped up after ballooning so it was removed, recollapsed and this time snare sutures were used for the guiding loops to ensure valve did not move.The valve was successfully implanted.

• Brand Name: PERCEVAL PLUS 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: 12516545
• MDR Text Key: 272870247
• Report Number: 3019892983-2021-01002
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000818
• UDI-Public: (01)00896208000818(240)PVF-L(17)220506
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/24/2021,09/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/06/2022
• Device Model Number: PVF-L
• Device Catalogue Number: PVF-L
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/24/2021
• Device Age: 16 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/24/2021
• Date Manufacturer Received: 09/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention