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

Model Number PVS21

Device Problem Malposition of Device (2616)

Patient Problem Fistula (1862)

Event Date 07/13/2021

Event Type  Injury  

Manufacturer Narrative

The manufacturing and material records for the perceval heart valve, model #icv1208, s/n # (b)(4), as they pertain to the reported event, were retrieved and reviewed by the manufacturer¿s quality engineering.The results confirmed that this valve satisfied all material, visual, and performance standards required for a (model #icv1208) perceval heart valve at the time of manufacture and release.The manufacturer attempted to follow up on this event however, no further information has been received to date.Based on the information provided the root cause appears to be malpositioning of the perceval valve.Based on the information presented available it is unknown if the fistula was pre existing or occurred during the procedure and what is the relationship to the perceval valve.Based on the dhr there appears to be no issue with the valve, since the valve is not being returned no further investigation can be performed at this time.Should additional information be received at a later stage a follow up report will be provided.

Event Description

On (b)(6) 2021 a perceval valve pvs21was implanted, the valve was placed deep in the right coronary apex and the surgeon decided to explant the valve as the surgeon cared about the fistula in the left coronary apex.The valve was crushed and another perceval valve was implanted.

• 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: 12286120
• MDR Text Key: 265362629
• Report Number: 1718850-2021-01141
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000412
• UDI-Public: (01)00896208000412(240)ICV1208(17)231206
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/13/2021,08/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/06/2023
• Device Model Number: PVS21
• Device Catalogue Number: ICV1208
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/13/2021
• Event Location: Hospital
• Date Report to Manufacturer: 07/13/2021
• Date Manufacturer Received: 07/13/2021
• 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: 77 YR
• Patient Weight: 35