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

Model Number PVS21

Device Problems Positioning Failure (1158); Malposition of Device (2616)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/13/2021

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.Since the device disposition is presently unknown (device not returned), no further investigation was possible at this time.Based on the information available, the root cause of the reported event can be traced to an unintended use error (mispositioning) which lead to the intraoperative explant.No manufacturing deficiencies were highlighted during the document review performed.The manufacturer has requested additional information on the event, patient impact and device involved, but no further information has been provided to date.Should any further information be received in the future, an update to this reporting activity will be provided.

Event Description

On (b)(6) 2021, a perceval pvs21 valve implant attempt occurred via midline incision.The valve was explanted intraoperatively due to position error confirmed after declamp.A new perceval valve was implanted with no problem and the procedure was completed.

Event Description

On (b)(6) 2021, a perceval pvs21 valve implant attempt occurred via midline incision.The valve was explanted intraoperatively due to position error confirmed after declamp.A new perceval valve was implanted with no issue and the procedure was completed.Based on the additional information received, patient was stable during the surgery.There was no device malfunction detected and surgeon assessed this event as a procedural related event and reported that this event was not related to the device.

Manufacturer Narrative

Based on the information available and the medical judgement received, the root cause of the reported event can be traced to an unintended use error (mispositioning) which lead to the intraoperative explant.Based on the surgeon assessment, no device malfunction were detected and the event was attributed to the procedure not the device.As such there is no further investigation warranted.

• 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
• Manufacturer (Section G): CORCYM CANADA CORP.; 5005 north fraser way; burnaby, bc
• Manufacturer Contact: francesca crovato ; 5005 north fraser way; burnaby, bc
• MDR Report Key: 12627505
• MDR Text Key: 276413126
• Report Number: 3004478276-2021-00267
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000412
• UDI-Public: (01)00896208000412(240)ICV1208(17)231115
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/04/2022

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
• Device Expiration Date: 11/15/2023
• 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
• Initial Date Manufacturer Received: 09/13/2021
• Initial Date FDA Received: 10/13/2021
• Supplement Dates Manufacturer Received: 12/10/2021
• Supplement Dates FDA Received: 01/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 84 YR
• Patient Sex: Female
• Patient Weight: 43 KG