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

Model Number PVS27

Device Problems Difficult to Fold, Unfold or Collapse (1254); Insufficient Information (3190)

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

Event Date 11/18/2021

Event Type  malfunction  

Event Description

Received an information that a failure of perceval occurred on (b)(6) 2021.No further details were provided at this time.

Event Description

Received an information that a failure of perceval valve.No further details were provided at this time.Based on additional information received, it was clarified that on (b)(6) 2021, a perceval valve pvs27 was attempted to be collapsed for implantation.As reported, the outflow-ring could not be smoothly placed in the sheath during collapse.Thus, another perceval pvs27 was used and finally implanted during the same day.No definitive answer on the relationship between the event and the device was provided by the physician.It was reported that the physician understands that it is a problem with the push-in operation of the left hand.There was only 10 minutes cross-clamp time and bypass time added as a result of the event.The patient remained stable throughout the procedure.

Manufacturer Narrative

(updated to malfunction based on the new information received confirming no significant delay in the procedure, no complications reported for the patient).The manufacturer received additional information.Further investigation is ongoing.

Manufacturer Narrative

Fields updated: b4, b5, g3, g6, h1, h2, h6.The manufacturing and material records for the perceval heart valve, model #icv1211, s/n # (b)(6), including the nitinol stent component, 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 #icv1211) perceval heart valve at the time of manufacture and release.Since the device and accessories involved in the reported event were not returned from the hospital, no further device investigation is possible and a definitive root cause cannot be established.However, from the document review performed, no manufacturing deficiencies were identified.Given that the event added a short delay to the procedure, the event did not result to any serious injury for the patient who did not suffer any adverse consequences as a result of the event.Should any further information be received in the future, a supplemental report will be provided as deemed relevant.

• 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: 13023363
• MDR Text Key: 285338430
• Report Number: 3004478276-2021-00290
• Device Sequence Number: 1
• Product Code: LWR
• 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,Followup
• Report Date: 02/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/27/2023
• Device Model Number: PVS27
• Device Catalogue Number: ICV1211
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2020
• 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): Other